title: Interest of the Sialendoscopy Associated With a Local Injection of Corticosteroids in the Treatment of Radio-induced Xerostomia in Comparison With the Hygiene Rules: a Prospective Randomized and Controlled Study

acronym: SIALORAD

summary: Xerostomia is defined as the subjective sensation of dry mouth, and may be associated with a reduction in saliva secretion and composition. It is one of the most common complaints found in patients after irradiation in the head and neck area. This complaint is found in a large majority of patients during radiotherapy, continuing for several years after stopping radiotherapy (93% during radiotherapy and 40 to 60% after two years post-radiotherapy). The advent of IMRT (Intensity-Modulated Radiation Therapy) has reduced this complaint, but it still concerns 40% of patients undergoing post-radiotherapy affecting the head and neck. Xerostomia is responsible for pronunciation difficulties, dysphagia, dysgeusia, alteration of the oral condition leading to a significant alteration of the quality of life. This complaint is maximal in the first six months following radiotherapy, then stabilizes or even regresses in the year following radiotherapy but can persist well beyond the end of the irradiation. At present, there are few treatments that have been shown to be truly effective. Systemic treatments (sialogues, cholinergic agonists, parasympathomimetic and muscarinic agonists, corticosteroids, etc.) allow partial improvement with delayed and not prolonged effectiveness. Many studies evaluating the efficacy of these therapies have shown contradictory and insufficient results (less than half of the patients present an improvement under treatment), without ever allowing a complete cure. Surgical treatments by submaxillary gland transfer have also been studied, but at the price of significant morbidity (cervicotomy, risk to the chin nerve in post-radial areas, etc.). Conformational radiotherapy with intensity modulation has made it possible to reduce the severity of xerostomia but does not make it possible to free oneself from this complication. Patients often find themselves reduced to symptomatic adjunctive treatments (gland massage, sprays, hydration, acupuncture...) without curative treatment. There is therefore a real need to respond to the complaint expressed by many patients by proposing an effective and long-lasting therapy.


title: A 3-months, Controlled and Double-blind Trial of the Effectiveness of Music Therapy in the Treatment of Sleep Disorders in General Medicine.

summary: The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Harmat L, Takács J, Bódizs R. Music improves sleep quality in students. J Adv Nurs. 2008 May;62(3):327-35. doi: 10.1111/j.1365-2648.2008.04602.x.

ReferenceCitation: Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010459. doi: 10.1002/14651858.CD010459.pub2. Review.

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ReferenceType: result

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ReferenceCitation: Gangwisch JE, Heymsfield SB, Boden-Albala B, Buijs RM, Kreier F, Pickering TG, Rundle AG, Zammit GK, Malaspina D. Short sleep duration as a risk factor for hypertension: analyses of the first National Health and Nutrition Examination Survey. Hypertension. 2006 May;47(5):833-9. Epub 2006 Apr 3.

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ReferenceCitation: Leger D, Guilleminault C, Dreyfus JP, Delahaye C, Paillard M. Prevalence of insomnia in a survey of 12,778 adults in France. J Sleep Res. 2000 Mar;9(1):35-42.

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ReferenceCitation: Feng F, Zhang Y, Hou J, Cai J, Jiang Q, Li X, Zhao Q, Li BA. Can music improve sleep quality in adults with primary insomnia? A systematic review and network meta-analysis. Int J Nurs Stud. 2018 Jan;77:189-196. doi: 10.1016/j.ijnurstu.2017.10.011. Epub 2017 Oct 23. Review.

family: Feng

full_name: Fan Feng

given: Fan

sequence: first

family: Zhang

full_name: Yingshi Zhang

given: Yingshi

sequence: additional

family: Hou

full_name: Jun Hou

given: Jun

family: Cai

full_name: Jiayi Cai

given: Jiayi

family: Jiang

full_name: Qiyu Jiang

given: Qiyu

family: Li

full_name: Xiaojuan Li

given: Xiaojuan

family: Zhao

full_name: Qingchun Zhao

given: Qingchun

full_name: Bo-an Li

given: Bo-an

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Nursing Studies

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Wang CF, Sun YL, Zang HX. Music therapy improves sleep quality in acute and chronic sleep disorders: a meta-analysis of 10 randomized studies. Int J Nurs Stud. 2014 Jan;51(1):51-62. doi: 10.1016/j.ijnurstu.2013.03.008. Epub 2013 Apr 9. Review.

family: Wang

full_name: Chun-Fang Wang

given: Chun-Fang

family: Sun

full_name: Ying-Li Sun

given: Ying-Li

family: Zang

full_name: Hong-Xin Zang

given: Hong-Xin

title: Music therapy improves sleep quality in acute and chronic sleep disorders: A meta-analysis of 10 randomized studies

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ReferenceCitation: Guétin S, Portet F, Picot MC, Pommié C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.

family: Guétin

full_name: S. Guétin

given: S.

family: Portet

full_name: F. Portet

given: F.

family: Picot

full_name: M.C. Picot

family: Pommié

full_name: C. Pommié

given: C.

family: Messaoudi

full_name: M. Messaoudi

given: M.

family: Djabelkir

full_name: L. Djabelkir

journal_name: Dementia and Geriatric Cognitive Disorders

title: Effect of Music Therapy on Anxiety and Depression in Patients with Alzheimer’s Type Dementia: Randomised, Controlled Study

ReferenceCitation: Jaber S, Bahloul H, Guétin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. Epub 2006 Nov 3. French.

ReferenceCitation: Guétin S, Giniès P, Siou DK, Picot MC, Pommié C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: The Effects of Music Intervention in the Management of Chronic Pain

ReferenceCitation: Guetin S, Portet F, Picot MC, Defez C, Pose C, Blayac JP, Touchon J. [Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Encephale. 2009 Feb;35(1):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French.

title: Intérêts de la musicothérapie sur l’anxiété, la dépression des patients atteints de la maladie d’Alzheimer et sur la charge ressentie par l’accompagnant principal (étude de faisabilité)

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ReferenceCitation: Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8.

ReferenceCitation: Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology. 2005 Jun;14(6):429-41.

ReferenceCitation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213.

ReferenceCitation: Edinger JD, Wohlgemuth WK. Psychometric comparisons of the standard and abbreviated DBAS-10 versions of the dysfunctional beliefs and attitudes about sleep questionnaire. Sleep Med. 2001 Nov;2(6):493-500.

ReferenceCitation: Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. Erratum in: Sleep 1992 Feb;15(1):83.

ReferenceCitation: Wang Q, Chair SY, Wong EM, Li X. The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly. J Altern Complement Med. 2016 Jul;22(7):576-84. doi: 10.1089/acm.2015.0304. Epub 2016 May 25.

name: The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.

name: Faculty of Nursing, College of Medicine, Xian Jiaotong University, Xian, Shaanxi Province, China.

journal_name: The Journal of Alternative and Complementary Medicine

location_facility: Versailles-Saint Quentin en Yvelines University


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

acronym: RECOVER

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

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

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

acronym: Covid-Impact

summary: The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Identifier

title: Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit

acronym: PROMESREA

summary:
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s).

Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors.

A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown.

Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).

primary_purpose: Prevention

location_facility: Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP

intervention_type: Procedure


title: Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study

summary: Evaluation of the equivalence of 6-minute walking test performed on a non-motorized treadmill to the reference test : a 6-minute walking test on a corridor.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hopital Foch

intervention_type: Diagnostic Test


title: A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regimen

acronym: DORAL

summary:
The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load < 50 copies/mL and nearly 60% had CD4 > 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH.

The current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfunction. HIV infected patients are at a greater risk for such abnormalities. Another crucial concern is the high probability of drug-drug interactions in HIV-infected patients, between ART and comedications.

Alternative strategies are needed, which must address the following questions: how to maintain the control of HIV viral replication while minimizing the occurrence of long-term clinical and metabolic complications, and minimizing the risk of drug-drug interactions?

This study is an open label, randomized, switch study over 96 weeks in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

intervention_type: Drug

lead_sponsor_type: industriel


title: Epidemiological Study of the Spread of SARS-CoV-2 in the Household of a Person Who Has Had a COVID-19 Disease

acronym: FAMICOV

summary:
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus.

Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach.

As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people.

All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved.

If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus.

The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

status_simplified: Completed


title: Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia: the LPSARS2 Study

summary: Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, particularly MERS-CoV (Middle East Respiratory Syndrome), its spread is considerably bigger. As a result, the number of patients developing respiratory distress that require an invasive mechanical ventilation is high, with prolonged ventilation duration in these situations.


title: Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire

acronym: NPSI

summary:
Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.

A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).

Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.


title: Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)

summary:
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.

Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.

primary_purpose: Screening

lead_sponsor: Fondation Ellen Poidatz

intervention_type: Device


title: Evaluation of the Release of Monomers From Composite Bonding Resins in Orthodontics

acronym: MONORTHO

summary:
In recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Many concerns are expressed about the impact of these substances, present in the environment or in consumer products, on the hormonal system. Effects have been observed in animals in experimental studies, but the question of extrapolating these results to humans arises, especially for exposures at low doses.

In orthodontics, the composite is the material of choice mainly for bonding fasteners, then bonding a compression wire. These composite materials contain many monomers. The polemics launched on Bisphenol A and the questions of our patients on the nature and toxicity of dental products oblige us to reflect on their harmfulness after their placement in the oral cavity. Many questions arise today about dental composites and their participation in the release of endocrine disruptors. Indeed, Bisphenol A is used in the manufacturing process of the monomers of orthodontic composites, as precursors of Bis-GMA and Bis-DMA. The objective of this study is to search for the presence of BPA, TEGDMA, BisGMA, BisDMA and UDMA monomers, and to carry out the samples and their analysis at different clinical times (at T0, after the removal of orthodontic attachments, after the placement of the compression, one hour later, one week later, one month later and 6 months later). Studies have been performed in vitro, but very little in vivo. In addition, these studies are only carried out on release at the time of installation, but few are interested in the continuation of the phenomenon over time and the deterioration of the composite. Although the short-term toxicity of BPA is low, its dangerousness lies in its potential endocrine disrupting effect and which can induce long-term chronic toxicity.

Compounds such as TEGDMA, BisGMA, BisDMA and UDMA differ greatly in their volatility due to their different chemical structures as well as in their stability in saliva; Many methods have been developed to study each monomer individually or to study them simultaneously using different analytical techniques to determine their presence and to quantify them after their release from dental products. The analysis of the samples is carried out by liquid chromatography (HPLC).

location_facility: Service Odontology, Hôpital Pitié-Salpêtrière


title: Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey

summary: Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic patients, surgery remains questionable. Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.

lead_sponsor: Hospices Civils de Lyon


title: Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment

acronym: POESY

summary: Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Gérond'if

intervention_type: Behavioral


title: Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)

acronym: RAVI

summary: The main purpose of this study is to assess the tolerance of the virtual environment in the elderly living in a nursing home (EHPAD). It will be evaluated by the cybersickness collection after each session (1 session every other day for a total of 3 sessions).

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Geriatric Department, Paul Brousse Hospital


title: Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics

acronym: ELISA

summary: The main purpose of this monocentric, non-interventional, prospective study carried out in acute geriatrics (UGA) and post-rehabilitation care, is to determine if eosinopenia is associated with bacterial infections.


title: National French Survey on Psychological Distress at Work of Anesthesia and Intensive Care Residents

acronym: PSY-DESAR

summary: Psychological distress is a significant problem for healthcare professionals and students in training. The investigator question the prevalence of this problem in French residents in anaesthesia and intensive care training.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: At the end of the survey

lead_sponsor: Facteurs Humains en Santé


title: Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation

acronym: HSC

summary: This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.


title: Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

acronym: INDYD

summary:
Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.

Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.

DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.

The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.

lead_sponsor: CMC Ambroise Paré


title: Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?

acronym: Happy-Fiv

summary:
Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.

HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.

Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.


title: Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers

acronym: OROPAP

summary: The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

ipd_sharing_description: Individual participant data that underlie results in publication could be shared. Individual participant data detailed in meta analysis protocol could be shared


title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin

summary: The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.

status: Unknown status

lead_sponsor: ValoTec

status_simplified: Unknown


title: "Fetal Aneuploidy Screening (21, 18 and 13) by Analysis of Circulating Fetal DNA in a Population of Pregnant Patients With Autoimmune Diseases"

acronym: AFFEPI

summary:
In the plasma of any pregnant patient circulates DNA (also called circulating free DNA). The vast majority of this circulating free DNA is of maternal origin and about 10% is of fetal origin (fetal circulating free DNA). This percentage of fetal circulating free DNA (corresponding to the fetal fraction) increases with gestation.

The pathophysiological hypothesis of this research is that there is a change in the fetal fraction (FF) of fetal circulating free DNA in patients with autoimmune disease (AID). The underlying mechanism would be a massive release of maternal cfDNA responsible for a dilution of fetal cfDNA. This dilution of fetal cfDNA would result in a decrease in the estimate of the foetal fraction of circulating free DNA. However, when the foetal fraction of circulating free DNA is insufficient (4% most often), screening for Trisomy 21 (T21) by fetal circulating free DNA becomes uninterpretable (NC for "non-contributory" result), and cannot be used to assess the risk of T21. In this case, the dose of fetal circulating free DNA can be performed again after 15 days, as the amount of fetal circulating free DNA increases with gestation. In a small number of cases the result will remain NC.

As tests using DNA are becoming more widespread, it is important to prospectively evaluate the results of these tests in the population of patients with AID, which represents about 3 to 5% of pregnant women.

primary_purpose: Diagnostic

intervention_type: Biological


title: Eye-ECG Approach to Emergencies : Diagnostic Performance of the HINTS Test Performed by Emergency Physicians to Distinguish a Central Cause From a Peripheral Cause of Isolated Acute Vestibular Syndrome

summary:
Vertigo integrated with acute vestibular syndrome (AVS) is a frequent reason for emergency visits. The French and international literature estimates between 2 to 4% of vertigo prevalence among reasons for coming to emergencies. International classifications define AVS as vertigo or acute dizziness (less than one month) and persistent, gait instability, nausea or vomiting, nystagmus or an intolerance to head movements.

In emergency departments, the clinical approach of vertiginous patients is difficult because the "vertigo" term is sometimes used in by patients, or because they use the terms "uneasiness", "vertigo", or "dizziness" without distinction. These terms sometimes include various sensations of "sleeping head", "blurred vision", "instability", "pitch" etc. A first difficulty is therefore to clarify these terms and organize syndrome expressed by the patient. A rigorous interrogation is therefore essential and can be time-consuming.

Another difficulty is to carry out an exhaustive clinical examination including the assessment of the general condition and hydration, an ENT examination and a neurological examination. However, at the end of these steps, the orientation central or peripheral etiology is not simple. In the last consensus conference of the Barany Society (2014) the classification of VAS into three types was not sufficient to distinguish "benign" vertigo from "risky" dizziness (related to a central cause).

status: Active, not recruiting

ReferenceCitation: Tarnutzer AA, Berkowitz AL, Robinson KA, Hsieh YH, Newman-Toker DE. Does my dizzy patient have a stroke? A systematic review of bedside diagnosis in acute vestibular syndrome. CMAJ. 2011 Jun 14;183(9):E571-92. doi: 10.1503/cmaj.100174. Epub 2011 May 16. Review.

ReferenceCitation: Kerber KA, Meurer WJ, Brown DL, Burke JF, Hofer TP, Tsodikov A, Hoeffner EG, Fendrick AM, Adelman EE, Morgenstern LB. Stroke risk stratification in acute dizziness presentations: A prospective imaging-based study. Neurology. 2015 Nov 24;85(21):1869-78. doi: 10.1212/WNL.0000000000002141. Epub 2015 Oct 28.

ReferenceCitation: Kene MV, Ballard DW, Vinson DR, Rauchwerger AS, Iskin HR, Kim AS. Emergency Physician Attitudes, Preferences, and Risk Tolerance for Stroke as a Potential Cause of Dizziness Symptoms. West J Emerg Med. 2015 Sep;16(5):768-76. doi: 10.5811/westjem.2015.7.26158. Epub 2015 Oct 20.

ReferenceCitation: Kattah JC, Talkad AV, Wang DZ, Hsieh YH, Newman-Toker DE. HINTS to diagnose stroke in the acute vestibular syndrome: three-step bedside oculomotor examination more sensitive than early MRI diffusion-weighted imaging. Stroke. 2009 Nov;40(11):3504-10. doi: 10.1161/STROKEAHA.109.551234. Epub 2009 Sep 17.

ReferenceCitation: Newman-Toker DE, Kerber KA, Hsieh YH, Pula JH, Omron R, Saber Tehrani AS, Mantokoudis G, Hanley DF, Zee DS, Kattah JC. HINTS outperforms ABCD2 to screen for stroke in acute continuous vertigo and dizziness. Acad Emerg Med. 2013 Oct;20(10):986-96. doi: 10.1111/acem.12223.

ReferenceCitation: Becares-Martinez C, Lopez-Llames A, Arroyo-Domingo MM, Marco-Algarra J, Morales Suarez-Varela MM. [What do MRI and CT scan provide us in patients with vertigo and dizziness? A cost-utility analysis]. Rev Neurol. 2019 Apr 16;68(8):326-332. doi: 10.33588/rn.6808.2018399. Spanish.

ReferenceCitation: Dumitrascu OM, Torbati S, Tighiouart M, Newman-Toker DE, Song SS. Pitfalls and Rewards for Implementing Ocular Motor Testing in Acute Vestibular Syndrome: A Pilot Project. Neurologist. 2017 Mar;22(2):44-47. doi: 10.1097/NRL.0000000000000106.

ReferenceCitation: Vanni S, Nazerian P, Casati C, Moroni F, Risso M, Ottaviani M, Pecci R, Pepe G, Vannucchi P, Grifoni S. Can emergency physicians accurately and reliably assess acute vertigo in the emergency department? Emerg Med Australas. 2015 Apr;27(2):126-31. doi: 10.1111/1742-6723.12372. Epub 2015 Mar 10.


title: Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.

acronym: DEEP

summary:
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion).

Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.

Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.

lead_sponsor: ISIS Diabete Service


title: Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

acronym: ALLOPIV

summary: Bronchiolitis obliterans (BO) is the well-known manifestation of the chronic pulmonary graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). The pathophysiology of BO is, however, poorly known. The available data strongly support the role of respiratory viruses, in particular paramyxoviruses (parainfluenzae virus (PIV), respiratory syncytial virus, metapneumovirus). It is likely that the alloimmune response triggered by the respiratory virus is inadequate and leads to the peribronchiolar fibrotic process. The objective is to analyze the kinetics of profiles of the blood and respiratory host responses resulting from a high or low parainfluenza respiratory infection, in order to evaluate if the occurrence of a BO is associated with a specific signature We will evaluate the predictive signature of a BO after a parainfluenza virus infection by characterizing the differences between the patients evolving and those not evolving to a BO at 2 months after the infection.


title: Bioavailability of Protein and Amino Acids of Pea Protein Isolate in Healthy Volunteers

acronym: Qualipois

summary:
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of pea protein isolate and casein isolate. For this purpose, the investigators will compare two methods:

the standard method consisting in measuring the ileal digestibility using ileal tubes,
an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Guillin FM, Gaudichon C, Guérin-Deremaux L, Lefranc-Millot C, Airinei G, Khodorova N, Benamouzig R, Pomport PH, Martin J, Calvez J. Real ileal amino acid digestibility of pea protein compared to casein in healthy humans, a randomized trial. Am J Clin Nutr. 2021 Oct 19. pii: nqab354. doi: 10.1093/ajcn/nqab354. [Epub ahead of print]

journal_name: The American Journal of Clinical Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: OUP accepted manuscript

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche sur Volontaires (CRV)

intervention_type: Dietary Supplement


title: Bioavailability of Protein and Amino Acids From Oilseeds in Healthy Volunteers

acronym: PRODIGE

summary:
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of 4 protein sources: sunflower, rapeseed, lupin, flax. For this purpose, the investigators will compare two methods:

the standard method consisting in measuring the ileal digestibility using ileal tubes
an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method

location_facility: Centre de Recherche sur Volontaires (CRV), Hospital Avicenne


title: Validity of Using Connected Soles In Measuring Steps Number In the Older Subject, Hospitalized in Follow-up and Rehabilitative Care and Achieve Its Rehabilitation Objectives

acronym: SEMCOPAGE

summary: The purpose of this study is to evaluate counting steps by connected soles worn in the shoes of subjects, having recovered the maximum walking capacities of patients . To answer the question asked in the study, it is planned to include 60 patients over 70 years of age.

primary_purpose: Device Feasibility

location_facility: Geriatric Department - Paul Brousse Hospital


title: Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy

acronym: DIETADOM

summary: The purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics.

location_facility: Geriactric Departement, Rives de Seine hopsital


title: Assessment of the Relevance of a Medico-social Care of Elderly Patients, in Relay Between Hospital and Home: Experimentation of TEMPORARY HERBERGEMENT in Retirement Home " EHPAD " in Seine-et-Marne Department

summary: The main objective is to study the impact of Temporary Hebergement (TH), as a medico-social care link between hospital and home, on the length of hospitalization in the referral services.


title: Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study)

acronym: FAMILYVASC

summary: The FAMILYVASC study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. Genetic analysis based on whole exome sequencing will be carried out through salivary DNA.

lead_sponsor: Benjamin Terrier

location_facility: Hôpital Cochin - Department of Internal Medicine

intervention_type: Genetic


title: Clinical Impact of Rapid Susceptibility Testing on MHR-SIR Directly From Blood Cultures

acronym: MHR-BC

summary:
Bacteremia is defined as pathogenic bacteria presence in blood as evidenced by positive blood cultures. These bacteremia have significant consequences in terms of morbidity and mortality (ref. 1,2,3). They can lead to a state of septic shock that is life-threatening for the patient and must be treated as a matter of urgency. Any delay in treatment is detrimental to the patient. Management is based on prescription of probabilistic antibiotic therapy as soon as bacteremia is suspected.

At the Groupe Hospitalier Paris Saint Joseph (GHPSJ), as soon as a blood culture is known to be positive, the Mobile Clinical Microbiology Unit (UMMC) is notified in real time. The UMMC infectiologist, in consultation with the microbiologist, evaluates microbiological data and compares them with clinical data in order to prescribe probabilistic antibiotic therapy in the patient's bed. The possible adaptation of antibiotic treatment then depends on the results of antibiotic susceptibility test.

Early adaptation of antibiotic treatment to antibiotic susceptibility data, to reassess ineffective treatment or to reduce antibiotic therapy spectrum, significantly improves patient prognosis: it is therefore important that the laboratory makes antibiotic susceptibility test results available to the clinician as early as possible.

ReferenceCitation: Périllaud C, Pilmis B, Diep J, Péan de Ponfilly G, Vidal B, Couzigou C, Mizrahi A, Lourtet-Hascoët J, Le Monnier A, Nguyen Van JC. Prospective evaluation of rapid antimicrobial susceptibility testing by disk diffusion on Mueller-Hinton rapid-SIR directly on blood cultures. Diagn Microbiol Infect Dis. 2019 Jan;93(1):14-21. doi: 10.1016/j.diagmicrobio.2018.07.016. Epub 2018 Jul 31.

ReferenceCitation: Garnacho-Montero J, Gutiérrez-Pizarraya A, Escoresca-Ortega A, Fernández-Delgado E, López-Sánchez JM. Adequate antibiotic therapy prior to ICU admission in patients with severe sepsis and septic shock reduces hospital mortality. Crit Care. 2015 Aug 27;19:302. doi: 10.1186/s13054-015-1000-z.

ReferenceCitation: Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Régnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.

ReferenceCitation: Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.


title: Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device

acronym: SSIADR

summary: The main purpose is to study, in comparison to classic Home Nursing Care Services (SSIAD), the effect of reinforced Home Nursing Care Services (SSIAD) on the occurrence of hospitalizations


title: Measuring the Impact of Care in the Cognitive Behavioural Unit

acronym: IMPACTUCC

summary: The purpose of this study is to compare the rate of re-hospitalizations in relation to a disruptive behaviour disorder (at 3 and 6 months) between patients who have received care in Cognitive Behavioural Unity (UCC ) and those who have received care in Geriatric Follow-up and Rehabilitation Care Unit (SSR).

location_facility: Psychiatric Geriatric Department, Bretonneau hospital


title: Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted Physical Activity for Malnourished, or at Risk of Undernutrition, Elderly People on Discharge From Hospital

acronym: NUTRIACTIF

summary: In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Muscle loss due to inadequate dietary intake, hypermetabolism and immobilization results in the onset or worsening of mobility disorders and functional decline. After hospitalization, 30-50% of elderly people hospitalized in emergency in medical departments have lost autonomy in daily life. Nutritional management and adaptive physical activity (APA) could have synergistic action to improve the nutritional status and mobility of elderly patients. The short duration of the average stay the acute geriatric units (10-15 days) is not enough to renew, nor to re-educate patients. It seems important to continue these actions at home. The implementation of programs combining nutrition and adapted physical activity (APA) at the hospital exit has not been studied to date. We formulate the hypothesis that in elderly people who are malnourished or at risk of undernutrition, after hospitalization, a personalized home intervention combining nutritional advice and appropriate physical activity will limit their loss of autonomy.

location_facility: Département de Gériatrie, Hôpital Bichat


title: Learning Process of Fifth Years Medical Students During a Psychiatric Role Play : a Mixed Method Study

summary:
This study aims to explore learning process in a role play for undergraduate students working on psychiatric interview. This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry. The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context

Methodology: Mixed method study with:

Quantitative features:

Self-reported questionnaries : " Learning Effectiveness Inventory Scale "
Sociodemographical data and others questions

Qualitative : Grounded Theory

Semi-structured interview of learners and teachers
Record of simulation and audio-record and briefing and debriefing (supplemented by quotation with conversational analysis (Rotterdam Interaction Analysis System, RIAS) for video)

lead_sponsor: Institut Mutualiste Montsouris


title: Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes

acronym: DIAPASON

summary: The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)

time_perspective: Other


title: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home

acronym: KitPA

summary: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city


title: Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture

acronym: OPTIVERT

summary:
The management of osteoporotic fractures has recently changed with the emergence of new programs dedicated to the diagnosis and treatment of osteoporosis. For example, the Fracture Network of the Paris Saint-Joseph Hospital Group, created in 2015, identifies and ensures the care of patients who have consulted emergency rooms for osteoporotic fractures. Within this sector, the vertebral fracture (VF) appears to be the most frequent (22.4%) ahead of other fracture sites, confirming the results of other studies that consider VF as a real public health problem.

Osteoporotic vertebral fractures (OVF) have certain specificities compared to other osteoporotic fractures, encouraging particular interest.

ReferenceCitation: Ballane G, Cauley JA, Luckey MM, El-Hajj Fuleihan G. Worldwide prevalence and incidence of osteoporotic vertebral fractures. Osteoporos Int. 2017 May;28(5):1531-1542. doi: 10.1007/s00198-017-3909-3. Epub 2017 Feb 6. Review.

family: Ballane

full_name: G. Ballane

given: G.

family: Cauley

full_name: J. A. Cauley

given: J. A.

family: Luckey

full_name: M. M. Luckey

given: M. M.

family: El-Hajj Fuleihan

full_name: G. El-Hajj Fuleihan

journal_name: Osteoporosis International

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Venmans A, Lohle PN, van Rooij WJ. Pain course in conservatively treated patients with back pain and a VCF on the spine radiograph (VERTOS III). Skeletal Radiol. 2014 Jan;43(1):13-8. doi: 10.1007/s00256-013-1729-x. Epub 2013 Oct 8.

family: Venmans

full_name: Alexander Venmans

given: Alexander

family: Lohle

full_name: P. N. M. Lohle

given: P. N. M.

family: van Rooij

full_name: W. J. van Rooij

given: W. J.

journal_name: Skeletal Radiology

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Jung HJ, Park YS, Seo HY, Lee JC, An KC, Kim JH, Shin BJ, Kang TW, Park SY. Quality of Life in Patients with Osteoporotic Vertebral Compression Fractures. J Bone Metab. 2017 Aug;24(3):187-196. doi: 10.11005/jbm.2017.24.3.187. Epub 2017 Aug 31.

name: Department of Orthopaedic Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.

family: Jung

full_name: Ho Jin Jung

given: Ho Jin

name: Department of Orthopaedic Surgery, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.

family: Park

full_name: Ye-Soo Park

given: Ye-Soo

name: Department of Orthopaedic Surgery, Chonnam National University Hospital, Gwangju, Korea.

family: Seo

full_name: Hyoung-Yeon Seo

given: Hyoung-Yeon

name: Department of Orthopaedic Surgery, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.

family: Lee

full_name: Jae-Chul Lee

given: Jae-Chul

name: Department of Orthopaedic Surgery, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.

family: An

full_name: Ki-Chan An

given: Ki-Chan

name: Department of Orthopaedic Surgery, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.

family: Kim

full_name: Jin-Hyok Kim

given: Jin-Hyok

family: Shin

full_name: Byung-Joon Shin

given: Byung-Joon

family: Kang

full_name: Tae Wook Kang

given: Tae Wook

full_name: Si Young Park

given: Si Young

journal_name: Journal of Bone Metabolism

oa_host_type: repository

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

host_type: repository

ReferenceCitation: Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Liberman U, Minne H, Reeve J, Reginster JY, de Vernejoul MC, Wiklund I. Quality of life as outcome in the treatment of osteoporosis: the development of a questionnaire for quality of life by the European Foundation for Osteoporosis. Osteoporos Int. 1997;7(1):36-8.

ReferenceCitation: Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3.

ReferenceCitation: Li L, Ren J, Liu J, Wang H, Wang X, Liu Z, Sun T. Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials. PLoS One. 2015 Sep 17;10(9):e0138126. doi: 10.1371/journal.pone.0138126. eCollection 2015.

ReferenceCitation: Carlier RY, Gordji H, Mompoint DM, Vernhet N, Feydy A, Vallée C. Osteoporotic vertebral collapse: percutaneous vertebroplasty and local kyphosis correction. Radiology. 2004 Dec;233(3):891-8. Epub 2004 Oct 14.

ReferenceCitation: Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017 Mar;40(3):331-342. doi: 10.1007/s00270-017-1574-8. Epub 2017 Jan 19.

journal_name: CardioVascular and Interventional Radiology

ReferenceCitation: Ibrahim A, Singh DKA, Shahar S. 'Timed Up and Go' test: Age, gender and cognitive impairment stratified normative values of older adults. PLoS One. 2017 Oct 3;12(10):e0185641. doi: 10.1371/journal.pone.0185641. eCollection 2017.

title: ‘Timed Up and Go’ test: Age, gender and cognitive impairment stratified normative values of older adults

ReferenceCitation: Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993 Sep;8(9):1137-48.


title: Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma

acronym: imMUno

summary: Study of the activity of PD-1 inhibitors in metastatic uveal melanoma

time_perspective: Cross-Sectional

lead_sponsor: Institut Curie


title: Multicenter Evaluation of the Susceptibility of Enterobacteriaceae and Pseudomonas Aeruginosa to Ceftolozane/Tazobactam Combination

summary: Ceftolozane/tazobactam is a new antibiotic with broad spectrum activity. This molecule is currently one of the most active beta lactams against Pseudomonas aeruginosa and its spectrum of activity also includes enterobacteriaceae producing a broad spectrum beta-lactamase (EBLSE). Ceftolozane/tazobactam is currently marketed for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. These intra-abdominal and urinary infections are mainly caused by enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and more rarely by P. aeruginosa. Concerning enterobacteriaceae, French epidemiology reports a prevalence of BLSE of between 10 and 15% in E. coli and 10%-30% in K. pneumoniae.

ReferenceCitation: Castanheira M, Duncan LR, Mendes RE, Sader HS, Shortridge D. Activity of Ceftolozane-Tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae Isolates Collected from Respiratory Tract Specimens of Hospitalized Patients in the United States during 2013 to 2015. Antimicrob Agents Chemother. 2018 Feb 23;62(3). pii: e02125-17. doi: 10.1128/AAC.02125-17. Print 2018 Mar.

name: JMI Laboratories, North Liberty, Iowa, USA

family: Castanheira

full_name: Mariana Castanheira

given: Mariana

family: Duncan

full_name: Leonard R. Duncan

given: Leonard R.

family: Mendes

full_name: Rodrigo E. Mendes

given: Rodrigo E.

family: Sader

full_name: Helio S. Sader

given: Helio S.

family: Shortridge

full_name: Dee Shortridge

given: Dee

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Walkty A, Adam H, Baxter M, Lagacé-Wiens P, Karlowsky JA, Hoban DJ, Zhanel GG. In vitro activity of ceftolozane/tazobactam versus antimicrobial non-susceptible Pseudomonas aeruginosa clinical isolates including MDR and XDR isolates obtained from across Canada as part of the CANWARD study, 2008-16. J Antimicrob Chemother. 2018 Mar 1;73(3):703-708. doi: 10.1093/jac/dkx468.

name: Department of Internal Medicine, Section of Infectious Diseases, University of Manitoba, Winnipeg, Manitoba, Canada

name: Diagnostic Services Manitoba, Winnipeg, Manitoba, Canada

family: Walkty

full_name: Andrew Walkty

given: Andrew

name: Department of Medical Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, Manitoba, Canada

family: Adam

full_name: Heather Adam

given: Heather

family: Baxter

full_name: Melanie Baxter

given: Melanie

family: Lagacé-Wiens

full_name: Philippe Lagacé-Wiens

given: Philippe

family: Karlowsky

full_name: James A Karlowsky

given: James A

family: Hoban

full_name: Daryl J Hoban

given: Daryl J

family: Zhanel

full_name: George G Zhanel

given: George G

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

title: In vitro activity of ceftolozane/tazobactam versus antimicrobial non-susceptible Pseudomonas aeruginosa clinical isolates including MDR and XDR isolates obtained from across Canada as part of the CANWARD study, 2008–16

ReferenceCitation: Monogue ML, Nicolau DP. Antibacterial activity of ceftolozane/tazobactam alone and in combination with other antimicrobial agents against MDR Pseudomonas aeruginosa. J Antimicrob Chemother. 2018 Apr 1;73(4):942-952. doi: 10.1093/jac/dkx483.

name: Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, USA

family: Monogue

full_name: Marguerite L Monogue

given: Marguerite L

name: Division of Infectious Diseases, Hartford Hospital, Hartford, CT, USA

ReferenceCitation: Munita JM, Aitken SL, Miller WR, Perez F, Rosa R, Shimose LA, Lichtenberger PN, Abbo LM, Jain R, Nigo M, Wanger A, Araos R, Tran TT, Adachi J, Rakita R, Shelburne S, Bonomo RA, Arias CA. Multicenter Evaluation of Ceftolozane/Tazobactam for Serious Infections Caused by Carbapenem-Resistant Pseudomonas aeruginosa. Clin Infect Dis. 2017 Jul 1;65(1):158-161. doi: 10.1093/cid/cix014.

name: Center for Antimicrobial Resistance and Microbial Genomics and Gulf Coast Consortium on Antimicrobial Resistance,

name: Division of Infectious Diseases, Department of Internal Medicine, and

name: Genomics and Resistant Microbes Group, Clinica Alemana, Universidad del Desarrollo, Santiago, Chile;

name: Cleveland Veterans Affairs Medical Center Case Western Reserve University, Ohio,

name: Department of Medicine, Jackson Memorial Hospital and

name: Division of Infectious Diseases, University of Miami Miller School of Medicine, Florida,

name: Department of Pathology and Laboratory Medicine, University of Texas McGovern Medical School, Houston;

name: Infectious Diseases, Infection Control and Employee Health, University of Texas MD Anderson Cancer Center, Houston,

name: Division of Allergy and Infectious Diseases, University of Washington, Seattle; and

name: International Center for Antimicrobial Resistance, Universidad El Bosque, Bogota, Colombia

ReferenceCitation: Chen M, Zhang M, Huang P, Lin Q, Sun C, Zeng H, Deng Y. Novel β-lactam/β-lactamase inhibitors versus alternative antibiotics for the treatment of complicated intra-abdominal infection and complicated urinary tract infection: a meta-analysis of randomized controlled trials. Expert Rev Anti Infect Ther. 2018 Feb;16(2):111-120. doi: 10.1080/14787210.2018.1429912. Epub 2018 Jan 24. Review.

name: Department of Critical Care Medicine and Emergency, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, PR China

name: Shantou University Medical College, Shantou, Guangdong, PR China

name: Department of Critical Care Medicine, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, PR China


title: Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care

acronym: ARVACC

summary: This study compares Virtual Reality versus Nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.

ReferenceCitation: Laghlam D, Naudin C, Coroyer L, Aidan V, Malvy J, Rahoual G, Estagnasié P, Squara P. Virtual reality vs. Kalinox® for management of pain in intensive care unit after cardiac surgery: a randomized study. Ann Intensive Care. 2021 May 13;11(1):74. doi: 10.1186/s13613-021-00866-w.

family: Laghlam

full_name: Driss Laghlam

given: Driss

family: Naudin

full_name: Cecile Naudin

given: Cecile

family: Coroyer

full_name: Lucas Coroyer

given: Lucas

family: Aidan

full_name: Vincent Aidan

given: Vincent

family: Malvy

full_name: Julien Malvy

given: Julien

family: Rahoual

full_name: Ghilas Rahoual

given: Ghilas

family: Estagnasié

full_name: Philippe Estagnasié

family: Squara

full_name: Pierre Squara

given: Pierre

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by


title: OPTICONCIL: Implementation of Medication Reconciliation Process in an Emergency Department : Which Patients Should be Prioritized and How to Optimize Patients' Therapeutics?

summary:
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients.

This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.


title: Interest of the Return to Primary Care of the "Low Back Booklet" of Health Insurance in the Recovery of Common Acute Low Back Pain

summary:
Low back pain is defined as pain or functional discomfort between the twelfth rib and the gluteal fold, which may be median or lateralised. It can radiate up to the thigh but never below the knee. Low back pain is said to be acute if it has been progressing for less than three months. In the acute form, it evolves on a mechanical rhythm, prevents the usual activity and occurs preferably in adults aged 20 to 55 years. 90% of these low back pains are mechanical and common, i.e. characterized by the absence of "red flags ". The red flags refer to a group of characteristic clinical signs that should alert the practitioner to the possibility of an underlying serious spinal pathology and the need for further investigation.

Common low back pain is a public health issue since it is the leading cause of health expenditure in Europe and an economic challenge (900 million euros / year and 19.1% of work stoppages in 2015 compared to 13% in 2005).

In 80% of cases, the general practitioner is in the first line of care in cases of acute low back pain. Indeed, it represents a frequent reason for consultation in general medicine (2nd reason for consultation among general practitioners in 2015).

The doctor must: track down warning signs that call into question the diagnosis of common low back pain (red flags), relieve and reassure the patient. Common low back pain very often heals spontaneously but about 10% of patients will develop chronic low back pain (persistence of pain for more than 3 months). These chronicized patients account for 80% of the total cost of low back pain.

ReferenceCitation: Greenhalgh S, Selfe J. A qualitative investigation of Red Flags for serious spinal pathology. Physiotherapy. 2009 Sep;95(3):224-7. doi: 10.1016/j.physio.2009.04.006. Epub 2009 Jul 8.

family: Greenhalgh

full_name: S. Greenhalgh

given: S.

family: Selfe

full_name: J. Selfe

given: J.

journal_name: Physiotherapy

ReferenceCitation: Nicholas MK, Linton SJ, Watson PJ, Main CJ; "Decade of the Flags" Working Group. Early identification and management of psychological risk factors ("yellow flags") in patients with low back pain: a reappraisal. Phys Ther. 2011 May;91(5):737-53. doi: 10.2522/ptj.20100224. Epub 2011 Mar 30. Review.

family: Nicholas

full_name: Michael K. Nicholas

given: Michael K.

family: Linton

full_name: Steven J. Linton

given: Steven J.

family: Watson

full_name: Paul J. Watson

given: Paul J.

family: Main

full_name: Chris J. Main

given: Chris J.

journal_name: Physical Therapy

title: Early Identification and Management of Psychological Risk Factors (“Yellow Flags”) in Patients With Low Back Pain: A Reappraisal

ReferenceCitation: Bishop A, Foster NE, Thomas E, Hay EM. How does the self-reported clinical management of patients with low back pain relate to the attitudes and beliefs of health care practitioners? A survey of UK general practitioners and physiotherapists. Pain. 2008 Mar;135(1-2):187-95. doi: 10.1016/j.pain.2007.11.010.

family: Bishop

full_name: Annette Bishop

given: Annette

family: Foster

full_name: Nadine E. Foster

given: Nadine E.

family: Thomas

full_name: Elaine Thomas

given: Elaine

family: Hay

full_name: Elaine M. Hay

given: Elaine M.

journal_name: Pain

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Friedman BW, Irizarry E, Solorzano C, Khankel N, Zapata J, Zias E, Gallagher EJ. Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain. Ann Emerg Med. 2017 Aug;70(2):169-176.e1. doi: 10.1016/j.annemergmed.2016.10.002. Epub 2017 Feb 7.

family: Friedman

full_name: Benjamin W. Friedman

given: Benjamin W.

family: Irizarry

ReferenceCitation: Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.

name: Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York

name: Medical College, Albert Einstein College of Medicine, Bronx, New York

name: Pharmacy Department, Montefiore Medical Center, Bronx, New York

ReferenceCitation: Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. [French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Fr. 1993 May;60(5):335-41. French.

ReferenceCitation: Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4.


title: Antiplatelet Resistance Research in Patients With Peripheral Arterial Revascularization

acronym: RAP

summary: In coronary pathology, persistent platelet hyperresponsiveness under antiplatelet therapy, which is often referred to as "antiplatelet resistance," is predictive of increased risk of thrombotic recurrence as well as hyper-Inhibition of this aggregation may be predictive of a hemorrhagic risk. But no study has shown that the adaptation of treatment based on platelet aggregation tests has a benefit: the management of antiplatelet treatments through the search for antiplatelet resistance (APR) is not recommended by the European Society of Cardiology (ESC) in the context of coronary angioplasty (IIIA), while this is a common practice in neurovascular pathology.

ReferenceCitation: Siller-Matula JM, Delle-Karth G, Lang IM, Neunteufl T, Kozinski M, Kubica J, Maurer G, Linkowska K, Grzybowski T, Huber K, Jilma B. Phenotyping vs. genotyping for prediction of clopidogrel efficacy and safety: the PEGASUS-PCI study. J Thromb Haemost. 2012 Apr;10(4):529-42. doi: 10.1111/j.1538-7836.2012.04639.x.

family: SILLER-MATULA

full_name: J. M. SILLER-MATULA

given: J. M.

family: DELLE-KARTH

full_name: G. DELLE-KARTH

given: G.

family: LANG

full_name: I. M. LANG

given: I. M.

family: NEUNTEUFL

full_name: T. NEUNTEUFL

given: T.

family: KOZINSKI

full_name: M. KOZINSKI

given: M.

family: KUBICA

full_name: J. KUBICA

family: MAURER

full_name: G. MAURER

family: LINKOWSKA

full_name: K. LINKOWSKA

given: K.

family: GRZYBOWSKI

full_name: T. GRZYBOWSKI

family: HUBER

full_name: K. HUBER

family: JILMA

full_name: B. JILMA

given: B.

journal_name: Journal of Thrombosis and Haemostasis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Pinto Slottow TL, Bonello L, Gavini R, Beauzile P, Sushinsky SJ, Scheinowitz M, Kaneshige K, Xue Z, Torguson R, Tantry U, Pichard AD, Satler LF, Suddath WO, Kent K, Gurbel P, Waksman R. Prevalence of aspirin and clopidogrel resistance among patients with and without drug-eluting stent thrombosis. Am J Cardiol. 2009 Aug 15;104(4):525-30. doi: 10.1016/j.amjcard.2009.04.015. Epub 2009 Jun 24.

family: Pinto Slottow

full_name: Tina L. Pinto Slottow

given: Tina L.

family: Bonello

full_name: Laurent Bonello

given: Laurent

family: Gavini

full_name: Rekha Gavini

given: Rekha

family: Beauzile

full_name: Patricia Beauzile

given: Patricia

family: Sushinsky

full_name: Steven J. Sushinsky

family: Scheinowitz

full_name: Mickey Scheinowitz

given: Mickey

family: Kaneshige

full_name: Kimberly Kaneshige

given: Kimberly

family: Xue

full_name: Zhenyi Xue

given: Zhenyi

family: Torguson

title: Prevalence of Aspirin and Clopidogrel Resistance Among Patients With and Without Drug-Eluting Stent Thrombosis

ReferenceCitation: Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Gupta R, Moore JM, Griessenauer CJ, Adeeb N, Patel AS, Youn R, Poliskey K, Thomas AJ, Ogilvy CS. Assessment of Dual-Antiplatelet Regimen for Pipeline Embolization Device Placement: A Survey of Major Academic Neurovascular Centers in the United States. World Neurosurg. 2016 Dec;96:285-292. doi: 10.1016/j.wneu.2016.09.013. Epub 2016 Sep 15.

ReferenceCitation: Mazur P, Frołow M, Niżankowski R, Sadowski J, Undas A. Impaired responsiveness to clopidogrel and aspirin in patients with recurrent stent thrombosis following percutaneous intervention for peripheral artery disease. Platelets. 2013;24(2):151-5. doi: 10.3109/09537104.2012.676220. Epub 2012 Apr 13.

ReferenceCitation: Mueller MR, Salat A, Stangl P, Murabito M, Pulaki S, Boehm D, Koppensteiner R, Ergun E, Mittlboeck M, Schreiner W, Losert U, Wolner E. Variable platelet response to low-dose ASA and the risk of limb deterioration in patients submitted to peripheral arterial angioplasty. Thromb Haemost. 1997 Sep;78(3):1003-7.

ReferenceCitation: Kasotakis G, Pipinos II, Lynch TG. Current evidence and clinical implications of aspirin resistance. J Vasc Surg. 2009 Dec;50(6):1500-10. doi: 10.1016/j.jvs.2009.06.023. Epub 2009 Aug 12. Review.

ReferenceCitation: Doly JS, Lorian E, Desormais I, Constans J, Bura Rivière A, Lacroix P. [Prevalence and prognosis of aspirin resistance in critical limb ischemia patients]. J Mal Vasc. 2016 Dec;41(6):358-364. doi: 10.1016/j.jmv.2016.08.004. Epub 2016 Oct 14. French.

title: Prévalence et valeur pronostique de la résistance à l’aspirine chez les patients en ischémie critique chronique des membres inférieurs

ReferenceCitation: Navarese EP, Wernly B, Lichtenauer M, Petrescu AM, Kołodziejczak M, Lauten A, Frediani L, Veulemanns V, Wanha W, Wojakowski W, Lesiak M, Ferrante G, Zeus T, Tantry U, Bliden K, Buffon A, Contegiacomo G, Jung C, Kubica J, Pestrichella V, Gurbel PA. Dual vs single antiplatelet therapy in patients with lower extremity peripheral artery disease - A meta-analysis. Int J Cardiol. 2018 Oct 15;269:292-297. doi: 10.1016/j.ijcard.2018.07.009. Epub 2018 Jul 3.

title: Dual vs single antiplatelet therapy in patients with lower extremity peripheral artery disease – A meta-analysis

ReferenceCitation: Soden PA, Zettervall SL, Ultee KH, Landon BE, O'Malley AJ, Goodney PP, DeMartino RR, Arya S, Schermerhorn ML; Society for Vascular Surgery Vascular Quality Initiative. Dual antiplatelet therapy is associated with prolonged survival after lower extremity revascularization. J Vasc Surg. 2016 Dec;64(6):1633-1644.e1. doi: 10.1016/j.jvs.2016.05.098. Epub 2016 Aug 27.


acronym: PREDICT-CF

type: EudraCT Number

source: euctr

title: Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. Pathway to Personalized Therapy in Cystic Fibrosis

summary: The purpose of the study is to investigate whether the correction of CFTR function by Lumacaftor/Ivacaftor in a patient-derived primary nasal cell model is a surrogate biomarker for respiratory improvement in Orkambi® treated patients.


acronym: MetPAP

title: Oral or Enteral Administration of Methionine in Patients With Pulmonary Alveolar Proteinosis by Mutation of the MARS Gene.

summary: The purpose of this study is to determine the safety and tolerance of an oral administration of methionine in the treatment of pulmonary alveolar proteinosis due to the double mutation Ala393Thr / Ser567Leu in the MARS gene. This disease is very severe and especially leads to chronic respiratory insufficiency. There is no curative treatment for this disease. The MARS gene encodes the methionine tRNA synthetase (MetRS). Mutations in this gene leads to a defect in MetRS function. In cultured mutated yeast, addition of methionine in culture medium restores MetRS function. Therefore, the investigators hypothesized that treatment of patients with methionine could have beneficial effects on the disease.


title: Non Inferiority Multicenter Phase III Randomized Trial Comparing Preoperative Chemotherapy Only to Chemotherapy Followed by Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer (Intergroup FRENCH-GRECCAR- PRODIGE)

summary:
This study is a non-inferiority phase III randomised trial comparing preoperative chemotherapy alone (modified FOLFIRINOX) to chemotherapy followed by chemoradiotherapy in patients with primary resectable locally advanced rectal cancer. The primary endpoint of the study is 3-year progression free survival.

Expected 3 year PFS rate in the preoperative chemotherapy followed by chemoradiotherapy arm is 75%. This hazard rate, in an exponential survival model, corresponds to a decrease in the 3-year PFS rate on the preoperative chemotherapy arm to 67%. The study will randomize 540 patients (270 in the chemotherapy group and 270 in the chemoradiotherapy group) in 42 french academic centers.

ReferenceCitation: Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. Erratum in: N Engl J Med. 2007 Aug 16;357(7):728.

ReferenceCitation: Wiltink LM, Chen TY, Nout RA, Kranenbarg EM, Fiocco M, Laurberg S, van de Velde CJ, Marijnen CA. Health-related quality of life 14 years after preoperative short-term radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomised trial. Eur J Cancer. 2014 Sep;50(14):2390-8. doi: 10.1016/j.ejca.2014.06.020. Epub 2014 Jul 21.

ReferenceCitation: Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, Reidy-Lagunes DL, Gollub MJ, Shia J, Guillem JG, Temple LK, Paty PB, Saltz LB. Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial. J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13.

ReferenceCitation: Bensignor T, Brouquet A, Dariane C, Thirot-Bidault A, Lazure T, Julié C, Nordlinger B, Penna C, Benoist S. Pathological response of locally advanced rectal cancer to preoperative chemotherapy without pelvic irradiation. Colorectal Dis. 2015 Jun;17(6):491-8. doi: 10.1111/codi.12879.

ReferenceCitation: Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.

ReferenceCitation: Brouquet A, Bachet JB, Huguet F, Karoui M, Artru P, Sabbagh C, Lefèvre JH, Vernerey D, Mariette C, Vicaut E, Benoist S; on behalf the FRENCH , GRECCAR, PRODIGE study groups. NORAD01-GRECCAR16 multicenter phase III non-inferiority randomized trial comparing preoperative modified FOLFIRINOX without irradiation to radiochemotherapy for resectable locally advanced rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE trial). BMC Cancer. 2020 May 29;20(1):485. doi: 10.1186/s12885-020-06968-1.

family: Brouquet

full_name: Antoine Brouquet

given: Antoine

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Huguet

full_name: Florence Huguet

given: Florence

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Artru

full_name: Pascal Artru

given: Pascal

family: Sabbagh

full_name: Charles Sabbagh

given: Charles

family: Lefèvre

full_name: Jérémie H. Lefèvre

given: Jérémie H.

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Benoist

full_name: Stephane Benoist

given: Stephane

journal_name: BMC Cancer


title: The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes

acronym: REVADIAB

summary:
Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density.

A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.


title: Interest of Pan Capsule (Small Bowel and Colon Video Capsule) in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy. Phase A. Feasibility

acronym: IPSILON

summary:
Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are several forms of IBS: IBS-D (with predominant diarrhea), IBS-C (with constipation predominant) and IBS-M (mixed with alternating diarrhea and constipation). In the absence of a diagnostic test to confirm the existence of this syndrome, the diagnosis of IBS is based on clinical criteria (Rome IV criteria). In patients suspected of IBS, especially in patients with diarrhea (IBS-D or IBS-M), a colonoscopy with biopsies is often proposed in addition to biological tests (Complete Blood Count, C-reactive protein, thyroid stimulating hormon and anti-transglutaminase antibodies) by the physician or gastroenterologist to exclude an organic digestive disease such as celiac disease, IBD (Crohn's disease or ulcerative colitis), microscopic colitis or even neoplasia.

The colonoscopy is an invasive exploration and does not allow exploration of the entire small bowel.

The development of capsules allowed the exploration of the small bowel more recently of the colon. The new developed pan-capsule allows evaluation of both small bowel and colon.

The aim of this work is to evaluate in patients younger than 50 years, presenting suspicious digestive symptoms of IBS with diarrhea, the interest of a strategy based on the pan-capsule as an alternative to colonoscopy to eliminate a diagnosis of organic digestive disease (celiac disease, IBD, neoplasia, ..).

ReferenceCitation: Le Pluart D, Sabaté JM, Bouchoucha M, Hercberg S, Benamouzig R, Julia C. Functional gastrointestinal disorders in 35,447 adults and their association with body mass index. Aliment Pharmacol Ther. 2015 Apr;41(8):758-67. doi: 10.1111/apt.13143. Epub 2015 Mar 1.

ReferenceCitation: Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18. pii: S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. [Epub ahead of print]

ReferenceCitation: Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000 Sep;119(3):654-60.

ReferenceCitation: Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9. Review.

ReferenceCitation: Corsetti M, Van Oudenhove L, Tack J. The quest for biomarkers in IBS-where should it lead us? Neurogastroenterol Motil. 2014 Dec;26(12):1669-76. doi: 10.1111/nmo.12475. Review.

ReferenceCitation: Andresen V, Whorwell P, Fortea J, Auzière S. An exploration of the barriers to the confident diagnosis of irritable bowel syndrome: A survey among general practitioners, gastroenterologists and experts in five European countries. United European Gastroenterol J. 2015 Feb;3(1):39-52. doi: 10.1177/2050640614558344.

ReferenceCitation: Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Therap Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230. Review.

ReferenceCitation: Spiller R, Camilleri M, Longstreth GF. Do the symptom-based, Rome criteria of irritable bowel syndrome lead to better diagnosis and treatment outcomes? Clin Gastroenterol Hepatol. 2010 Feb;8(2):125-9; discussion 129-36. doi: 10.1016/j.cgh.2009.12.018.

ReferenceCitation: Lieberman DA, Holub J, Eisen G, Kraemer D, Morris CD. Utilization of colonoscopy in the United States: results from a national consortium. Gastrointest Endosc. 2005 Dec;62(6):875-83.

ReferenceCitation: Chey WD, Nojkov B, Rubenstein JH, Dobhan RR, Greenson JK, Cash BD. The yield of colonoscopy in patients with non-constipated irritable bowel syndrome: results from a prospective, controlled US trial. Am J Gastroenterol. 2010 Apr;105(4):859-65. doi: 10.1038/ajg.2010.55. Epub 2010 Feb 23.

ReferenceCitation: Ishihara S, Yashima K, Kushiyama Y, Izumi A, Kawashima K, Fujishiro H, Kojo H, Komazawa Y, Hamamoto T, Yamamoto T, Sasaki Y, Shimizu T, Okamoto E, Yoshimura T, Furuta K, Noguchi N, Tanaka H, Murawaki Y, Kinoshita Y. Prevalence of organic colonic lesions in patients meeting Rome III criteria for diagnosis of IBS: a prospective multi-center study utilizing colonoscopy. J Gastroenterol. 2012 Oct;47(10):1084-90. doi: 10.1007/s00535-012-0573-4. Epub 2012 Mar 30.

ReferenceCitation: Patel P, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P, Ford AC. Prevalence of organic disease at colonoscopy in patients with symptoms compatible with irritable bowel syndrome: cross-sectional survey. Scand J Gastroenterol. 2015 Jul;50(7):816-23. doi: 10.3109/00365521.2015.1007079. Epub 2015 Jan 30.

lead_sponsor: Hospital Avicenne


title: Representations and Strategies of Families Faced With Radicalisation Process of Their Young People

acronym: FamRad

summary:
Objectives:

This study aims to explore families' representations and strategies about their teenagers or young adults involved in the radicalisation process and use these findings to build specific tools to help professionals provide family support.

location_facility: Adolescents House, Universitary Hospital Cochin


title: Usefulness of a Multiplex Polymerase Chain Reaction (mPCR) Assay for the Diagnosis of Postoperative Pneumonia After Thoracic Surgery

acronym: POP-PCR

summary:
Background: In thoracic surgery, postoperative pneumonia (POP) is the leading cause of postoperative morbidity and mortality. The clinical diagnosis of POP is difficult and conventional microbiological diagnostic tests perform poorly. The contribution of molecular diagnostic tests (multiplex PCR, mPCR) should be evaluated to optimize the diagnostic and therapeutic management of POP.

Objectives: The main objective is to describe the microbiological relationship between the existence of pre- (if available) and intra-operative bronchial and pulmonary bacterial colonization and the occurrence of POP. The secondary objectives are to analyze the contribution of the mPCR for the diagnosis of POP and to validate the predictive factors of POP described in the literature Material and methods: A monocentric prospective non-interventional research with minimal risks and constraints. The study population is represented by all the consecutive adult patients hospitalized for lung surgical resection (except surgical resection indicated for infectious disease) during one year. The preoperative respiratory samples within the 3 preceding months (date and type, pathogen and threshold) are recorded, if available. Intra-operative bronchial aspirate is performed for direct examination and culture (pathogen and threshold) and mPCR (PCR1). A mPCR is optionally performed on the surgical specimen (PCR2). In case of postoperative clinical suspicion of POP, invasive or non invasive samples of respiratory tract secretions are obtained for direct examination and culture (pathogen, threshold) and mPCR (PCR3). A clinical pulmonary infection score (CPIS) is calculated by integrating the results of conventional tests (CPIS1) and mPCR (CPIS2).

The pre / intra operative and postoperative microbiological relationship will be described qualitatively and quantitatively and analyzed using correlation tests. Concordances and discrepancies between conventional tests and mPCR will be studied to analyze the contribution of molecular tests in this context.

ipd_sharing_description: individual participant data collected in this study will be used for publication.

location_facility: Service de Réanimation et USC médico-chirurgicale Hôpital Tenon, AP-HP


title: Fertility Preservation in Case of Endometriosis : Observational Cohort Study

acronym: PREFENDO

summary:
Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.

We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.

location_facility: Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON


ReferenceCitation: Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquière C, Luka M, Waldmann T, Vistarini N, Aubert S, Ménager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.

family: Bloc

full_name: Sébastien Bloc

given: Sébastien

family: Perot

full_name: Brieuc P Perot

given: Brieuc P

family: Gibert

full_name: Hadrien Gibert

given: Hadrien

family: Law Koune

full_name: Jean-Dominique Law Koune

given: Jean-Dominique

family: Burg

full_name: Yannick Burg

given: Yannick

family: Leclerc

full_name: Didier Leclerc

given: Didier

family: Vuitton

full_name: Anne-Sophie Vuitton

given: Anne-Sophie

family: De La Jonquière

full_name: Christophe De La Jonquière

family: Luka

full_name: Marine Luka

given: Marine

family: Waldmann

full_name: Thierry Waldmann

given: Thierry

family: Vistarini

full_name: Nicolas Vistarini

given: Nicolas

family: Aubert

full_name: Stéphane Aubert

given: Stéphane

family: Ménager

full_name: Mickaël M Ménager

given: Mickaël M

family: Merzoug

full_name: Messaouda Merzoug

given: Messaouda

family: Naudin

full_name: Cécile Naudin

given: Cécile

family: Squara

full_name: Pierre Squara

given: Pierre

journal_name: Regional Anesthesia & Pain Medicine

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

acronym: PARA

title: Interest of Parasternal Block to Limit the Doses of Anesthetics Necessary for the Maintenance of Arterial Blood Pressure and Heart Rate in the Recommended Values During Sternotomy in Patients Undergoing Coronary Artery Bypass Graft

summary:
Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia.

During cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. Usually these episodes are controlled by the administration of a high-dose of anesthetic agents.

The parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. It allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface.

The preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.


title: Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate

acronym: PROABIS

summary:
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB therapy duration in neonates with LOS.

Our hypothesis is that the use of procalcitonin guidance can reduce of 30% the duration of ATB treatment without increasing recurrence of infection and mortality.

location_facility: Pôle de périnatalité Service de néonatologie


title: Contribution of Thermal Imaging in Determining the Depth of Pediatric Acute Burns: a Prospective Observational Study

acronym: FLIRPED

summary:
The need to cover a burn with a skin graft is determined primarily by its depth. In fact only burns of the second deep degree or the third degree are likely to be grafted. However, if the diagnosis is obvious in the case of third degree burns, second degree burns are often "mixed" with more or less deep areas, especially in pediatrics.

Clinical experience and daily observation of the burn since its occurrence currently determine the indication for surgery. In practice, it is rare to be able to determine with certainty whether a second degree mixed burn will require a graft before the 10-12th day of evolution. There are currently devices that can help refine the diagnosis such as laser Doppler, but they are expensive devices, and not 100% reliable. The thermal camera Flir-one® attaches to a smartphone or tablet and allows thanks to a free application, to obtain a thermogram of the pointed area. This is a device used to detect insulation deficits in the building sector. Knowing that a deep burn, by devascularization, will have an external temperature lower than a superficial burn, a thermogram would thus make it possible to better identify the deep zones and the superficial zones of the burn. One study showed a good sensitivity and specificity of the device but it was a population of adult patients. This determined that a difference in skin temperature between a deep burned area and healthy skin should be at least 1.15 ° C in favor of healthy skin, to retain a burn as deep, and not to operate so-called superficial burn if this difference was below this threshold. However, further studies would be needed to demonstrate the validity of this method in clinical practice.

location_facility: Service de chirurgie plastique et des brûlés


title: Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients

acronym: SPi-REG

summary: Phrenic nerve stimulation is a neurostimulation technique that allows patients who are dependent on external mechanical ventilatory support to regain their breathing autonomy. This study aim at long term following of patients who may be candidates for permanent implanted phrenic nerve stimulator.


title: Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play

acronym: ALIJEU

summary: The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.

lead_sponsor: Centre Hospitalier Intercommunal Creteil