title: Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia

acronym: BAVASI

summary: Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.

ReferenceCitation: Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7.

ReferenceCitation: Frederiksen B, Lanng S, Koch C, Høiby N. Improved survival in the Danish center-treated cystic fibrosis patients: results of aggressive treatment. Pediatr Pulmonol. 1996 Mar;21(3):153-8.

ReferenceCitation: Berkhout MC, van Rooden CJ, Rijntjes E, Fokkens WJ, el Bouazzaoui LH, Heijerman HG. Sinonasal manifestations of cystic fibrosis: a correlation between genotype and phenotype? J Cyst Fibros. 2014 Jul;13(4):442-8. doi: 10.1016/j.jcf.2013.10.011. Epub 2013 Nov 5.

ReferenceCitation: Berkhout MC, Klerx-Melis F, Fokkens WJ, Nuijsink M, van Aalderen WM, Heijerman HG. CT-abnormalities, bacteriology and symptoms of sinonasal disease in children with Cystic Fibrosis. J Cyst Fibros. 2016 Nov;15(6):816-824. doi: 10.1016/j.jcf.2016.03.004. Epub 2016 Apr 3.

ReferenceCitation: Jelsbak L, Johansen HK, Frost AL, Thøgersen R, Thomsen LE, Ciofu O, Yang L, Haagensen JA, Høiby N, Molin S. Molecular epidemiology and dynamics of Pseudomonas aeruginosa populations in lungs of cystic fibrosis patients. Infect Immun. 2007 May;75(5):2214-24. Epub 2007 Jan 29.

ReferenceCitation: Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

ReferenceCitation: Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.

ReferenceCitation: Aanaes K, Johansen HK, Poulsen SS, Pressler T, Buchwald C, Høiby N. Secretory IgA as a diagnostic tool for Pseudomonas aeruginosa respiratory colonization. J Cyst Fibros. 2013 Jan;12(1):81-7. doi: 10.1016/j.jcf.2012.07.001. Epub 2012 Jul 20. Erratum in: J Cyst Fibros. 2013 Dec;12(6):830.

ReferenceCitation: Fischer N, Hentschel J, Markert UR, Keller PM, Pletz MW, Mainz JG. Non-invasive assessment of upper and lower airway infection and inflammation in CF patients. Pediatr Pulmonol. 2014 Nov;49(11):1065-75. doi: 10.1002/ppul.22982. Epub 2014 Jan 25.

ReferenceCitation: Aanæs K. Bacterial sinusitis can be a focus for initial lung colonisation and chronic lung infection in patients with cystic fibrosis. J Cyst Fibros. 2013 Sep;12 Suppl 2:S1-20. doi: 10.1016/S1569-1993(13)00150-1.

ReferenceCitation: Magnin ML, Cros P, Beydon N, Mahloul M, Tamalet A, Escudier E, Clément A, Le Pointe HD, Blanchon S. Longitudinal lung function and structural changes in children with primary ciliary dyskinesia. Pediatr Pulmonol. 2012 Aug;47(8):816-25. doi: 10.1002/ppul.22577. Epub 2012 May 8.

ReferenceCitation: Alanin MC, Nielsen KG, von Buchwald C, Skov M, Aanaes K, Høiby N, Johansen HK. A longitudinal study of lung bacterial pathogens in patients with primary ciliary dyskinesia. Clin Microbiol Infect. 2015 Dec;21(12):1093.e1-7. doi: 10.1016/j.cmi.2015.08.020. Epub 2015 Sep 2.

ReferenceCitation: Alanin MC, Johansen HK, Aanaes K, Høiby N, Pressler T, Skov M, Nielsen KG, von Buchwald C. Simultaneous sinus and lung infections in patients with primary ciliary dyskinesia. Acta Otolaryngol. 2015 Jan;135(1):58-63. doi: 10.3109/00016489.2014.962185. Epub 2014 Nov 5.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


type: Other Identifier

title: Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home

acronym: EzyGain

summary: Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the training work of walking in everyday life compared to a conventional care.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Physique et de Réadaptation - Hôpital F.Widal

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Characterization of Behavioral Disorders and 24 H-melatonin Level in Adults With Smith Magenis Syndrome

acronym: SMS-adults

summary: Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Screening

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hôpital le Vinatier

intervention_type: Biological

status_simplified: Completed


type: Registry Identifier

title: Métabolismes Des caroténoïdes Dans la lumière du Tube Digestif de l'Homme Sain

acronym: CarotenoiDig

summary: Consumption of foods containing carotenoids, as well as vitamin E, have been associated with lower risk of developing a number of chronic diseases. While the parent compounds have largely been assumed to exert protective antioxidant effects, more recent work has suggested that metabolites may be bioactive. Very little attention has been given to the metabolism of these compounds during the digestive process. Our primary aim is to conduct a postprandial feeding study in healthy men to determine the stability of carotenoids and vitamin E during digestion, and to identify the primary metabolites produced in various compartments of the upper gastrointestinal tract and blood during digestion. Targeted metabolites will be identified and quantitated using high-performance liquid chromatography-tandem mass spectrometry methods previously developed. In addition, a non-targeted metabolomics approach will be used to identify non-predicted metabolites in the samples. A better understanding of carotenoid and vitamin E stability and metabolism during digestion will provide greater insight into how these compounds may confer protection against chronic disease.

design_allocation: Randomized

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Kopec RE, Caris-Veyrat C, Nowicki M, Gleize B, Carail M, Borel P. Production of asymmetric oxidative metabolites of [13C]-β-carotene during digestion in the gastrointestinal lumen of healthy men. Am J Clin Nutr. 2018 Oct 1;108(4):803-813. doi: 10.1093/ajcn/nqy183.

name: INRA UMR408, University of Avignon, Avignon, France

name: Human Nutrition Program, The Ohio State University, Columbus, OH

family: Kopec

full_name: Rachel E Kopec

given: Rachel E

sequence: first

family: Caris-Veyrat

full_name: Catherine Caris-Veyrat

given: Catherine

sequence: additional

name: INRA, INSERM, Aix Marseille University, Marseille, France

family: Nowicki

full_name: Marion Nowicki

given: Marion

family: Gleize

full_name: Beatrice Gleize

given: Beatrice

family: Carail

full_name: Michel Carail

given: Michel

family: Borel

full_name: Patrick Borel

given: Patrick

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Clinical Nutrition

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_normalized: HAL

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre d'Investigation Clinique de la Hôpital Conception

intervention_type: Other


title: Interest of a Therapeutic Follow-up of the Cytarabine in the Acute Myeloid Leukaemia: Is There Constitutional Biomarkers

summary:
In this open-label, single-center, non-randomized patients with AML (Acute Myeloid Leukemia) and receiving all induction chemotherapy and consolidation consisting of cytarabine under the care usual for this pathology, will be included. Each patient will be followed and for the development of toxicities, treatment response and progression-free survival. In addition to the usual care set out above, each patient will undergo a series of constitutional genetic investigations conducted by NGS on markers related to pharmacokinetics cytarabine. Another set of blood samples will also calculate, according to a Bayesian approach, individual pharmacokinetics of cytarabine and its metabolite, arabinosine-uracil.

This study should allow the correlation between pharmacogenetics and patient plasma exposure, that would eventually balance improved efficacy / toxicity of this molecule through a customization regimens, achieved so far on a empirical basis. If validation of our data, a dosage of therapeutic pre CDA could help in predicting pharmacodynamics of cytarabine individual dose adjustment, as is done for the 5-FU and DPD.

status: Unknown status

primary_purpose: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille

intervention_type: Genetic

status_simplified: Unknown


title: Therapeutic Care and Education in Endocrinology-Diabetes-Nutrition: Evaluation of the Interest of the APA Educator (Adapted Physical Activity Educator) for the Establishment of Physical Activities in the Management and Prevention of Overweight and Obesity

acronym: APA

summary: An uncontrolled, non-randomized, open-plan, multi-centre study of treatment and therapeutic education in endocrinology-diabetes-Nutrition that seeks to assess the interest of an adapted physical activity educator for the implementation In place of physical activities in the management and prevention of overweight and obesity. The proposed study seeks to promote the physical activity (PA) to patients and employees, including the encouragement of physical activity in a guided and personalized way, through workshops on working time, and follow-up of the evolution of the PA through a Adapted questionnaire.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Nantes University Hospital


title: Effect of Labour on the Gastric Emptying of a Light Meal

acronym: VGObstetric

summary: Current recommendations permit the ingestion of all clear fluids (water, apple juice, black coffee..) during labour. However, regarding food during labour, the recommendations vary. British and European guidelines permit the ingestion of low-residue food during labour whilst guidelines from the United States prohibit having any solid food during labour. The reason for this variation in recommendations is the lack of data on gastric emptying during labour with a conservative approach adopted due to the fear of delayed gastric emptying increasing the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down during labour, using a validated, non-invasive ultrasound method, in four groups of women : Women in labour with epidural analgesia (Analgesia group), women in labor without any epidural analgesia (Parturient group), women in the third trimester of pregnancy (Pregnant group) and women who are not currently pregnant (Non-pregnant control group). The investigator propose the hypothesis that the gastric emptying of a light, solid meal is slowed by 30% during labour under epidural analgesia.

lead_sponsor: Hospices Civils de Lyon


title: Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

acronym: COLORI

summary: Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer


title: Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors

acronym: PrediCTTro

summary:
Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.

The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .

To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.

The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.

The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.

study_start_date_type: Anticipated

time_perspective: Retrospective

location_facility: Centre Français de Référence des Maladies Trophoblastiques


title: High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.

acronym: OxyCOD

summary:
High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.

The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Analyse de la Prise en Charge et de l'Orientation Des Patients de 75 Ans et Plus Consultant Pour Chute Aux Urgences du CHU Angers : données de l'évaluation Initiale et du Recueil de données effectué un an après Leur Passage Aux Urgences

acronym: OREGoN

summary:
The fall is a complex process associated with high morbidity and mortality, with an institutionalization rate of up to 40% and a major socio-economic impact.

The prevalence of falls increases with age. In fact, it is estimated that one-third of people over 65 and 50% of those over 80 living at home fall at least once a year, half of whom fall repeatedly.

For all these reasons, the fall is a frequent reason for emergency consultation, and is an integral part of geriatric syndromes at risk of early readmission.

The care of the elderly patient has been the subject of good practice recommendations by the Health Authority (HAS) in 2009, with the aim of referring patients to specialized geriatric care. Among these recommendations is the need to look for signs of geriatric severity of falls.

To our knowledge, few studies have investigated the applicability of HAS recommendations with the practice of emergencies; this study is part of a project to improve practices.

- Hypothesis : Due to the fast pace of emergency medicine, the complexity of elderly patients and the inherent limitations of the care system, we hypothesize that few serious fallers are included in the geriatric pathway after admission to the emergency room (ER).

lead_sponsor: University Hospital, Angers


title: Coupling Between Saccadic Adaptation and Visuospatial Perception Process: MRI Study in Humans

summary:
Accurate execution of our directed behaviors in the immediate environment allows the vast majority of our daily activities. Through the movements of our eyes and different parts of our body, we perceive, explore and act on our environment and can exchange and communicate with others. The mechanisms of sensorimotor adaptation of saccades (saccadic adaptation) contribute on the one hand to maintain the accuracy of saccades in the short, medium and long term, by opposing the deleterious effects of various physiological changes (development, aging), pathological or environmental (optical corrections).

The aim of this study is to identify neuronal structures and networks involved in saccadic adaptation through the study of brain metabolic activation (BOLD) during the development of the adaptation of reactive saccades. The study will be organized in a single session with 3 runs. Each run include 4 blocks: 3 include the double-step target paradigm RND, U+, U-) and one without target jump (STA). The 'U+'/ 'U-'blocks include saccadic trials with forward/backward displacement of the target during a targeting saccade, the 'RND' block include saccadic trials with random target jump (forward or backward) and the 'STA' block are trials without displacement of the target. Each subject will make 12 repetitions of the 4 blocks.

intervention_type: Behavioral


title: Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents

summary: Essential tremor (TE) is the most common abnormal movement of the adult. His diagnosis is based on a bundle of clinical arguments (Movement Disorders Society, 1998). Well characterized in the adult, little data is available concerning child. The objective of this work is (1) to define the demographic and clinical characteristics of the TE of children and adolescents, (2) to determine the electrophysiological characteristics in the child, (3) evaluate the functional impact of TE, and assess the functional impact of TE, and assess the current management modalities of TE in children and adolescent.

status: Terminated

lead_sponsor: University Hospital, Montpellier


title: Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

acronym: PEEPS

summary: Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope

primary_purpose: Diagnostic


title: Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study

acronym: AMBOST

summary: The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners: a Randomized Trial

summary: We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 13 French departments of general practice.

ReferenceCitation: Jaunay LB, Zerr P, Peguin L, Renouard L, Ivanoff AS, Picard H, Griffith J, Chassany O, Duracinsky M. Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial. J Med Internet Res. 2019 Nov 20;21(11):e12669. doi: 10.2196/12669.

family: Jaunay

full_name: Louis-Baptiste Jaunay

given: Louis-Baptiste

family: Zerr

full_name: Philippe Zerr

given: Philippe

family: Peguin

full_name: Lino Peguin

given: Lino

family: Renouard

full_name: Léandre Renouard

given: Léandre

family: Ivanoff

full_name: Anne-Sophie Ivanoff

given: Anne-Sophie

family: Picard

full_name: Hervé Picard

given: Hervé

family: Griffith

full_name: James Griffith

given: James

family: Chassany

full_name: Olivier Chassany

given: Olivier

family: Duracinsky

full_name: Martin Duracinsky

given: Martin

bso_classification: Medical research

currency_apc_doaj: USD

journal_name: Journal of Medical Internet Research

oa_colors: green gold

evidence: oa journal (via doaj)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

ipd_sharing: Yes

ipd_sharing_description: all collected IPD

lead_sponsor: Hygie

lead_sponsor_type: industriel


title: Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

acronym: K-FPI

summary: Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.


title: Interaction Between Diaphragm and Cardiac Function During Weaning From Mechanical Ventilation

acronym: I-DISCO

summary: Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.


title: Patient Outcomes After an Hospitalization in the Specialized Cognitive-behavioral Unit (UCC) of Toulon

acronym: UCC

summary: The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.

ReferenceType: background

ReferenceCitation: Walsh JS, Welch HG, Larson EB. Survival of outpatients with Alzheimer-type dementia. Ann Intern Med. 1990 Sep 15;113(6):429-34.

ReferenceCitation: Mölsä PK, Marttila RJ, Rinne UK. Survival and cause of death in Alzheimer's disease and multi-infarct dementia. Acta Neurol Scand. 1986 Aug;74(2):103-7.

ReferenceCitation: Edland SD, Rocca WA, Petersen RC, Cha RH, Kokmen E. Dementia and Alzheimer disease incidence rates do not vary by sex in Rochester, Minn. Arch Neurol. 2002 Oct;59(10):1589-93.

ReferenceCitation: Fitzpatrick AL, Kuller LH, Lopez OL, Kawas CH, Jagust W. Survival following dementia onset: Alzheimer's disease and vascular dementia. J Neurol Sci. 2005 Mar 15;229-230:43-9. Epub 2004 Dec 23.

ReferenceCitation: Lee M, Chodosh J. Dementia and life expectancy: what do we know? J Am Med Dir Assoc. 2009 Sep;10(7):466-71. doi: 10.1016/j.jamda.2009.03.014. Epub 2009 Jun 27. Review.

ReferenceCitation: Mitchell SL, Kiely DK, Hamel MB, Park PS, Morris JN, Fries BE. Estimating prognosis for nursing home residents with advanced dementia. JAMA. 2004 Jun 9;291(22):2734-40.

ReferenceCitation: Mitchell SL, Miller SC, Teno JM, Davis RB, Shaffer ML. The advanced dementia prognostic tool: a risk score to estimate survival in nursing home residents with advanced dementia. J Pain Symptom Manage. 2010 Nov;40(5):639-51. doi: 10.1016/j.jpainsymman.2010.02.014.

ReferenceCitation: Mitchell SL, Miller SC, Teno JM, Kiely DK, Davis RB, Shaffer ML. Prediction of 6-month survival of nursing home residents with advanced dementia using ADEPT vs hospice eligibility guidelines. JAMA. 2010 Nov 3;304(17):1929-35. doi: 10.1001/jama.2010.1572.

ipd_sharing_description: There is no plan to share IPD

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


title: Interest of High Fidelity Simulation Training Beginning as Part of the Procedure Tracheobronchial Aspiration

acronym: SIMREAL

summary: The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic.

primary_purpose: Supportive Care


title: Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites at Three Months.

acronym: OnaDEP

summary: The aim of the study is to evaluate in adult subjects with resistant depression the effect of an injection of botulinum toxin in the corrugator and procerus muscles, in comparison to the infiltration of the crow's feet area, in addition to the current antidepressant treatment.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Esquirol


title: Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care (JUVIA)

acronym: JUVIA

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

lead_sponsor: Rennes University Hospital


title: Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

acronym: Protalsafe

summary: Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.

lead_sponsor: Société Guaranteed Gluten Free (GGF)

intervention_type: Dietary Supplement


title: Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin

acronym: HERITOPK

summary:
Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown.

In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Compared to control women, serum AMH level is higher in PCOS women and could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated with the production of AMH.

It is currently described in the literature that daughters of women with PCOS have a 50% risk of developing PCOS, but no genetic cause of transmission is known. In mice (article in press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated that AMH, in its active cleaved form, had a direct central action on the hypothalamus by increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and maternal hypothalamic secretions or by modifying placental steroid production.

Leptin has a role in reproduction, through its receptors located at the central (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.

Will be compare leptin levels in first trimester patients with and without PCOS to look for possible correlations between AMH and leptin and eliminate possible bias.

lead_sponsor: University Hospital, Lille


title: Neural Bases of the Check Process

acronym: Check

summary:
Effective exploration of the environment, check for information to improve one's own performance, are fundamental abilities of human cognition. These abilities are dependent on the process of cognitive control.

However, they are clearly impaired and uncontrollable in certain behavioral disorders such as obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously associated with a feeling of intense uncertainty, suggest disturbances of evaluative and metacognitive functions. However, no biological observations have yet been able to feed these hypotheses.

The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which belongs to a cortico-subcortical network structurally and functionally altered in OCD patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the precise part of the cingulate cortex that contributes to check (and its pathological forms) remains to be discovered.

The purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:

the location and role of the MCC region involved in normal check decision processes,
determine the identity of the entire network involved


type: EudraCT Number

title: Whole Brain Connectivity Changes Induced by Traumatic Coma: Combined Structural, Functional and Neuroinflammatory Approaches

summary: To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

ReferenceCitation: Laureys S, Owen AM, Schiff ND. Brain function in coma, vegetative state, and related disorders. Lancet Neurol. 2004 Sep;3(9):537-46. Review.

ReferenceCitation: Schiff ND. Recovery of consciousness after brain injury: a mesocircuit hypothesis. Trends Neurosci. 2010 Jan;33(1):1-9. doi: 10.1016/j.tins.2009.11.002. Epub 2009 Dec 1. Review.

ReferenceCitation: Silva S, de Pasquale F, Vuillaume C, Riu B, Loubinoux I, Geeraerts T, Seguin T, Bounes V, Fourcade O, Demonet JF, Péran P. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2015 Dec 8;85(23):2036-44. doi: 10.1212/WNL.0000000000002196. Epub 2015 Nov 11.

ReferenceCitation: Chauveau F, Van Camp N, Dollé F, Kuhnast B, Hinnen F, Damont A, Boutin H, James M, Kassiou M, Tavitian B. Comparative evaluation of the translocator protein radioligands 11C-DPA-713, 18F-DPA-714, and 11C-PK11195 in a rat model of acute neuroinflammation. J Nucl Med. 2009 Mar;50(3):468-76. doi: 10.2967/jnumed.108.058669. Epub 2009 Feb 17.

ReferenceCitation: Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

family: Arlicot

full_name: Nicolas Arlicot

given: Nicolas

family: Vercouillie

full_name: Johnny Vercouillie

given: Johnny

family: Ribeiro

full_name: Maria-João Ribeiro

given: Maria-João

family: Tauber

full_name: Clovis Tauber

given: Clovis

family: Venel

full_name: Yann Venel

given: Yann

family: Baulieu

full_name: Jean-Louis Baulieu

given: Jean-Louis

family: Maia

full_name: Serge Maia

given: Serge

family: Corcia

full_name: Philippe Corcia

family: Stabin

full_name: Michael G. Stabin

given: Michael G.

family: Reynolds

full_name: Aaron Reynolds

given: Aaron

family: Kassiou

full_name: Michael Kassiou

given: Michael

family: Guilloteau

full_name: Denis Guilloteau

given: Denis

journal_name: Nuclear Medicine and Biology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Collection of Biological Resources During Medical Care of Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase for an Epigenetic Study of Leukemic Stem Cells

acronym: EPIK

summary: Primary objective : To identify epigenetic dysregulations of in vivo TKI-resisting CML cells Hypothesis : An epigenetic dysregulation is involved in the in vivo survival of a CML cell subclone despite the use of TKIs

lead_sponsor: University Hospital, Clermont-Ferrand


title: SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections

acronym: SELFEPO

summary:
In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Treatment of anemia increases survival, decreases morbidity and improves quality of life and exercise tolerance.

Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few patients are educated in the injection technique.

The investigators therefore wish to lead a study in the Nephrology department of Rennes University Hospital to educate the patient, or his or her spouse, on ESA injections during hospitalization, in order to empower the patient in his care, and with the second aim of reducing the costs of chronic renal insufficiency.


title: Population Pharmacokinetic-pharmacodynamic (PK-PD) Study of 9 Broad-Spectrum Anti-infective Agents in the Cerebro Spinal Fluid (CSF) of Brain Injured Patients With an External Ventricular Drainage (EVD).

summary:
Nosocomial Central Nervous System infections are difficult to treat and an early appropriate therapy can improve prognosis. The two main reasons for treatments failure are the difficulty to reach high concentrations of antibiotics (ATB) in CNS because of brain barriers (BB), and the emergence of Multi-Drug-Resistant (MDR) pathogens that require high ATB concentrations for being killed. Therefore a better knowledge of ATB CNS distribution and PK-PD characteristics is essential for efficiency of treatments and to avoid resistance progression. Because of BB and cerebrospinal fluid (CSF) turnover, unbound (active) concentrations of ATB in CSF are frequently much lower than corresponding plasma concentrations, which therefore may not be used to predict efficacy. However except for patients with EVD, CSF access is difficult. Overall the litterature about ATB distribution within CSF exist but PK-PD publications are rarer. Especially for Broad Spectrum ATB which are recommended in case of invasive infection in ICU patients due to MDR pathogens such as Acinetobacter baumanii, extended spectrum ß-Lactamase producing (ESBL) pathogens or Multiresistant Staphylococcus aureus.

Furthermore, measuring ATB concentrations within the CSF at certain time-points is necessary but not sufficient to predict antimicrobial efficacy. First PK modelling is required to describe the full CSF concentrations versus time profiles. Then targets must be obtained from literature or determined for the relevant PD index, which may be, depending of the antibiotic, Time over Minimal Inhibitrice Concentration (T>MIC), Area Under the Curve over MIC (AUC/MIC) or peak concentration over MIC (Cmax/MIC). Eventually Monte-Carlo simulations can be conducted to predict the probability of target attainment according to various dosing regimens to find the optimal one.

The goal of this multicenter population PK-PD study is to characterize CSF distribution and challenge recommended dosing regimens of 8 ATB indicated in CNS infections (vancomycin, daptomycin, ceftazidime, meropenem, colistin, linezolid, piperacillin-tazobactam and ceftaroline) and to study the Cefepime diffusion in the CSF, known to be highly neurotoxic.

lead_sponsor: Poitiers University Hospital


title: Improving Medication Safety: Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication

summary:
The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department.

The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.

ipd_sharing_description: Not determined


title: Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies

acronym: IMG-COG

summary: To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project.


title: Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE

acronym: MEIBO-ROSACEE

summary: The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

summary: Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

lead_sponsor: University Hospital, Grenoble


title: Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index

acronym: CODEX

summary:
The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm.

Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD.

The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.

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

ReferenceCitation: DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

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

ReferenceCitation: Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

ReferenceCitation: Forgiarini LA Junior, Esquinas AM. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2016 Jul-Aug;42(4):306. doi: 10.1590/S1806-37562016000000099. English, Portuguese.

intervention_type: Diagnostic Test


title: Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level (POEME)

acronym: POEME

summary: The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. the hypothesis is that Eadyn is an indirect reflect of capillary pressure (PCC).

ReferenceCitation: Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.

family: Bar

full_name: Stéphane Bar

given: Stéphane

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Abou-Arab

full_name: Osama Abou-Arab

given: Osama

family: Dupont

full_name: Hervé Dupont

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

journal_name: Frontiers in Physiology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation

acronym: GAVI

summary: The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies (ART) center of Toulouse.


title: Nontechnical Skills Assessment of Emergency Physicians and Quality of Care in a Virtual Emergency Department

summary: The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care.


title: Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors

acronym: KITIV

summary:
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition.

Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.

We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.

ReferenceCitation: Dupont V, Debrumetz A, Leguillou A, Morland D, Wynckel A, Colosio C, Mokri L, Schvartz B, Vuiblet V, Larre S, Barbe C, Rieu P. Intra-abdominal hypertension in early post-kidney transplantation period is associated with impaired graft function. Nephrol Dial Transplant. 2020 Sep 1;35(9):1619-1628. doi: 10.1093/ndt/gfaa104.

name: Department of Nephrology, University Hospital of Reims, Reims, France

full_name: Vincent Dupont

given: Vincent

family: Debrumetz

full_name: Alexandre Debrumetz

given: Alexandre

name: Clinical Research Unit, University Hospital of Reims, Reims, France

family: Leguillou

full_name: Adrien Leguillou

given: Adrien

name: Department of Nuclear Medicine, Jean Godinot Institut, Reims, France

family: Morland

full_name: David Morland

given: David

family: Wynckel

full_name: Alain Wynckel

given: Alain

family: Colosio

full_name: Charlotte Colosio

given: Charlotte

family: Mokri

full_name: Laetitia Mokri

given: Laetitia

family: Schvartz

full_name: Betoul Schvartz

given: Betoul

family: Vuiblet

full_name: Vincent Vuiblet

name: Department of Urology, University Hospital of Reims, Reims, France

family: Larre

full_name: Stephane Larre

given: Stephane

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Rieu

full_name: Philippe Rieu

given: Philippe

journal_name: Nephrology Dialysis Transplantation

lead_sponsor: CHU de Reims


title: Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates: Double Filtration PlasmaPheresis (DFPP) vs Large Plasma Volume Specific ImmunoAdsorption

acronym: DADI

summary:
Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. However, breaking the ABO barrier is possible only with a preconditioning regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of apheresis are available. To date, two main techniques used in clinical setting are the Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP permits the depletion of the selective plasma fraction containing Immunoglobulins, while limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a major loss in essential plasma components. To date, no randomized study comparing DFPP and SIA exist. SIA is less often used because of its high cost. However, in order to reduce the number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A large part of the difference in the cost is related to the apheresis technique.

Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP and SIA to desensitize ABO incompatible kidney transplant candidates.

location_facility: University Hospital Toulouse (Hospital Rangueil)


title: Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome

acronym: SUBOPGEST

summary: The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.

lead_sponsor: University Hospital, Caen


title: Incidence and Risk Factor of Drug Related Problem Detected in Inpatient

acronym: DRPINPAT

summary:
Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines and achieving achieve the desired therapeutic outcomes. Pharmaceutical care identifies and resolves actual or potential DRPs.

DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.

Consequently, the aims of our study were to assess prevalence and characteristics of DRPs identified in inpatient and to identify factors associated with DRPs.

ipd_sharing_description: NC


title: Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

acronym: OCCIA

summary: The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

acronym: EXADOM

summary:
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.

Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.

Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.

ipd_sharing_description: Not provided

location_facility: Emergency Department of University Hospital Grenoble


title: Adaptation of a Knowledges Exchange Portal (KEP) Between Healers and Patients : Study of Obstacles and Sources to the Use of a KEP in the Case of Women Affected by a Breast Cancer in Nouvelle Aquitaine(Sav-AQ)

acronym: Sav-AQ

summary: The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context

lead_sponsor: University Hospital, Bordeaux


title: The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma

acronym: BIGHPANC

summary: The primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I to IV) of pancreatic adenocarcinoma lesion.

lead_sponsor: Centre Leon Berard


title: Retrospective and Prospective Observational Study of MRI Changes in Bone and Visceral Lesions of Patients With Type 1 Gaucher Disease Treated With VPRIV® (Velaglucerase Alfa)

acronym: EIROS

summary:
This study with standardized reading MRIs, will provide for the first time objective and quantified data on organomegaly (liver and spleen volumes) as well as bone alteration (Bone Marrow Burden11) of French patients treated with VPRIV®. These data will help to better assess the impact of this treatment on these parameters.

The result of this study will also answer in part to the request of the French Transparency Commission (CT: Commission de Transparence) of the French National Health Authority to provide them with data of French patients treated with VPRIV®.

time_perspective: Cross-Sectional

lead_sponsor: CEN Biotech


title: Measurement of the Cervix During Pregnancy According to Age of Conization

acronym: MesCon

summary: Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.


title: Comparison of Two Strategies for the Prevention of Endotracheal Tube Cuff Underinflation During Invasive Mechanical Ventilation: Intermittent Versus Continuous Cuff Pressure Control - A Randomised Controlled Study

acronym: CONTIPRESS

summary: During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

ReferenceCitation: Dauvergne JE, Geffray AL, Asehnoune K, Rozec B, Lakhal K. Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomised controlled study. Anaesth Crit Care Pain Med. 2020 Jun;39(3):435-441. doi: 10.1016/j.accpm.2020.04.007. Epub 2020 May 4.

family: Dauvergne

full_name: Jérôme E. Dauvergne

given: Jérôme E.

family: Geffray

full_name: Anne-Laure Geffray

given: Anne-Laure

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Rozec

full_name: Bertrand Rozec

given: Bertrand

family: Lakhal

full_name: Karim Lakhal

journal_name: Anaesthesia Critical Care & Pain Medicine

oa_host_type: publisher

evidence: open (author manuscript)

version: acceptedVersion

lead_sponsor: Nantes University Hospital


title: Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.

acronym: OXMNM

summary:
Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.

The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.

lead_sponsor: University Hospital, Tours


title: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme

acronym: SEPIA

summary:
Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.

The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.

In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.

This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).


title: Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia

acronym: CroyAid-SCZ

summary:
Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.


title: Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors

acronym: REC

summary: To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

ReferenceCitation: Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1.

ReferenceCitation: Repici A, Pellicano R, Strangio G, Danese S, Fagoonee S, Malesci A. Endoscopic mucosal resection for early colorectal neoplasia: pathologic basis, procedures, and outcomes. Dis Colon Rectum. 2009 Aug;52(8):1502-15. doi: 10.1007/DCR.0b013e3181a74d9b. Review.

ReferenceCitation: Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.

ReferenceType: result

ReferenceCitation: Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

name: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Austria

family: Ferlitsch

full_name: Monika Ferlitsch

given: Monika

name: Department of Endoscopic Services, Western Health, Melbourne, Australia

family: Moss

full_name: Alan Moss

given: Alan

name: Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy

family: Hassan

full_name: Cesare Hassan

given: Cesare

name: Solent Centre for Digestive Diseases, Queen Alexandra Hospital, Portsmouth, UK

family: Bhandari

full_name: Pradeep Bhandari

given: Pradeep

name: Gedyt Endoscopy Center, Buenos Aires, Argentina

family: Dumonceau

full_name: Jean-Marc Dumonceau

given: Jean-Marc

name: Department of Gastroenterology, Benizelion General Hospital, Heraklion, Crete, Greece

family: Paspatis

full_name: Gregorios Paspatis

given: Gregorios

name: Unidad de Gastroenterología, Servicio de Medicina Digestiva, Instituto de Investigación Sanitaria ISABIAL, Hospital General Universitario de Alicante, Alicante, Spain

family: Jover

full_name: Rodrigo Jover

given: Rodrigo

name: Department of Pathology, Medical University of Graz, Graz, Austria

family: Langner

full_name: Cord Langner

given: Cord

name: Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

family: Bronzwaer

full_name: Maxime Bronzwaer

given: Maxime

family: Nalankilli

full_name: Kumanan Nalankilli

given: Kumanan

family: Fockens

full_name: Paul Fockens

given: Paul

name: Institute of Gastroenterology and Hepatology, Ha’Emek Medical Center, Afula, Israel and Rappaport Family Faculty of Medicine Technion-Israel Institute of Technology, Haifa, Israel

family: Hazzan

full_name: Rawi Hazzan

given: Rawi

family: Gralnek

full_name: Ian Gralnek

given: Ian

name: Quality Assurance Working Group of the Austrian Society of Gastroenterology and Hepatology

family: Gschwantler

full_name: Michael Gschwantler

given: Michael

family: Waldmann

full_name: Elisabeth Waldmann

given: Elisabeth

family: Jeschek

full_name: Philip Jeschek

given: Philip

family: Penz

full_name: Daniela Penz

given: Daniela

name: Department of Digestive Endoscopy, University Hospital, CHU Fort de France, France

family: Heresbach

full_name: Denis Heresbach

given: Denis

name: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands

family: Moons

full_name: Leon Moons

given: Leon

name: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium

family: Lemmers

full_name: Arnaud Lemmers

given: Arnaud

name: Konstantopoulio General Hospital, Athens, Greece

family: Paraskeva

full_name: Konstantina Paraskeva

given: Konstantina

name: Department of Gastroenterology, Asklepios Klinik Altona, Hamburg, Germany

family: Pohl

full_name: Juergen Pohl

given: Juergen

name: Department of Endoscopy and Gastroenterology, Edouard Herriot Hospital, Lyon, France

family: Ponchon

name: Department of Gastroenterology, Maria Sklodowska-Curie Memorial CancerCenter and Medical Centre for Postgraduate Education, Warsaw, Poland

name: Humanitas Research Hospital, Humanitas University, Rozzano, Milan, Italy

name: School of Medicine, Pharmacy and Health, Durham University, Durham, UK

name: Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26. Review.

name: Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands


title: Nomogram Control of Predictive Factors of Early Withdrawal After Gynecologic Oncology Surgery in the Enhanced Recovery After Surgery (ERAS) Protocol and Assessment of Practices

acronym: NomogramGyneco

summary: Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

ReferenceCitation: Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced Recovery Pathways for Improving Outcomes After Minimally Invasive Gynecologic Oncology Surgery. Obstet Gynecol. 2016 Jul;128(1):138-144. doi: 10.1097/AOG.0000000000001466.

ReferenceCitation: Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394. Review.

ReferenceCitation: Yoong W, Sivashanmugarajan V, Relph S, Bell A, Fajemirokun E, Davies T, Munro K, Chigwidden K, Evan F, Lodhi W; Enhanced Recovery After Surgery (ERAS) Team for Gynaecology and Anaesthesia. Can enhanced recovery pathways improve outcomes of vaginal hysterectomy? Cohort control study. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):83-9. doi: 10.1016/j.jmig.2013.06.007. Epub 2013 Jul 10.

ReferenceCitation: Kroon UB, Rådström M, Hjelthe C, Dahlin C, Kroon L. Fast-track hysterectomy: a randomised, controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):203-7. doi: 10.1016/j.ejogrb.2010.04.001. Epub 2010 May 10.

ReferenceCitation: Borendal Wodlin N, Nilsson L, Kjølhede P; GASPI study group. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):299-308. doi: 10.1111/j.1471-0528.2010.02697.x. Epub 2010 Sep 14.

ReferenceCitation: Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cárdenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.

ReferenceCitation: Bruneau L, Randet M, Evrard S, Damon A, Laurent FX. [Total laparoscopic hysterectomy and same-day discharge: Satisfaction evaluation and feasibility study]. J Gynecol Obstet Biol Reprod (Paris). 2015 Nov;44(9):870-6. doi: 10.1016/j.jgyn.2015.02.003. Epub 2015 Mar 13. French.

ReferenceCitation: Chase DM, Lopez S, Nguyen C, Pugmire GA, Monk BJ. A clinical pathway for postoperative management and early patient discharge: does it work in gynecologic oncology? Am J Obstet Gynecol. 2008 Nov;199(5):541.e1-7. doi: 10.1016/j.ajog.2008.04.037. Epub 2008 Jun 2.

ReferenceCitation: Wijk L, Franzén K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

ReferenceCitation: Lindemann K, Kok PS, Stockler M, Jaaback K, Brand A. Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed. Int J Gynecol Cancer. 2017 Jul;27(6):1274-1282. doi: 10.1097/IGC.0000000000000981. Review.

ReferenceCitation: Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

ReferenceCitation: Schlaerth AC, Abu-Rustum NR. Role of minimally invasive surgery in gynecologic cancers. Oncologist. 2006 Sep;11(8):895-901. Review.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3.

ReferenceCitation: Miralpeix E, Nick AM, Meyer LA, Cata J, Lasala J, Mena GE, Gottumukkala V, Iniesta-Donate M, Salvo G, Ramirez PT. A call for new standard of care in perioperative gynecologic oncology practice: Impact of enhanced recovery after surgery (ERAS) programs. Gynecol Oncol. 2016 May;141(2):371-378. doi: 10.1016/j.ygyno.2016.02.019. Epub 2016 Mar 9. Review.

ReferenceCitation: Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006. Review.

ReferenceCitation: Bauchat JR, Habib AS. Evidence-based anesthesia for major gynecologic surgery. Anesthesiol Clin. 2015 Mar;33(1):173-207. doi: 10.1016/j.anclin.2014.11.011. Epub 2014 Dec 31. Review.

ReferenceCitation: Touijer K, Scardino PT. Nomograms for staging, prognosis, and predicting treatment outcomes. Cancer. 2009 Jul 1;115(13 Suppl):3107-11. doi: 10.1002/cncr.24352. Review.

ReferenceCitation: Potters L, Roach M 3rd, Davis BJ, Stock RG, Ciezki JP, Zelefsky MJ, Stone NN, Fearn PA, Yu C, Shinohara K, Kattan MW. Postoperative nomogram predicting the 9-year probability of prostate cancer recurrence after permanent prostate brachytherapy using radiation dose as a prognostic variable. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1061-5. doi: 10.1016/j.ijrobp.2009.03.031. Epub 2009 Jun 18.

ReferenceCitation: Nixon IJ, Ganly I, Hann LE, Lin O, Yu C, Brandt S, Shah JP, Shaha A, Kattan MW, Patel SG. Nomogram for predicting malignancy in thyroid nodules using clinical, biochemical, ultrasonographic, and cytologic features. Surgery. 2010 Dec;148(6):1120-7; discussion 1127-8. doi: 10.1016/j.surg.2010.09.030.

ReferenceCitation: Barsoum WK, Murray TG, Klika AK, Green K, Miniaci SL, Wells BJ, Kattan MW. Predicting patient discharge disposition after total joint arthroplasty in the United States. J Arthroplasty. 2010 Sep;25(6):885-92. doi: 10.1016/j.arth.2009.06.022. Epub 2009 Sep 2.

ReferenceCitation: Kelly DM, Bennett R, Brown N, McCoy J, Boerner D, Yu C, Eghtesad B, Barsoum W, Fung JJ, Kattan MW. Predicting the discharge status after liver transplantation at a single center: a new approach for a new era. Liver Transpl. 2012 Jul;18(7):796-802. doi: 10.1002/lt.23434.

ReferenceCitation: Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.

ReferenceCitation: Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.

lead_sponsor: Institut Paoli-Calmettes


title: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

summary: Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview

lead_sponsor: Ictal Group

location_facility: Intensive Care Unit - Versailles Hospital


title: Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016

acronym: HEMAJA

summary: Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016

intervention_type: Drug


title: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

acronym: CABRI

summary: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

ReferenceCitation: Hodgson K, Ferrer G, Montserrat E, Moreno C. Chronic lymphocytic leukemia and autoimmunity: a systematic review. Haematologica. 2011 May;96(5):752-61. doi: 10.3324/haematol.2010.036152. Epub 2011 Jan 17. Review.

ReferenceCitation: Dierickx D, Kentos A, Delannoy A. The role of rituximab in adults with warm antibody autoimmune hemolytic anemia. Blood. 2015 May 21;125(21):3223-9. doi: 10.1182/blood-2015-01-588392. Epub 2015 Mar 31. Review.

ReferenceCitation: D'Arena G, Laurenti L, Capalbo S, D'Arco AM, De Filippi R, Marcacci G, Di Renzo N, Storti S, Califano C, Vigliotti ML, Tarnani M, Ferrara F, Pinto A. Rituximab therapy for chronic lymphocytic leukemia-associated autoimmune hemolytic anemia. Am J Hematol. 2006 Aug;81(8):598-602.

ReferenceCitation: Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.

ReferenceCitation: Kaufman M, Limaye SA, Driscoll N, Johnson C, Caramanica A, Lebowicz Y, Patel D, Kohn N, Rai K. A combination of rituximab, cyclophosphamide and dexamethasone effectively treats immune cytopenias of chronic lymphocytic leukemia. Leuk Lymphoma. 2009 Jun;50(6):892-9. doi: 10.1080/10428190902887563.

ReferenceCitation: Rossignol J, Michallet AS, Oberic L, Picard M, Garon A, Willekens C, Dulery R, Leleu X, Cazin B, Ysebaert L. Rituximab-cyclophosphamide-dexamethasone combination in the management of autoimmune cytopenias associated with chronic lymphocytic leukemia. Leukemia. 2011 Mar;25(3):473-8. doi: 10.1038/leu.2010.278. Epub 2010 Dec 3.

ReferenceCitation: Quinquenel A, Willekens C, Dupuis J, Royer B, Ysebaert L, De Guibert S, Michallet AS, Feugier P, Guieze R, Levy V, Delmer A. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS). Am J Hematol. 2015 Mar;90(3):204-7. doi: 10.1002/ajh.23909. Epub 2015 Jan 16.

ReferenceCitation: Maura F, Visco C, Falisi E, Reda G, Fabris S, Agnelli L, Tuana G, Lionetti M, Guercini N, Novella E, Nichele I, Montaldi A, Autore F, Gregorini A, Barcellini W, Callea V, Mauro FR, Laurenti L, Foà R, Neri A, Rodeghiero F, Cortelezzi A. B-cell receptor configuration and adverse cytogenetics are associated with autoimmune hemolytic anemia in chronic lymphocytic leukemia. Am J Hematol. 2013 Jan;88(1):32-6. doi: 10.1002/ajh.23342. Epub 2012 Oct 31.

ReferenceCitation: Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naïve and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.

ReferenceCitation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

family: Byrd

full_name: John C. Byrd

given: John C.

family: Brown

full_name: Jennifer R. Brown

given: Jennifer R.

family: O'Brien

full_name: Susan O'Brien

given: Susan

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

family: Kay

full_name: Neil E. Kay

given: Neil E.

family: Reddy

full_name: Nishitha M. Reddy

given: Nishitha M.

family: Coutre

full_name: Steven Coutre

given: Steven

family: Tam

full_name: Constantine S. Tam

given: Constantine S.

family: Mulligan

full_name: Stephen P. Mulligan

given: Stephen P.

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

family: Devereux

full_name: Steve Devereux

given: Steve

family: Barr

full_name: Paul M. Barr

given: Paul M.

family: Furman

full_name: Richard R. Furman

given: Richard R.

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

family: Cymbalista

full_name: Florence Cymbalista

given: Florence

family: Pocock

full_name: Christopher Pocock

given: Christopher

family: Thornton

full_name: Patrick Thornton

given: Patrick

family: Caligaris-Cappio

full_name: Federico Caligaris-Cappio

given: Federico

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

family: Delgado

full_name: Julio Delgado

given: Julio

family: Schuster

full_name: Stephen J. Schuster

given: Stephen J.

title: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia

ReferenceCitation: Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.

ReferenceCitation: St Bernard R, Hsia CC. Safe utilization of ibrutinib with or without steroids in chronic lymphocytic leukemia patients with autoimmune hemolytic anemia. Ann Hematol. 2015 Dec;94(12):2077-9. doi: 10.1007/s00277-015-2487-8. Epub 2015 Sep 3.

ReferenceCitation: Manda S, Dunbar N, Marx-Wood CR, Danilov AV. Ibrutinib is an effective treatment of autoimmune haemolytic anaemia in chronic lymphocytic leukaemia. Br J Haematol. 2015 Sep;170(5):734-6. doi: 10.1111/bjh.13328. Epub 2015 Feb 25.

ReferenceCitation: Rogers KA, Ruppert AS, Bingman A, Andritsos LA, Awan FT, Blum KA, Flynn JM, Jaglowski SM, Lozanski G, Maddocks KJ, Byrd JC, Woyach JA, Jones JA. Incidence and description of autoimmune cytopenias during treatment with ibrutinib for chronic lymphocytic leukemia. Leukemia. 2016 Feb;30(2):346-50. doi: 10.1038/leu.2015.273. Epub 2015 Oct 7.

ReferenceCitation: Vitale C, Ahn IE, Sivina M, Ferrajoli A, Wierda WG, Estrov Z, Konoplev SN, Jain N, O'Brien S, Farooqui M, Keating MJ, Wiestner A, Burger JA. Autoimmune cytopenias in patients with chronic lymphocytic leukemia treated with ibrutinib. Haematologica. 2016 Jun;101(6):e254-8. doi: 10.3324/haematol.2015.138289. Epub 2016 Mar 24.

ReferenceCitation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

title: Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia


title: Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients

summary:
Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.

Methods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.

lead_sponsor: University Hospital, Montpellier


title: A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

summary:
Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability.

Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of a Training in Therapeutic Education on the Relation Between Care Givers and Their Patients

acronym: METIS

summary:
This study aims to describe the impact of a training in therapeutic education on the relation between a caregiver and his/her patients.

Subjects are recruited among health professionals attending a training in therapeutic education. Then they are asked to identify up to 5 of their patients to be contacted by the researcher for an interview.

Individual semi-structured interviews are conducted with 20 duo "caregivers / patients" before the training, 1 month and 6 months after the training.


title: Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.

acronym: PROSPECT

summary:
Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies.

Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently considered the gold standard device in this field.

The aim of this randomised prospective international study is to assess the efficacy and safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.

ReferenceCitation: Herschorn S, Bruschini H, Comiter C, Grise P, Hanus T, Kirschner-Hermanns R, Abrams P; Committee of the International Consultation on Incontinence. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010;29(1):179-90. doi: 10.1002/nau.20844. Review.

lead_sponsor: Quanta Medical


title: Pain Coping Strategies in Children With Cerebral Palsy

summary: The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.

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

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


title: Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years

acronym: BALISTIC 2

summary:
The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level.

The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms.

The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile.

The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.

status: Enrolling by invitation


title: Evaluation of Full-field Coherence Tomography for ex Vivo Staging and Assessment of Superficial Esophageal Squamous Carcinoma: a Pilot Study

acronym: OESOCiTy

summary:
New tools are needed to 1) diagnose and 2) stage early esophageal squamous cell carcinoma (SCC) in order to improve outcomes of this frequent and lethal cancer.

Optical coherence tomography (OCT) is an optical technique, which can image human tissue ex vivo and in vivo with a resolution around 30µm and with a depth of 1mm. Full-field optical coherence tomography (FFOCT) is a new modality, which allows to image an ex vivo specimen with a cellular resolution and to perform 3D reconstruction. This device has never been tested on esophageal specimens.

Therefore, the aim of this non-interventional research is 1) to determine FFOCT diagnostic criteria for SCC and 2) to figure if FFOCT allows the staging of the depth of invasion in SCC.

To achieve these goals, we will image ex vivo 10 specimens of endoscopic resection of SCC (endoscopic mucosal resection (EMR) and submucosal dissection (ESD)) using an FFOCT device and we will compare the results with histological analysis of these specimens.


title: Phase I Trial of Carbonic Anhydrase Inhibition Associated With Platinum-based Chemotherapy and Etoposide in Concomitance With Radiotherapy in Localized Small Cell Lung Carcinomas

acronym: ICAR

summary:
The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy in localized small cell lung cancer due to:

The over-expression of carbonic anhydrases in this type of cancer,
The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines,
The observed synergy between irradiation and inhibition of carbonic anhydrases,
Potential anti-tumor immune effect caused by decreased extracellular acidity.

lead_sponsor: Centre Antoine Lacassagne


title: RTFM-AB - Repetitive Thinking in FibroMyalgia and Attentional Bias: Links Between Attentional Bias in Later Stages of Attention and Tendency to Repetitive Thinking

acronym: PRFM-BA

summary: Theoretical models of chronic pain hypothesize a privileged treatment of pain-related information that would be the basis of avoidance behaviors in chronic pain. This privileged treatment, also called attentional bias, has been found experimentally in chronic pain. Meta-analyses confirmed that but leaded the question of the difference found between bias in period of attention orientation and bias in period of maintained attention. One of the hypotheses is to consider one or more cognitive processes that would "fix" the attention around significant perceived problems and that would hinder the attentional disengagement and the reorientation of attention towards neutral or positive stimuli. In view of the scientific literature in psychopathology but also in chronic pain we think that the negative repetitive thoughts (RNT) variable is one of these processes. So the investigators want to better understand the difference of attentional bias at different moments of the attentional process by interrogating the Repetitive Thinking variable. More specifically the investigators test the Attentional Bias hypothesis in Fibromyalgia. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales and also the visual probe task. First, the investigators hypothesize the attention bias for pain-related information in the FM group is correlated with the level of negative repetitive thinking in the maintained attention phase. Second, the investigators hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).


title: Influence of the Modulation of the Posterior Parietal Cortex (rTMS) on a Pointing Movement With the Paretic Upper Limb After Stroke

acronym: PPCstim

summary:
This study evaluates the effect of a unique session of inhibitory rTMS (cTBS) over the contralesional posterio parietal cortex (PPC) on the spatio-temporal parameters of a pointing movement performed by stroke patients with their paretic upper limb. It will also assess the effects on the resting motor threshold of both hemispheres and on parietopremotor connectivity.

To achieve theses aims, the real cTBS stimulation will be randomly counterbalanced with a SHAM stimulation (in a second session) in a crossover design. Assessments will be performed before and after each stimulation session.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy Volunteers

summary:
the main objectives are

to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and
to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients.

The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

summary:
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.

High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.

To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.

The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.

This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.

lead_sponsor: CHU de Reims