title: Effects of rTMS Over Right COF Blood Perfusion in OCD Patients: an ASL Double Blinded Study

acronym: ASLTOC

summary:
This study will focus on the use of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment of Obsessive Compulsive Disorder (OCD), which is a common illness that impairs quality of life and that can be hard to treat.

To precisely analyze the effects of rTMS on OCD, the investigators are going to plan a study comparing cerebral blood flow before and after rTMS treatment. The measuring will occur on the Orbito Frontal Cortex (OFC), whose role in OCD has already been shown by our team (Nauczyciel et al, 2014 in Translational Psychiatry), using Magnetic Resonance Imaging in Arterial Spin Labeling, an MRI method allowing to measure arteriola blood flow.

Our primary outcome is to show a significate difference between cerebral blood flow in OCD between one group of participants treated by rTMS and another one treated by placebo. The study will be double blinded with a placebo rTMS machine, monocentric and prospective, with participants suffering from OCD randomized between two groups.

ReferenceCitation: Anticevic A, Hu S, Zhang S, Savic A, Billingslea E, Wasylink S, Repovs G, Cole MW, Bednarski S, Krystal JH, Bloch MH, Li CS, Pittenger C. Global resting-state functional magnetic resonance imaging analysis identifies frontal cortex, striatal, and cerebellar dysconnectivity in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):595-605. doi: 10.1016/j.biopsych.2013.10.021. Epub 2013 Nov 4.

family: Anticevic

full_name: Alan Anticevic

given: Alan

family: Hu

full_name: Sien Hu

given: Sien

family: Zhang

full_name: Sheng Zhang

given: Sheng

family: Savic

full_name: Aleksandar Savic

given: Aleksandar

family: Billingslea

full_name: Eileen Billingslea

given: Eileen

family: Wasylink

full_name: Suzanne Wasylink

given: Suzanne

family: Repovs

full_name: Grega Repovs

given: Grega

family: Cole

full_name: Michael W. Cole

given: Michael W.

family: Bednarski

full_name: Sarah Bednarski

given: Sarah

family: Krystal

full_name: John H. Krystal

given: John H.

family: Bloch

full_name: Michael H. Bloch

given: Michael H.

family: Li

full_name: Chiang-Shan R. Li

given: Chiang-Shan R.

family: Pittenger

full_name: Christopher Pittenger

given: Christopher

journal_name: Biological Psychiatry

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Global Resting-State Functional Magnetic Resonance Imaging Analysis Identifies Frontal Cortex, Striatal, and Cerebellar Dysconnectivity in Obsessive-Compulsive Disorder

ReferenceCitation: van der Straten AL, Denys D, van Wingen GA. Impact of treatment on resting cerebral blood flow and metabolism in obsessive compulsive disorder: a meta-analysis. Sci Rep. 2017 Dec 12;7(1):17464. doi: 10.1038/s41598-017-17593-7.

family: van der Straten

full_name: A. L. van der Straten

given: A. L.

family: Denys

full_name: D. Denys

given: D.

family: van Wingen

full_name: G. A. van Wingen

given: G. A.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

ReferenceCitation: Le Jeune F, Vérin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.

title: Decrease of Prefrontal Metabolism After Subthalamic Stimulation in Obsessive-Compulsive Disorder: A Positron Emission Tomography Study

ReferenceCitation: Nauczyciel C, Le Jeune F, Naudet F, Douabin S, Esquevin A, Vérin M, Dondaine T, Robert G, Drapier D, Millet B. Repetitive transcranial magnetic stimulation over the orbitofrontal cortex for obsessive-compulsive disorder: a double-blind, crossover study. Transl Psychiatry. 2014 Sep 9;4:e436. doi: 10.1038/tp.2014.62.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

ReferenceCitation: Ruffini C, Locatelli M, Lucca A, Benedetti F, Insacco C, Smeraldi E. Augmentation effect of repetitive transcranial magnetic stimulation over the orbitofrontal cortex in drug-resistant obsessive-compulsive disorder patients: a controlled investigation. Prim Care Companion J Clin Psychiatry. 2009;11(5):226-30. doi: 10.4088/PCC.08m00663.

journal_name: The Primary Care Companion to The Journal of Clinical Psychiatry

title: Augmentation Effect of Repetitive Transcranial Magnetic Stimulation Over the Orbitofrontal Cortex in Drug-Resistant Obsessive-Compulsive Disorder Patients

ipd_sharing_description: Data about study protocol and clinical information will be available on request from other researchers. MRI raw data will not be shared but processed data is planned to be available.


title: Clinical Determinants in Perioperative Allergic Immediate Hypersensitivity

acronym: CADECAP

summary:
The clinical presentation of perioperative allergic and non-allergic clinical reactions is often considered undistinguishable while the accurate analysis of clinical cases shows striking clinical differences which might be predictive of the etiological diagnosis (allergic versus non-allergic).

The four-step Ring and Messmer clinical scale helps to guide acute management of immediate hypersensitivity accordingly to the clinical presentation although this scale does not take into account the mechanism involved (i.e. allergic versus non-allergic). Non-allergic clinical reactions are usually non-life-threatening and may, sometimes, spontaneously resolve in contrast to allergic reactions which are mainly severe and life-threatening conditions, typically called anaphylaxis.

The cornerstones of anaphylaxis management are fluid therapy and epinephrine. However, poor outcome has been reported as a result of delayed treatment and/or inappropriate management of perioperative anaphylaxis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique

status_simplified: Completed


type: Registry Identifier

title: Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO

acronym: ECMO-VILI

summary: Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other

status_simplified: Ongoing


title: Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.

summary: To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (LSS).

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Prospective


title: Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

summary:
: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.

The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

intervention_type: Device


title: Evaluation of Immunization Coverage of Premature Infants Leaving CHU d'Angers According to the Recommended Regimen During the First 4 Months (VACCIPREM)

acronym: VACCIPREM

summary:
Premature children are particularly vulnerable in terms of infection and vaccinated in a specific, reinforced vaccination schedule. However, the beginning of the vaccination of these children is often postponed and the vaccination schedule little followed.Concerning the vaccination of premature children, the national recommendations of the High Council of Public Health (HCSP) are different from those of the French experts in pediatric vaccinology. The HCSP recommends a vaccination schedule beginning at the age of 8 weeks postnatal, including, as for full-term infants, two injections at 2-month intervals of vaccine against diphtheria, tetanus, poliomyelitis, haemophilus influenzae B type, whooping cough and hepatitis B. Anti-pneumococcal vaccination is recommended at 2, 3 and 4 months of life.

The French experts of the Infectious Pediatric Pathology Group (GPIP) of the French Pediatric Society recommend a primary vaccination against whooping cough, diphtheria, tetanus, poliomyelitis, Haemophilus Influenzae B (DTPCoqHIB) and hepatitis B at 2, 3 and 4 months for children born before 33 weeks of amenorrhea (WA), and at 2 and 4 months for those born between 33 and 36 weeks + 6 days. Primary anti-pneumococcal vaccination is recommended at 2, 3 and 4 months for all children born prematurely before 37WA.

On the other hand, the cocooning vaccination of the parents against whooping cough is recommended in case of birth at term as of premature birth. This cocooning strategy has not been sufficiently applied, justifying a recall in 2008 for all adults who have not received pertussis vaccination during the last ten years.

The investigators seek to evaluate the follow-up of the recommended vaccination schedule of premature children leaving Angers University Hospital and the reasons associated with the non-monitoring of the calendar in order to identify possible lines of work to improve immunization compliance.

status: Unknown status

ipd_sharing_description: Study openning only in CHU Angers

lead_sponsor: University Hospital, Angers

status_simplified: Unknown


type: Other Identifier

title: Bio Metrology of Nonfibrous Mineral Particles in Bronchoalveolar Lavage Fluids

acronym: REACTIT

summary:
The main purpose of this study is to update the pulmonary retention values of non-fibrous mineral particles in the general population.

This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Study of the Link Between Patient/Psychiatrist Motor Synchronization and Treatment Adhesion in Patients With First Psychotic Episode, ASMASS Project

acronym: ASMASS

summary: The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. This project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. This link could be explained by an association between therapeutic alliance and motor synchronization.

status: Terminated

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral


title: Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever

acronym: ECHOPERY

summary: Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. In order to support this hypothesis, ankle musculoskeletal ultrasound will be performed within 24 hours of onset of ELE in 15 patients diagnosed with FMF. Results will be correlated with clinical parameters, serum inflammatory markers, and ankle radiography.


title: Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients

acronym: OSTEOOL

summary:
The alcohol withdrawal syndrome has a hierarchical symptomatology depending on the severity (minor, moderate or severe). These signs express a state of psychic, behavioral and physical deprivation.

The management of withdrawal syndrome involves the establishment of pharmacological and psychosocial interventions.

Osteopathy is an exclusively manual practice whose purpose is to overcome the dysfunction of mobility of tissues of the human body. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in reducing alcohol withdrawal symptoms in adult patients.


title: Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit

acronym: MUSIDORE

summary:
The aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit.

Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.

location_facility: Hopital Arnaud de Villeneuve- CHU Montpellier


title: Quantification de l'immunité T Anti-CMV à l'Aide d'un Test IGRA Chez Des Patients greffés rénaux et Des Patients dialysés, Comparaison Avec Une Population de témoins

acronym: Quantiferon

summary: Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in kidney transplant recipients and hemodialysis patients, comparison to control patients.

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Radha R, Jordan S, Puliyanda D, Bunnapradist S, Petrosyan A, Amet N, Toyoda M. Cellular immune responses to cytomegalovirus in renal transplant recipients. Am J Transplant. 2005 Jan;5(1):110-7.

ReferenceCitation: Lisboa LF, Kumar D, Wilson LE, Humar A. Clinical utility of cytomegalovirus cell-mediated immunity in transplant recipients with cytomegalovirus viremia. Transplantation. 2012 Jan 27;93(2):195-200. doi: 10.1097/TP.0b013e31823c1cd4.

ReferenceCitation: Kumar D, Chernenko S, Moussa G, Cobos I, Manuel O, Preiksaitis J, Venkataraman S, Humar A. Cell-mediated immunity to predict cytomegalovirus disease in high-risk solid organ transplant recipients. Am J Transplant. 2009 May;9(5):1214-22. doi: 10.1111/j.1600-6143.2009.02618.x.

ReferenceCitation: Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.

ReferenceCitation: Cantisán S, Lara R, Montejo M, Redel J, Rodríguez-Benot A, Gutiérrez-Aroca J, González-Padilla M, Bueno L, Rivero A, Solana R, Torre-Cisneros J. Pretransplant interferon-γ secretion by CMV-specific CD8+ T cells informs the risk of CMV replication after transplantation. Am J Transplant. 2013 Mar;13(3):738-45. doi: 10.1111/ajt.12049. Epub 2013 Jan 11.

ReferenceCitation: Walker S, Fazou C, Crough T, Holdsworth R, Kiely P, Veale M, Bell S, Gailbraith A, McNeil K, Jones S, Khanna R. Ex vivo monitoring of human cytomegalovirus-specific CD8+ T-cell responses using QuantiFERON-CMV. Transpl Infect Dis. 2007 Jun;9(2):165-70.

lead_sponsor: University Hospital, Grenoble

intervention_type: Diagnostic Test


title: NeuroPRotective Effect of remOte Ischemic condiTioning in Ischemic strokE Treated With meChanical Thrombectomy (PROTECT-I Study)

acronym: PROTECT I

summary: The benefit of mechanical thrombectomy in the treatment of ischemic stroke has been demonstrated in several multicenter randomized trials. However, it leads to a sudden reperfusion of the brain parenchyma associated to an extension of the infarct volume. Evidence has indicated that remote ischemic conditioning (RIC) reduces final infarct size in animal stroke models. The main objective of the present study is to determine whether remote ischemic conditioning can limit the final infarct volume after recanalization of the occluded cerebral artery.

primary_purpose: Treatment

lead_sponsor: Hospices Civils de Lyon

location_facility: Service De Neurologie Vasculaire - Hôpital Neurologique Pierre Wertheimer (GHE)


title: Effects of Thigh Cuffs to Prevent the Deconditioning Induced by 5 Days of Dry Immersion Used as a Ground-based Model to Study the Effects of Weightlessness

acronym: DI-Cuff

summary:
The objective of the study is to investigate whether thigh cuffs help to prevent and/or reduce the deconditioning induced by 5 days of dry immersion and in particular the fluid shift and its related ophthalmological disorders. During a randomized 5 day dry-immersion study in 20 healthy male adults the two following aims will be undertaken:

Ten scientific protocols will assess the changes in the cerebral, ocular, cardiovascular, metabolism, cognitive, muscle and bone systems.
In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

primary_purpose: Basic Science

ReferenceCitation: Arbeille P, Herault S, Fomina G, Roumy J, Alferova I, Gharib C. Influences of thigh cuffs on the cardiovascular system during 7-day head-down bed rest. J Appl Physiol (1985). 1999 Dec;87(6):2168-76.

ReferenceCitation: Balasubramanian S, Tepelus T, Stenger MB, Lee SMC, Laurie SS, Liu JHK, Feiveson AH, Sadda SR, Huang AS, Macias BR. Thigh Cuffs as a Countermeasure for Ocular Changes in Simulated Weightlessness. Ophthalmology. 2018 Mar;125(3):459-460. doi: 10.1016/j.ophtha.2017.10.023. Epub 2017 Nov 16.

ReferenceCitation: De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

ReferenceCitation: Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

ReferenceCitation: Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14. Review.

lead_sponsor: Centre National d'Etudes Spatiales


title: Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy

acronym: IPEC

summary: This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.

ipd_sharing: Undecided

location_facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL

intervention_type: Biological


title: Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb

acronym: ICOMI

summary: The assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures The aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: Risk of Allergic Asthma Occurring in the Long Term From an Episode of Acute Bronchiolitis in Infants: Clinical, Allergological and Functional Evaluation in the Long Term

summary:
Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.


title: Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination

acronym: REVISTIM-XX

summary: This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.

lead_sponsor: Nantes University Hospital


title: Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication

acronym: CARBODAV

summary: Intra-operative hemodynamic management in high-risk surgery is a priority for the anesthesiologist. The current strategy is based on the continuous measurement of cardiac output and its maximization by vascular filling has many limitations: invasiveness, measurement difficulties, impaired performance, imperative surgical restriction of filling, lack of evaluation of flow rate and metabolic needs. Biomarkers may be able to detect early an inadequacy between cardiac output and tissue oxygen requirements, venous saturation with oxygen (ScvO2) and arteriovenous difference in partial pressure of carbon dioxide (ΔPCO2) as well as the appearance of cellular hypoxia (lactate and arteriovenous difference in partial pressure of carbon dioxide/arteriovenous difference in oxygen) (ΔPCO2) / DAVO2). Moreover, the medical literature remains poor on the evaluation of these markers in per-operative context all the more for ΔPCO2 and ΔPCO2 / DAVO2. It seems interesting to evaluate the potential of these tools, in patients with major surgery and at high risk (major hepatectomy, oesophagectomy and duodeno-pancreatectomy), to predict the risk of postoperative complications, especially since surgery involves a restrictive vascular filling strategy that may be potentially deleterious to the patient.

intervention_type: Procedure


title: HAP-REPRO: IMPACT OF POLYCYCLIC AROMATIC HYDROCARBONS (PAH) ON IN VITRO FECONDATION: PARENTAL CELLS WITH EARLY EMBRYONIC QUALITY.

summary: The main objective of this study is to highlight a relationship between exposure to PAHs, genotoxic effect biomarkers on spermatozoa and follicular cells, as well as embryonic quality and embryo implantation rates at a given time. IVF attempt. This study therefore analyzes the possibility of using this exposure biomarker as a reliable means of evaluating the quality of gametes in order to estimate the chances of success in IVF.

design_allocation: Non-Randomized


title: Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery.

acronym: EXAECOS

summary: Concussion in sports ("Sports-Related Concussion" or "SRC") are a public health issue. The management of these injuries is evolving rapidly and decisions to return to play are based on clinical judgment. It is now recognized that the assessment of cognitive function must be one of the components of the assessment, in particular, in the protocol used to decide if a patient can resume practice. The available scales include only a brief cognitive assessment but do not provide an understanding of the level of deficit treatment. The use of computerized TAP (Test of Attentionnal Performance) tests, including finer measures of reaction time and apprehending the different attention and executive components (alertnes, orientation, flexibility, inhibition, updating), would allow a better understanding of the nature of the disorder and link it to subjective symptoms, and recovery.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip

summary:
Neurogenic heterotopic ossification (NHO) is defined as an ectopic ossification around proximal joints usually seen after traumatic brain injury, spinal cord injury or polytrauma.

NHO causes pain, partial or total joint ankylosis and vascular or nerve complications.

The osteopenia (low bone density) induced by ankylose increases the fracture risk of femoral neck during the hip surgery performed to remove the NHO.

The analyse of femoral head bone mineral density from hip pre-surgical CT scan could anticipate this kind of complication establishing a presurgical prognostic.

If as it turns out the bone density measured from hip pre-surgical CT scan is relevant fracture risk marker, a preventive osteosynthesis or femoral head and neck resection could be performed in the same time of NHO resection.

ipd_sharing_description: NC


title: A Retrospective Study Assessing the Efficacy and Safety of Triplet Chemotherapy (FOLFIRINOX) Fluorouracil + Oxaliplatin + Irinotecan Plus Cetuximab (ERBITUX®) as First Line Treatment in a RAS (Ras Sarcoma Viral Oncogene Homolog) (KRAS, NRAS) Wild-type Metastatic Colorectal Cancer Population According to BRAF (Murine Sarcoma Viral Oncogene Homolog B) Status and Primary Tumor Location

acronym: ESTER

summary: This retrospective study, will evaluate patient outcomes after triplet chemotherapy (FOLFIRINOX) (5 Fluorouracil + oxaliplatin + irinotecan) plus cetuximab 1st line treatment focusing on efficacy and safety in a RAS (KRAS, NRAS (neuroblastoma rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer population, and according to BRAF (murine sarcoma viral oncogene homolog B) status and primary tumor location.

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

location_facility: Institut régional du cancer de Montpellier

lead_sponsor_type: industriel


title: Balancing of Patients Treated by Vitamin K Antagonists (VKAS) in General Medicine : Study ok Variables Influencing the Time Paid in the Therapeutic Target

acronym: VKA

summary: Despite the rise in prescriptions for direct oral anticoagulants,Vitamin K antagonists(VKA) remains the most prescribed treatment for treating and preventing long-term thromboembolic events. They remain the most important drugs of iatrogenic accidents despite the means deployed by the health authorities. The balance of the patients under VKA can be appreciated thanks to the time spent in the therapeutic zone or TTR which is correlated with the risk of occurrence of haemorrhagic or thrombotic events.


title: Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.

acronym: HERCCULE

summary:
The aim of the present project is to assess the effects of the chronic diseases and their associated treatments chronic paediatric diseases (CPD), to further understand their impact on physical fitness for public health perspectives. This is an innovative approach in the treatment of chronic paediatric diseases . This project should yield results that help improving treatments for children and adolescents with chronic paediatric diseases throughout physical activity as therapy, reduced pain, fatigue and inflammation, and improvement in physical fitness and life quality. The originality and novelty of this project is to combine architectural, functional and metabolic components of skeletal muscle to further understand the impact of chronic paediatric diseases as a function of treatment, disease activity and maturation status (prepubertal, pubertal or post pubertal).

This study will aim at assessing muscular function (force production capacity and fatigability) in specific or ecologic situations so as to get information about muscle functioning on isolated muscle group (here knee extensors) or during whole body exercise. Moreover, results arising from muscle architecture or quality will allow understanding the decrease in strength or endurance reported in the literature. The data collected will allow us to further understand the impact of the disease on structural, functional and metabolic parameters. Finally, the understanding of these alterations will provide information enabling to establish recommendations in physical activity (PA) to reduce or even counter the effect of the chronic inflammation and prevent at long-term overweight and cardiovascular risks.

The long-term objective is to contribute establishing recommendations or guidelines for prescribing physical activity during medical therapy. Values obtained in pathological children will be compared to those of control children matched for gender and maturation.

primary_purpose: Prevention


title: Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study

summary: this project will allow us to evaluate and understand the impact of SLE on the couple's life and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

location_facility: Assitance Publique Hôpitaux de Marseille


title: Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection

summary:
The National Rare Diseases plans, the ongoing MALFPULM PHRC and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. The resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to avoid exceptional tumors. Procedures are ideally performed around the age of 5-6 months to take advantage of the lung growth that continues during the first two years of life. The surgical strategies depend of the malformation size, the tumor risk and surgeon choice: conservative surgery with removal of part of the lobe may be preferred over complete resection of the concerned lobe.

If possible, thoracoscopic resection is carried out. The open thoracotomy is more painful and leads to complications such as thoracic deformities, larger scars, blood loss. However, in infants the thoracoscopic work space is small, lung exclusion is challenging and the anatomy (normal or malformative) is difficult to understand in space. The rate of thoracoscopy without conversion to thoracotomy ranges from 98% in one American center with a more radical approach , to 48% in a national cohort. Pulmonary exclusion failure, complexity and size of malformations and intra-operative complications are factors of conversion to thoracotomy . These factors can lead surgeons to perform thoracotomy without attempting thoracoscopy.

3D printing is a thriving research field for its educational or therapeutic potential optimization of management, prosthesis, and organ replacement. 3D printing is particularly adapted to pediatrics, which suffers from the rarity of its pathologies and a large spectrum of size and morphology prohibiting the mass production of models. 3D printing models of complex pulmonary pathologies will allowed for a better anesthetic and surgical approach. The modeling of bronchial, vascular and even parenchymatous anatomy permits a better understanding of the anatomical particularities of each patient. This, in turn, avoids the intra-operative conversions to thoracotomy with a direct benefit for the patient.


title: Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.

acronym: DCPO Sein

summary: Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy. The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs. In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.

ReferenceType: result

ReferenceCitation: Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

family: Gärtner

full_name: Rune Gärtner

given: Rune

sequence: first

family: Jensen

full_name: Maj-Britt Jensen

given: Maj-Britt

sequence: additional

family: Nielsen

full_name: Jeanette Nielsen

given: Jeanette

family: Ewertz

full_name: Marianne Ewertz

given: Marianne

family: Kroman

full_name: Niels Kroman

given: Niels

family: Kehlet

full_name: Henrik Kehlet

given: Henrik

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Prevalence of and Factors Associated With Persistent Pain Following Breast Cancer Surgery

ReferenceCitation: Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

family: Fuzier

full_name: Régis Fuzier

given: Régis

family: Puel

full_name: Floriane Puel

given: Floriane

family: Izard

full_name: Philippe Izard

given: Philippe

family: Sommet

full_name: Agnès Sommet

given: Agnès

family: Pierre

full_name: Sébastien Pierre

given: Sébastien

journal_name: Journal of Anesthesia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing_description: Will not be shared

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Claudius Regaud - IUCT-Oncopole


title: Interest of Flow Cytometry in Infectious Point of Care: Feasibility Study

summary:
The purpose of this project is to validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.

This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Multi-scale Analysis of Physiological and Pathological Brain Networks by Simultaneous EEG-MEG-SEEG Recordings

acronym: SCALES

summary: The SEEG implantation is performed on purely clinical criteria for preoperative diagnosis. Magnetoencephalography and EEG are purely passive techniques that do not involve any additional risk. This project is a continuation of an existing project in which it was demonstrated the feasibility of simultaneous SEEG and MEG/EEG recordings.


title: Endothelial Dysfunction Could be an Early Biomarker of Renal Impairment in Children and Adolescent With Type 1 Diabetes. Pilot Study DiaDEP

acronym: DiaDEP

summary:
With an increased incidence of pediatric type 1 diabetes (T1D) and a decrease in age at diagnosis, children are exposed to complications such as renal impairment at a very young age.

The current biomarker used to diagnose renal impairment is microalbuminuria, but it's a late marker. Early screening is a major issue to reduce T1D consequences.

Early glomerular hyperfiltration (GHF) could participate in the development and progression of nephropathy. Hyperfiltration has also been associated with a systemic endothelial dysfunction and with changes in arterial stiffness, suggesting, at least to a certain extent, a state of generalized vascular dysfunction.

Diabetes is responsible for very early neurovascular dysfunctions, detectable with techniques to evaluate cutaneous neurovascular interaction. Those should help bringing to light very early microcirculation impairment, particularly precocious endothelial dysfunction (ED).

No study about correlation between GHF and ED is currently available. The hypothesis assessed is those of a strong correlation between ED and GHF in children and adolescent with a story of T1D for at least 10 years.

This pilot study should allow assessing ED's and GHF's proportions in our population, in order to conduct a larger study to prove, in a prospective way, the prognostic value of ED in the apparition of nephropathy, taking into count other factors such as diabetes duration or stability.

This measure could be included in the global evaluation of microangiopathy risk in children and then take action to prevent negative outcomes.

The second aspect of this study is the assessment of other functions and metabolisms possibly impaired in T1D: osseous microarchitecture, vitamin D status and precocious evaluation of macro angiopathy through intima media thickness measurement.

Long term diabetes in children is associated with shorter and leaner bones, despite a correct mineralization, a reduced bone density and a fracture risk increased six fold. Bone status in the population will be evaluated through the study of bones microarchitecture via HR-pQCT (High Resolution peripheral Quantitative Computed Tomography) on both tibia and radius, dual-energy X-ray absorptiometry (DXA), and bone turn over biochemical markers.

Results on bone microarchitecture in a preexisting cohort of healthy children and adolescents will be used to compare results.

location_facility: Hopital Femme Mère Enfant - Groupement Hospitalier Est


title: Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis

acronym: PREXCRIM

summary:
The purpose of this study is to analyze the long-term effects of a physical exercise program on the cardiovascular system of people with Rheumatoid Arthritis (RA).

Indeed, it is recognized that RA patients have cardiovascular problems and that regular physical exercise (exercise training) may be beneficial for the disease complications, incluse the cardiovascular risk. Unfortunately, these patients do not exercise enough for fear of joint pain or for fear of deteriorating their general physical condition.

It is known that intermittent exercises, ie combining low and high intensity work phases, are particularly effective in the cardiovascular field. As it is possible that the high intensity phases be more difficult to sustain than the low intensity phases (joint pain and degradation of the inflammatory status), the investigators propose to study the effects of cold water immersion in the legs after performing this exercise, because the cold being recognized as limiting the pain and improving the inflammatory status.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prospective Study of the Evolution of Symptoms After Sacrospinofixation With Posterior Isthmic Band

acronym: SPIP

summary:
Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life.

Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term.

Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves.

The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care).

Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.

location_facility: Service de gynecologie Hôpital Femme mère enfant


title: Study of the Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus in Liver and Kidney Transplant Patients

acronym: TRANS-TAC

summary: Prospective and monocentric pharmacokinetic study

lead_sponsor: Rennes University Hospital


title: Hemorrhagic Risk and Transfusion Practice Evaluation in Elective Head, Neck and Spine Surgery.

acronym: THANKS

summary:
During elective surgery, the decision to transfuse a patient to correct anemia or an unstable hemodynamic state is often determined on a case by case basis according to personal and hospital transfusion practice. There is wide variability in these practices. Literature suggests that a restrictive transfusion practice is equivalent, if not better, than a liberal practice in terms of morbidity and mortality. However, these data may not be generalizable to specific head, neck, and spine surgeries.

At the head and neck department of Montpellier University Hospital, the hemorrhagic risk has not been precisely measured for certain surgical procedures. Thus hemorrhagic risk tends to be overestimated and unnecessary blood tests tend to be ordered.

In our single center, retrospective, observational study the investigators will determine the hemorrhagic risk related to each elective surgical procedure performed in our center. The investigators will also analyze the transfusion triggers used, and will compare them to national and international recommendations. The results of this study will inform transfusion and laboratory practice for patients undergoing head, neck, or spine surgery.


title: Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial

acronym: LOMBATHERM

summary: The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.

ReferenceType: derived

ReferenceCitation: Forestier R, Suehs C, Françon A, Marty M, Genevay S, Sellam J, Chauveton C, Erol Forestier FB, Molinari N. Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial. Trials. 2020 May 11;21(1):392. doi: 10.1186/s13063-020-04271-9.

family: Forestier

full_name: Romain Forestier

given: Romain

family: Suehs

full_name: Carey Suehs

given: Carey

family: Françon

full_name: Alain Françon

given: Alain

family: Marty

full_name: Marc Marty

given: Marc

family: Genevay

full_name: Stéphane Genevay

given: Stéphane

family: Sellam

full_name: Jérémie Sellam

given: Jérémie

family: Chauveton

full_name: Claire Chauveton

given: Claire

family: Erol Forestier

full_name: Fatma Begüm Erol Forestier

given: Fatma Begüm

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

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

repository_normalized: HAL

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories:
HAL
PubMed Central
unige.ch

title: Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM’ study, a multicentric randomised controlled trial

ipd_sharing: Yes

ipd_sharing_description:
The general goal is to, in as much as possible, make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Due to conditions imposed by French law, data will be made available to the public upon request to the AFRETH scientific committee (Association Française pour la Recherche Thermale, 1 rue Cels 75014 Paris, France; http://www.afreth.org).

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility: Centre de recherche rhumatologique et thermal


type: Other Grant/Funding Number

title: Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions

acronym: BIMEDOC

summary: In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.

lead_sponsor: University Hospital, Toulouse


title: Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results

summary:
The purpose of this study is to evaluate the clinical results and MRI imaging of autologous cartilage reconstructions or collagen matrix of the knee.

There is currently little data in the literature on clinical outcomes and imaging of this type of lesion.

lead_sponsor: Versailles Hospital

intervention_type: Radiation


type: EudraCT Number

title: Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)

acronym: TRAVERS

summary:
Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance).

This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.

lead_sponsor: Auris Medical AG


title: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall

summary: Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Service de Radiologie


title: Self Defining Memories in Women Victims of Intimate Partner Violence: a Pilot Study.

acronym: SOI-MEM

summary: A recent report by the World Health Organization demonstrated that 30 % of women worldwide have been victims of intimate-partner violence (IPV). IPV is a public health problem thus it seems important to propose relevant care. It is difficult to carry out an effective therapy. Psychological care is based on cognitive abilities but these women have cognitive impairment. Few studies investigated their cognitive dysfunction. Investigators suggest in this study an exploration of the Self Defining Memories (SDM) which can highlight the loss of identity of these women and a new target of therapy.


title: Psychological Experience of the End of the Treatment During a Clincal Trial of the Early Ohase and Role of the Initial prédispositions ( VRAIMENT)

acronym: Vraiment

summary: While there is currently some study on the motivations and experiences of patients integrating early phase clinical trials, to our knowledge, no study has explored the future of patients coming out of these trials. It is therefore urgent to better understand the feelings and experiences of patients who discontinue their treatment in a clinical trial of early phase (EP) to provide them with tailored and personalized support. In addition, the end of treatment may have a different impact on the person depending on whether the treatment was discontinued due to the protocol (the patient received the full treatment as planned) or to an early withdrawal (intolerable toxicities or progression of the disease).

primary_purpose: Supportive Care

ReferenceCitation: Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22.

ReferenceCitation: Brédart A, Bodson S, Le Tourneau C, Flahault C, Bonnetain F, Beaudeau A, Coquan E, Dolbeault S, Paoletti X. Patients' perceived tolerance of side effects in phase I cancer clinical trials: A qualitative study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12596. Epub 2016 Oct 12.

ReferenceCitation: Kroenke K, Johns SA, Theobald D, Wu J, Tu W. Somatic symptoms in cancer patients trajectory over 12 months and impact on functional status and disability. Support Care Cancer. 2013 Mar;21(3):765-73. doi: 10.1007/s00520-012-1578-5. Epub 2012 Sep 1.

ReferenceCitation: Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011 Jul;47(10):1490-7. doi: 10.1016/j.ejca.2011.02.020. Epub 2011 Mar 30.

ReferenceCitation: Balbuena L, Bowen R, Baetz M, Marwaha S. Mood Instability and Irritability as Core Symptoms of Major Depression: An Exploration Using Rasch Analysis. Front Psychiatry. 2016 Oct 26;7:174. eCollection 2016.

ReferenceCitation: Tian J, Hong JS. Assessment of the relationship between resilience and quality of life in patients with digestive cancer. World J Gastroenterol. 2014 Dec 28;20(48):18439-44. doi: 10.3748/wjg.v20.i48.18439.

ReferenceCitation: Matzka M, Mayer H, Köck-Hódi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.

ReferenceCitation: Bozo O, Gündogdu E, Büyükasik-Colak C. The moderating role of different sources of perceived social support on the dispositional optimism-- posttraumatic growth relationship in postoperative breast cancer patients. J Health Psychol. 2009 Oct;14(7):1009-20. doi: 10.1177/1359105309342295.

location_facility: Institut régional du Cancer de Montpellier


title: Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of Cirrhosis.

acronym: EmiC

summary:
Cirrhotic patients are at higher risk of sepsis due to impaired innate and adaptive immune responses. Septic complications represent a major issue in the management of cirrhotic patients, with a 1-month mortality rate of 23%, which increases to 80% at 3 months in case of associated organ failure.

Delay to treatment initiation during a septic episode may increase the risk of complications and mortality of cirrhotic patients. However, the inappropriate use of antibiotics exposes cirrhotic patients to the risk of more severe infections due to multi-resistant organisms or fungi.

The use of diagnostic markers for sepsis is limited in the context of cirrhosis because of the lack of hepatic synthesis of these markers on the one hand and non-specific inflammation related to cirrhosis on the other hand.

Therefore, it is necessary to develop new tools for the early diagnosis of sepsis and appropriate management of cirrhotic patients.

The interest of microRNAs (miRNAs) in the diagnosis and prognosis of septic shock has been reported in the general population. No studies have described circulating miRNAs or reported their interest in the diagnosis of sepsis in a population of cirrhotic patients with acute decompensation (AD).

This preliminary study of 800 circulating miRNAs will be performed in a cohort of patients with acute cirrhosis decompensation, for whom the incidence of sepsis is estimated at 40%. The aim to evaluate the interest and feasibility of a larger study on the interest of circulating miRNAs in the early diagnosis of sepsis in cirrhotic patients. The long-term objective of this study is the development of biomarkers for the early management of cirrhotic patients with sepsis and the rationalization of antibiotic use to improve their prognosis.


title: Impact of a Procalcitonin-based Algorithm on Quality of Management in Patients With Uncomplicated Adhesion-related Small Bowel Obstruction Assessed by Textbook Outcome: a Multicenter Cluster-randomized Open-label Controlled Trial. (ALPROC)

acronym: ALPROC

summary: Adhesion-related small bowel obstruction is a common digestive emergency that can be managed either conservatively or surgically. However, the choice between these two approaches can be difficult due to the absence of specific signs. The objective of this study is to evaluate the clinical impact of a procalcitonin-based algorithm.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: School Withdrawal in Adolescents: Impact of the Ambulatory Child Psychiatry Therapeutic Device. Prospective Study

acronym: DESCOL

summary: The aim of the study is to evaluate the impact of the outpatient ambulatory child psychiatric care system on the functioning of anxio-depressive adolescents in school retreat by describing the modalities of individual psychic functioning.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: 1er secteur de psychopathologie de l'enfant et de l'adolescent du Val de Marne


title: Impact of Cefotaxime and Ceftriaxone on the Emergence and Carrying of Multidrug-Resistant Bacteria and Relationship to Residual Antibiotic Levels in Stool

acronym: CROCTX

summary:
Among enterobacteria, the production of ESBL is the first cause of multidrug resistance. The first cases of ESBL-producing enterobacteriaceae (EBLSE) infections were described during the 1980s and subsequently experienced global spread. Since the beginning of the century, the prevalence of EBLSE infections, especially among E. coli and K. pneumoniae, has increased dramatically. The emergence of multidrug-resistant enterobacteria is currently posing a real public health problem. The European antimicrobial resistance surveillance network evaluated, among clinical strains, the resistance rate for 3rd generation cephalosporins (C3G) at 9.5% for Escherichia coli and 28% for Klebsiella pneumoniae. The consequences of multidrug-resistant enterobacterial infections, which are mainly represented by ESBLs, are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase of costs of care).

Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. The study by Goulenok et al. found as a risk factor for EBLSE bacteremia in patients known to be carriers at the rectal level the existence of antibiotic selection pressure and the presence of a urinary catheter. Woerther et al. have explained in their work that the digestive microbiota confers resistance to colonization by BMR. The impact of antibiotics on the latter leads to a probable rupture of this barrier and a loss of this resistance to colonization. In addition, each antibiotherapy does not impact the digestive microbiota equally and it seems that antibiotics with high anti-anaerobic activity or high biliary elimination are the most impacting. It is therefore essential, at a time of multidrug resistance, to focus on the influence of antibiotics on the digestive microbiota and the emergence and carriage of BMR.

Ceftriaxone and cefotaxime are two injectable injectable third-generation cephalosporins (C3G) commonly used in clinical practice. Despite their similar spectrum of action, it should be noted that they have substantially different pharmacokinetic properties, especially with regard to their half-life and their elimination routes (mainly urinary for cefotaxime, mixed: biliary and urinary for ceftriaxone). Some works have already been interested in this topic. Grohs et al. carried out a comparative study between ceftriaxone and cefotaxime on the emergence of AmpC hyperproducing enterobacteria (HL-CASE). This single-site study demonstrated that, at a hospital level, the preferential use of cefotaxime rather than ceftriaxone had collective and ecological benefits at the service level. Indeed, their results conclude that resistance development is weaker, as well as more limited carriage of HL-CASE Enterobacterial strains by replacing ceftriaxone with cefotaxime. It should be noted, however, that the modification of prescribing practices of C3G has been coupled with various measures to limit the emergence of AmpC hyperproductive enterobacteria (reinforcement of hygiene rules, awareness of the health care team at EBLSE, control of antibiotic ...).

In a context where the emergence of multidrug-resistant bacteria continues to increase, it seems appropriate to conduct a study to compare the impact of the use of ceftriaxone or cefotaxime on the emergence of BMR at the individual level. In the absence of a study clearly establishing the link between C3G types (ceftriaxone, cefotaxime) and the emergence of BMR and in line with the above research, this study aims to compare the microbiological impact of the use of either of these two C3Gs (in terms of emergence of bacterial resistance and impact on the diversity and quantity of digestive digestive bacteria). The study will have two periods: Period 1 during which patients hospitalized in the emergency department or in internal medicine and receiving C3G antibiotics will receive ceftriaxone, and the period 2 during which cefotaxime is cephalosporin used in first intention in these same patients.

Thus, this research project, by focusing on these 5 parameters in patients treated with ceftriaxone or cefotaxime, should make it possible to prove the influence of these antibiotherapies on the carriage of BMR (deleterious action on the diversity and the quantity of the intestinal bacterial flora, resulting in an increase in the relative fecal abundance of these BMRs promoting their carriage). In addition, the hypothesis is that, contrary to current data, cefotaxime is found at sufficiently high concentrations in the feces to have an impact on the microbiota equivalent to that of ceftriaxone, despite less significant biliary elimination.

This study therefore aims to compare their impacts on the microbiota and in particular on the emergence of multidrug-resistant bacteria (BMR) and enteropathogens such as Clostridium difficile.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years

summary: Recently, retrospective studies have shown that Down Syndrome children have a higher CO2 (carbone dioxide) sleep pressure than the general pediatric population. This increase does not seem to be always related to sleep apnea. The Investigators wish to confirm these results prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with Down syndrome. .

ReferenceCitation: Feldman JL, Del Negro CA, Gray PA. Understanding the rhythm of breathing: so near, yet so far. Annu Rev Physiol. 2013;75:423-52. doi: 10.1146/annurev-physiol-040510-130049. Epub 2012 Oct 29. Review.

ReferenceCitation: Trang H, Brunet JF, Rohrer H, Gallego J, Amiel J, Bachetti T, Fischbeck KH, Similowski T, Straus C, Ceccherini I, Weese-Mayer DE, Frerick M, Bieganowska K, Middleton L, Morandi F, Ottonello G; European Central Hypoventilation Syndrome Consortium. Proceedings of the fourth international conference on central hypoventilation. Orphanet J Rare Dis. 2014 Dec 5;9:194. doi: 10.1186/s13023-014-0194-5. Review.

ReferenceCitation: Ng DK, Hui HN, Chan CH, Kwok KL, Chow PY, Cheung JM, Leung SY. Obstructive sleep apnoea in children with Down syndrome. Singapore Med J. 2006 Sep;47(9):774-9.

lead_sponsor: Institut Jerome Lejeune


title: The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI

acronym: COLL-BSP

summary: This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

lead_sponsor: University Hospital, Grenoble


title: Needs Assessment After Cancer in Patients Treated for Breast Cancer

acronym: EACE

summary: observational monocentric study

lead_sponsor: Institut Jean-Godinot


title: Screening of Pulmonary Veino Occlusive Disease in Heterozygous EIF2AK4 Mutation Carriers

summary: Pulmonary Veino Occlusive Disease (PVOD) is a rare form of pulmonary arterial hypertension, characterised by a poor prognosis. Recent studies demonstrated that heritable form of pulmonary veino occlusive diseaseis due to bi-allelic mutations in EIF2AK4 gene. heritable pulmonary veino occlusive disease is an autosomal recessive disease. In the french referal center of severe PH, ulmonary veino occlusive disease patients carriers of bi-allelic mutations in EIF2AK4 gene were identified. Genetic counselling in these families allowed to identified herozygous carriers of a single mutation in EIF2AK4 gene. However, to date, nothing is known about the risk of these persons of developping pulmonary diseases. It appears essential to determine the clinical, functional, echocardiographic and radiologics characteristics of these persons, and their risk of developping Pulmonary veino occlusive disease

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Multicentre, Phase 3, Prospective Study With On-line Randomization, in Single Blind Conditions for the Primary Efficacy Endpoint, Controlled, in Two Parallel Groups, Comparing the Efficacy, Tolerability and Safety of actiTENS Versus Level 2 Systemic Analgesics Recommended for the Treatment of Chronic Nociceptive Pain of Moderate to Severe Intensity in Patients Suffering From Osteoarthritis of the Knee

acronym: ArthroTENS

summary: This is a phase 3, multicentre, prospective, single-blind on principal efficacy criterion, 2 parallel groups, randomized, controlled clinical study comparing efficacy and safety of actiTENS versus systemic level 2 analgesics recommended for the treatment of moderate or severe, nociceptive, chronic pain in patients suffering from osteoarthritis of the knee.

lead_sponsor: Sublimed


title: Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study

acronym: COMPIC

summary: This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.

ReferenceCitation: Jackevicius CA, de Leon NK, Lu L, Chang DS, Warner AL, Mody FV. Impact of a Multidisciplinary Heart Failure Post-hospitalization Program on Heart Failure Readmission Rates. Ann Pharmacother. 2015 Nov;49(11):1189-96. doi: 10.1177/1060028015599637. Epub 2015 Aug 10.

name: Western University of Health Sciences, Pomona, CA, USA

name: VA Greater Los Angeles Healthcare System, CA, USA

name: Institute for Clinical Evaluative Sciences, Toronto, ON, Canada

name: University Health Network, Toronto, ON, Canada

family: Jackevicius

full_name: Cynthia A. Jackevicius

given: Cynthia A.

name: University of California, San Francisco Medical Center and School of Pharmacy, San Francisco, CA

family: de Leon

full_name: Noelle K. de Leon

given: Noelle K.

name: California Northstate University College of Pharmacy, Elk Grove, CA

family: Lu

full_name: Lingyun Lu

given: Lingyun

name: University of California, Los Angeles, CA, USA

family: Chang

full_name: Donald S. Chang

given: Donald S.

family: Warner

full_name: Alberta L. Warner

given: Alberta L.

family: Mody

full_name: Freny Vaghaiwalla Mody

given: Freny Vaghaiwalla

journal_name: Annals of Pharmacotherapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Bueno

full_name: Héctor Bueno

given: Héctor

family: Cleland

full_name: John G. F. Cleland

given: John G. F.

family: Coats

full_name: Andrew J. S. Coats

given: Andrew J. S.

family: Falk

full_name: Volkmar Falk

given: Volkmar

family: González-Juanatey

full_name: José Ramón González-Juanatey

given: José Ramón

family: Harjola

full_name: Veli-Pekka Harjola

given: Veli-Pekka

family: Jankowska

full_name: Ewa A. Jankowska

given: Ewa A.

family: Jessup

full_name: Mariell Jessup

given: Mariell

family: Linde

full_name: Cecilia Linde

given: Cecilia

family: Nihoyannopoulos

full_name: Petros Nihoyannopoulos

given: Petros

family: Parissis

full_name: John T. Parissis

given: John T.

family: Pieske

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

ReferenceCitation: Available at: https://academic.oup.com/eurheartj/article/37/27/2129/1748921/2016-ESC-Guidelines-for-the-diagnosis-and. (Accessed: 12th September 2017).

ReferenceCitation: Masters J, Morton G, Anton I, Szymanski J, Greenwood E, Grogono J, Flett AS, Cleland JG, Cowburn PJ. Specialist intervention is associated with improved patient outcomes in patients with decompensated heart failure: evaluation of the impact of a multidisciplinary inpatient heart failure team. Open Heart. 2017 Mar 8;4(1):e000547. doi: 10.1136/openhrt-2016-000547. eCollection 2017.

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

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24. Review.

name: Department of Medicine; McMaster University, and Population Health Research Institute; Hamilton ON Canada

name: Department of Health Research Methods, Evidence, and Impact; McMaster University; Hamilton Canada

name: MRC Epidemiology Unit and UKCRC Centre for Diet and Activity Research (CEDAR), University of Cambridge School of Clinical Medicine; Cambridge Biomedical Campus, Cambridge; UK

name: Division of Epidemiology, Dalla Lana School of Public Health; University of Toronto; Toronto ON Canada

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam the Netherlands

ReferenceCitation: López Cabezas C, Falces Salvador C, Cubí Quadrada D, Arnau Bartés A, Ylla Boré M, Muro Perea N, Homs Peipoch E. Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. Farm Hosp. 2006 Nov-Dec;30(6):328-42. English, Spanish.

ReferenceCitation: Parajuli DR, Franzon J, McKinnon RA, Shakib S, Clark RA. Role of the Pharmacist for Improving Self-care and Outcomes in Heart Failure. Curr Heart Fail Rep. 2017 Apr;14(2):78-86. doi: 10.1007/s11897-017-0323-2. Review.

repository_institution: Flinders University - Flinders Academic Commons

ReferenceCitation: Wan TTH, Terry A, Cobb E, McKee B, Tregerman R, Barbaro SDS. Strategies to Modify the Risk of Heart Failure Readmission: A Systematic Review and Meta-Analysis. Health Serv Res Manag Epidemiol. 2017 Apr 18;4:2333392817701050. doi: 10.1177/2333392817701050. eCollection 2017 Jan-Dec. Review.

name: College of Health and Public Affairs, University of Central Florida, Orlando, FL, USA

name: Florida Hospital Translational Research Institute, Orlando, FL, USA

journal_name: Health Services Research and Managerial Epidemiology

ReferenceCitation: Buckley MS, Harinstein LM, Clark KB, Smithburger PL, Eckhardt DJ, Alexander E, Devabhakthuni S, Westley CA, David B, Kane-Gill SL. Impact of a clinical pharmacy admission medication reconciliation program on medication errors in "high-risk" patients. Ann Pharmacother. 2013 Dec;47(12):1599-610. doi: 10.1177/1060028013507428. Epub 2013 Oct 15.

name: Banner Good Samaritan Medical Center, Phoenix, AZ, USA

name: Greenville Health System, Greenville, SC, USA

name: University of Pittsburgh School of Pharmacy, Pittsburgh, PA, USA

name: University Pittsburgh Medical Center, Pittsburgh, PA, USA

name: University of Maryland Medical Center, Baltimore, MD, USA

title: Impact of a Clinical Pharmacy Admission Medication Reconciliation Program on Medication Errors in “High-Risk” Patients

ReferenceCitation: Warden BA, Freels JP, Furuno JP, Mackay J. Pharmacy-managed program for providing education and discharge instructions for patients with heart failure. Am J Health Syst Pharm. 2014 Jan 15;71(2):134-9. doi: 10.2146/ajhp130103.

name: Oregon Health and Science University (OHSU), Portland.

name: Department of Pharmacy Practice, Oregon State University/OHSU College of Pharmacy.

journal_name: American Journal of Health-System Pharmacy

location_facility: University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals


title: Impact of Deep Endometriosis Surgery on Sexual Health

acronym: SSACE

summary:
Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women.

The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life.

The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent.

Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.

lead_sponsor: Hospices Civils de Lyon


title: Lymphocyte Sub-populations and Auto Immune Diseases : What Type of Profile ? (SPLIT)

acronym: SPLIT

summary: To determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary Sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

lead_sponsor: University Hospital, Brest


title: Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.

acronym: PROVENTIPED

summary: Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.

location_facility: Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: Satisfaction and Long-term Anatomic Efficacy Study on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008

acronym: RICHTER

summary: Satisfaction and Long-term Anatomic Efficacy will be assessed on Patients Who Underwent a Richter Intervention in the Obstetric and Gynecology Department of Foch Hospital Since 2008.

lead_sponsor: Hopital Foch


title: Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension "DECTPH".

acronym: DECTPH

summary: Pathophysiological mechanisms leading to pulmonary hypertension (PH) are complex. Quantitative computed tomography (QCT) can help us to study morphological alterations in patients with PH. These CT morphometrics are useful to predict the degree of PH severity at least in PH secondary to chronic obstructive pulmonary disease (COPD). We hypothesized that assessing lung perfusion using dual energy CT (DECT) can refine our knowledge on PH pathophysiology and help to predict PH severity irrespective of its etiology

lead_sponsor: University Hospital, Bordeaux


title: Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease

summary:
TriAL21 study is an interventional, open, one arm, prospective, national and single center study.

A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.

Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.

ReferenceCitation: Sinai A, Mokrysz C, Bernal J, Bohnen I, Bonell S, Courtenay K, Dodd K, Gazizova D, Hassiotis A, Hillier R, McBrien J, McCarthy J, Mukherji K, Naeem A, Perez-Achiaga N, Rantell K, Sharma V, Thomas D, Walker Z, Whitham S, Strydom A. Predictors of Age of Diagnosis and Survival of Alzheimer's Disease in Down Syndrome. J Alzheimers Dis. 2018;61(2):717-728. doi: 10.3233/JAD-170624.

ReferenceCitation: McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.

ReferenceCitation: Mann DM. Alzheimer's disease and Down's syndrome. Histopathology. 1988 Aug;13(2):125-37. Review.

ReferenceCitation: Coppus A, Evenhuis H, Verberne GJ, Visser F, van Gool P, Eikelenboom P, van Duijin C. Dementia and mortality in persons with Down's syndrome. J Intellect Disabil Res. 2006 Oct;50(Pt 10):768-77. Review.

ReferenceCitation: Lautarescu BA, Holland AJ, Zaman SH. The Early Presentation of Dementia in People with Down Syndrome: a Systematic Review of Longitudinal Studies. Neuropsychol Rev. 2017 Mar;27(1):31-45. doi: 10.1007/s11065-017-9341-9. Epub 2017 Mar 13. Review.

ReferenceCitation: Neale N, Padilla C, Fonseca LM, Holland T, Zaman S. Neuroimaging and other modalities to assess Alzheimer's disease in Down syndrome. Neuroimage Clin. 2017 Nov 6;17:263-271. doi: 10.1016/j.nicl.2017.10.022. eCollection 2018. Review.

ReferenceCitation: Vemuri P, Jack CR Jr. Role of structural MRI in Alzheimer's disease. Alzheimers Res Ther. 2010 Aug 31;2(4):23. doi: 10.1186/alzrt47.

ReferenceCitation: Lleó A, Cavedo E, Parnetti L, Vanderstichele H, Herukka SK, Andreasen N, Ghidoni R, Lewczuk P, Jeromin A, Winblad B, Tsolaki M, Mroczko B, Visser PJ, Santana I, Svenningsson P, Blennow K, Aarsland D, Molinuevo JL, Zetterberg H, Mollenhauer B. Cerebrospinal fluid biomarkers in trials for Alzheimer and Parkinson diseases. Nat Rev Neurol. 2015 Jan;11(1):41-55. doi: 10.1038/nrneurol.2014.232. Epub 2014 Dec 16. Review.

ReferenceCitation: Hulstaert F, Blennow K, Ivanoiu A, Schoonderwaldt HC, Riemenschneider M, De Deyn PP, Bancher C, Cras P, Wiltfang J, Mehta PD, Iqbal K, Pottel H, Vanmechelen E, Vanderstichele H. Improved discrimination of AD patients using beta-amyloid(1-42) and tau levels in CSF. Neurology. 1999 May 12;52(8):1555-62.

ReferenceCitation: KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9.

ReferenceCitation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86.

ReferenceCitation: Deb S, Hare M, Prior L, Bhaumik S. Dementia screening questionnaire for individuals with intellectual disabilities. Br J Psychiatry. 2007 May;190:440-4.

ReferenceCitation: Ball SL, Holland AJ, Huppert FA, Treppner P, Watson P, Hon J. The modified CAMDEX informant interview is a valid and reliable tool for use in the diagnosis of dementia in adults with Down's syndrome. J Intellect Disabil Res. 2004 Sep;48(Pt 6):611-20.

ReferenceCitation: Kim J, Basak JM, Holtzman DM. The role of apolipoprotein E in Alzheimer's disease. Neuron. 2009 Aug 13;63(3):287-303. doi: 10.1016/j.neuron.2009.06.026. Review.

ReferenceCitation: Carmona-Iragui M, Santos T, Videla S, Fernández S, Benejam B, Videla L, Alcolea D, Blennow K, Blesa R, Lleó A, Fortea J. Feasibility of Lumbar Puncture in the Study of Cerebrospinal Fluid Biomarkers for Alzheimer's Disease in Subjects with Down Syndrome. J Alzheimers Dis. 2017;55(4):1489-1496. doi: 10.3233/JAD-160827.


title: Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients

acronym: DEXTER

summary: The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

lead_sponsor: University Hospital, Caen


title: Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity

summary: The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Monitoring Drug-induced Uveitis

acronym: UVETOX

summary: Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study

summary: The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

ipd_sharing_description: Anonymized data will be shared on an appropriate public platform at the time of publication.

lead_sponsor: Association Jean Baptiste Desbrest


title: A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease

acronym: CUREPARK

summary:
This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months:

Group 1 (20 PD patients): bumetanide
Group 2 (20 PD patients): placebo intake identically to group 1.

ReferenceCitation: Damier P, Hammond C, Ben-Ari Y. Bumetanide to Treat Parkinson Disease: A Report of 4 Cases. Clin Neuropharmacol. 2016 Jan-Feb;39(1):57-9. doi: 10.1097/WNF.0000000000000114.

ReferenceCitation: Lozovaya N, Eftekhari S, Cloarec R, Gouty-Colomer LA, Dufour A, Riffault B, Billon-Grand M, Pons-Bennaceur A, Oumar N, Burnashev N, Ben-Ari Y, Hammond C. GABAergic inhibition in dual-transmission cholinergic and GABAergic striatal interneurons is abolished in Parkinson disease. Nat Commun. 2018 Apr 12;9(1):1422. doi: 10.1038/s41467-018-03802-y.

lead_sponsor: B&A Therapeutics


title: Assisted Animal Therapy in a French Intensive Care Unit (ICU): An Open Randomized Study

acronym: ReAnimal

summary:
Assisted animal therapy (AAT) is getting more and more used worldwide, in such areas as gerontology, psychiatry, or oncology. It is a complementary therapy, and benefits for patients are various, including decrease of anxiety. In ICU, some case reports exist, but no study has ever been made in order to prove its benefits, not even its feasibility.

In ReAnimal, the investigator aims to compare a group of patients receiving assisted animal therapy, versus a group of patients not receiving it. Primary objective will be the evolution of anxiety scores between the 2 groups of patients. Secondary objectives will be the comparison of mood scores, post traumatic stress syndrome scores, pain scores, and physiologic parameters such as blood pressure, cardiac frequency. The investigating team will also compare multi drug resistant bacteria incidence between the 2 groups. In the assisted animal therapy group, patients will also be asked to answer a satisfaction questionnaire.

location_facility: Hôpital Edouard Herriot - Anesthesiology department


title: Pathology of Helicases and Premature Aging: Study by Derivation of hiPS

acronym: HeliPS

summary:
Topic of this work is the involvement of replicative helicases in human premature ageing syndrome. Replicative helicases are ubiquitous and essential during numerous reactions of the DNA metabolism.

The family of replicative helicases (RecQL) is involved in the replication/repair of the DNA and in the telomere maintenance. There are 5 enzymes in human and 3 of them are involved in clinically recognizable syndromes: WRN for the Werner syndrome, BLM for the Bloom syndrome and RECQL4 for the Rothmund Thomson syndrome. All are responsive of a high cancer risk due to genomic instability. Molecular and cellular mechanisms involved in these diseases of ageing are unknown. Moreover, for all of them, there is not therapeutic or preventive solution.

lead_sponsor: University Hospital, Montpellier


title: Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.

acronym: Stryker-KneeKG

summary:
The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.


title: Mineral-Nano-Pathology : Wear of Hip Implants

acronym: MINAPUIH

summary:
Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.

The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.

This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.


title: Using Anogenital Distance to Determinate Fetal Gender Beetween 18 et 41 Weeks of Gestation.

acronym: DAG

summary:
The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date.

The study also evaluates the feasibility of the measure and its interobserver variability.

ipd_sharing_description: All collected data that underlie results in a publication


title: Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects

acronym: I-TSPT-R

summary:
In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested.

This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment.

The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.

lead_sponsor: Centre Hospitalier de Niort


title: Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy

acronym: BLIPIC

summary: Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.

lead_sponsor: Centre Hospitalier de Valenciennes


title: Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds

acronym: SLALOM

summary: Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds

lead_sponsor: Lohmann & Rauscher


title: Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

acronym: PAKITO

summary: The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.


title: Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?

summary: The new approach propose in this protocol is based on ultrafast ultrasound and remote palpation of tissue by ultrasonic radiation pressure. Ultrafast ultrasound of biological tissues is based on an innovative ultrasound imaging approach that can image very fast soft tissue events at a rate of several thousands of frames per second and provide quantitative mapping of the elasticity of the tissues. This current project aims is to focus on myocardial rigidity in diastole to better assess the function of the heart failure.

lead_sponsor: French Cardiology Society


title: MEG Versus EEG HR for the Localization of the Epileptogenic Zone as Part of the Pre-surgical Assessment of Epilepsy

acronym: EPIMEEG

summary:
Drug-resistant partial epilepsies are disabling diseases for which surgical treatment may be indicated. The determination of the area to be operated (or 'epileptogenic zone') is based on a bundle of clinical arguments and neuroimaging, having a direct impact on surgical success.

Epileptic patients have electrical abnormalities that can be detected with surface electrophysiological examinations such as surface EEG or MagnetoEncephalography (MEG). The intracerebral source of these abnormalities can be localized in the brain using source modeling techniques from MEG signals or EEG signals if a sufficient number of electrodes is used (> 100, so-called high EEG technique Resolution = EEG HR). EEG HR and MEG are two infrequent state-of-the-art techniques.

The independent contribution of EEG HR and MEG for the localization of the epileptogenic zone has been shown in several studies. However, several modeling studies have shown that MEG and EEG HR have a different detection capacity and spatial resolution depending on the cortical generators studied. Modeling studies suggest that MEG has better localization accuracy than EEG for most cortical sources.

No direct comparison of the locating value of MEG and EEG HR for the localization of the epileptogenic zone has been performed to date in a large-scale clinical study.

In this prospective study, 100 patients with partial epilepsy who are candidates for epilepsy surgery, and for some of them with intracranial EEG recording, will benefit from two advanced electrophysiological examinations including magnetoencephalographic recording (MEG). ) interictal electrophysiological abnormalities and high-resolution EEG recording (128 electrodes) in addition to the usual examinations performed as part of the pre-surgical assessment, prior to cortectomy and / or intracranial EEG recording.

Based on recent work conducted in humans, we postulate:

that the MEG and the EEG HR make it possible to precisely determine the epileptogenic zone, by using two approaches of definition of the epileptogenic zone (zone operated in the cured patients, zone at the origin of the crises during the intracranial recordings), but that the MEG is a little more precise than the EEG HR for the determination of the epileptogenic zone (we will try to highlight a difference of about 10%)
that the quantitative study of the complementarity between EEG HR and MEG for modeling sources of epileptic spikes will show an added value in the use of both methods compared to the use of only one of the two methods
that it is possible to determine the epileptogenic zone by determining the MEG model zone having the highest centrality value (hub) within the intercritical network by studying networks using graph theory.


title: Multicentre Prospective Observational Study: Resentment of Mucocutaneous Manifestations and the Value of Dermatological Examination in the Early Detection of Type 2 Neurofibromatosis in Children Under 15 Years of Age

summary:
.Neurofibromatosis type 2 is an inherently autosomal dominant genetic disease, but cases of mosaicism or de novo mutation are not uncommon. the prevalence is estimated at 1 / 60,000. the clinical presentation is based on the appearance of tumors in the central and peripheral nervous system. The current average age of diagnosis is around 25 to 30 years depending on the studies. Currently, the diagnostic criteria are based on the ENT, neurological and opthalmological manifestations of the disease. Cutaneous manifestations have been described in these patients. Except now, mucocutaneous manifestations of the disease are not taken into account for depisatage or diagnosis.

The purpose of this study would be to identify the different cutaneous and mucosal manifestations in a pediatric population under 15 years of age, and to analyze whether this might be of interest in early detection of the disease in association with other symptoms.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Safety Assessment of Angioplasty Procedures

acronym: SCRAP

summary: Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Perception of Smell and Taste During Antibiotic Treatment

acronym: OGUSTA

summary:
Antibiotic use may be associated with effects on the perception of smell and taste. These effects are poorly known. The mechanisms can be very diverse, and the effect can be very variable depending on the type of antibiotic used, the dose, and the duration.

The aim of this study is to analyze the perception of the taste and olfactory capacities of patients, during an antibiotic treatment.

location_facility: Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon