title: Randomized Crossover Trial Comparing Shoulder Abduction Movements, Manual Dexterity and Satisfaction of Transradial Amputees Using Axon-Hook and Greifer Myoelectric Hooks.

summary: Upper limb amputees often report musculoskeletal pain due to exaggerated shoulder abduction movements. Previous studies on prosthetic hands showed that wrist orientation contributes to reduce shoulder compensatory movements. The hypothesis of this research is that prosthetic hooks may also provide better functional outcomes when offering wrist adjustments and a design that favors a good visualization of the grips. The objective of this study is to compare shoulder abduction, manual dexterity and satisfaction when using Axon-Hook and Greifer myoelectric hooks during repetitive tasks. Shoulder abduction and manual dexterity results are also compared with the sound side.

ReferenceCitation: A.G. Cutti; I. Parel; M. Luchetti; E. Gruppioni; N. Rossi; G. Verni, The Psychosocial and Biomechanical Assessment of Amputees Fitted with Commercial Multi-grip Prosthetic Hands, in: Grasping the Future: Advances in Powered Upper Limb Prosthetics, BOLOGNA, VINCENZO PARENTI CASTELLI & MARCO TRONCOSSI, 2012, pp. 59 - 77

ReferenceCitation: Major MJ, Stine RL, Heckathorne CW, Fatone S, Gard SA. Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks. J Neuroeng Rehabil. 2014 Sep 6;11:132. doi: 10.1186/1743-0003-11-132.

ReferenceCitation: Carey SL, Dubey RV, Bauer GS, Highsmith MJ. Kinematic comparison of myoelectric and body powered prostheses while performing common activities. Prosthet Orthot Int. 2009 Jun;33(2):179-86. doi: 10.1080/03093640802613229.

ReferenceCitation: Metzger AJ, Dromerick AW, Holley RJ, Lum PS. Characterization of compensatory trunk movements during prosthetic upper limb reaching tasks. Arch Phys Med Rehabil. 2012 Nov;93(11):2029-34. doi: 10.1016/j.apmr.2012.03.011. Epub 2012 Mar 23.

ReferenceCitation: Ostlie K, Franklin RJ, Skjeldal OH, Skrondal A, Magnus P. Musculoskeletal pain and overuse syndromes in adult acquired major upper-limb amputees. Arch Phys Med Rehabil. 2011 Dec;92(12):1967-1973.e1. doi: 10.1016/j.apmr.2011.06.026.

ReferenceCitation: Bertels T, Schmalz T, Ludwigs E. Objectifying the functional advantages of prosthetic wrist flexion. J Prosthet Orthot. 2009;21(2):74-8.

ReferenceCitation: Deijs M, Bongers RM, Ringeling-van Leusen ND, van der Sluis CK. Flexible and static wrist units in upper limb prosthesis users: functionality scores, user satisfaction and compensatory movements. J Neuroeng Rehabil. 2016 Mar 15;13:26. doi: 10.1186/s12984-016-0130-0.

ReferenceCitation: Resnik L, Borgia M, reliability and validity of outcome measures for upper limb amputation. JPO. 2012;24:192-201

ReferenceCitation: Hebert JS, Lewicke J, Williams TR, Vette AH. Normative data for modified Box and Blocks test measuring upper-limb function via motion capture. J Rehabil Res Dev. 2014;51(6):918-32. doi: 10.1682/JRRD.2013.10.0228.

ReferenceCitation: Haverkate L, Smit G, Plettenburg DH. Assessment of body-powered upper limb prostheses by able-bodied subjects, using the Box and Blocks Test and the Nine-Hole Peg Test. Prosthet Orthot Int. 2016 Feb;40(1):109-16. doi: 10.1177/0309364614554030. Epub 2014 Oct 21.

ReferenceCitation: Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

ReferenceCitation: Carey SL, Jason Highsmith M, Maitland ME, Dubey RV. Compensatory movements of transradial prosthesis users during common tasks. Clin Biomech (Bristol, Avon). 2008 Nov;23(9):1128-35. doi: 10.1016/j.clinbiomech.2008.05.008.

ReferenceCitation: Bouwsema H, van der Sluis CK, Bongers RM. Movement characteristics of upper extremity prostheses during basic goal-directed tasks. Clin Biomech (Bristol, Avon). 2010 Jul;25(6):523-9. doi: 10.1016/j.clinbiomech.2010.02.011. Epub 2010 Apr 1.

ReferenceCitation: Loiret I, Paysant J, Martinet N, Andre JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. doi: 10.1016/j.annrmp.2005.03.009. Epub 2005 Apr 15. French.

ReferenceCitation: Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. doi: 10.1080/10400435.1996.10132268.

ReferenceCitation: Miller LA, Stubblefield KA, Lipschutz RD, Lock BA, Kuiken TA. Improved myoelectric prosthesis control using targeted reinnervation surgery: a case series. IEEE Trans Neural Syst Rehabil Eng. 2008 Feb;16(1):46-50. doi: 10.1109/TNSRE.2007.911817.

ReferenceCitation: Gouzien A, de Vignemont F, Touillet A, Martinet N, De Graaf J, Jarrasse N, Roby-Brami A. Reachability and the sense of embodiment in amputees using prostheses. Sci Rep. 2017 Jul 10;7(1):4999. doi: 10.1038/s41598-017-05094-6.

lead_sponsor: Otto Bock France SNC

sponsor_collaborators:
Otto Bock France SNC
Euraxi Pharma

location_facility: Institut Régional de Rééducation et de Réadaptation


title: Comparison of Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG Raised in Closed Incubators: Impact on Body Growth and Morbidity

acronym: ThermoKPreterm

summary:
Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality.

A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
University Hospital, Rouen
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier Arras
Centre Hospitalier de Montreuil

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial

acronym: CINNAMON

summary:
Wounds can smell bad when they are necrotic, infected, malignant or complicated by fistulas or abscesses. The discomfort and evocations (perception) associated with these smells can be different from person to person. Foul odors are often associated with a repulsive effect. Malodorous wounds can have negative social and psychological repercussions (shame, depreciation, isolation).

Malodor is due to the presence of bacteria, whether the wound is colonized or infected. Bacteria release Volatile Organic Compounds (VOCs) that emit these odors. There are a multitude of anti-odor treatments (conventional or not) that highlight the difficulty of effectively treating this symptom.

Charcoal dressings are recommended. Charcoal does not treat the etiology, it is not odorous, but it has the ability to adsorb VOCs.

To treat odor, the most prescribed antibiotic is Metronidazole, because its action targets anaerobic bacteria whose presence increases odor. But repeated prescriptions of antibiotics increase the risk of selection pressure, in addition to possible side effects. It's not efficient in all the situations

Another strategy is the application of local antimicrobials. But it is effective only if the bacteria responsible for the odors are on the surface of the wound, which is not the case if it is a tumor mass, thick necrosis or abscesses.

These local or general treatments do not completely control bad odors in all situations. A new dressing combining adsorption capabilities (reduction of bad odors) with odor release (modification of the perception of residual odors) with cinnamon (CINESTEAM®) is now available.

This work aims to evaluate this new medical device compared to the reference dressing (charcoal) on quality of life, as well as criteria still poorly documented such as discomfort and appetite.

The primary endpoint is the percentage of patients with a reduction of at least 0.4 points in the overall score on the Wound-Qol questionnaire (Quality of life). It is estimated that a 0.4 point reduction in the overall score is a clinically relevant reduction for patients and reflects an improvement in their quality of life. An improvement of 0.4 points is expected in 25% of patients in the control arm (charcoal dressing) and in 55% of patients in the experimental arm (cinnamon dressing).

The study provides for the inclusion of 98 people with malodorous wounds in 3 hospital located on Ile de France.

Day 0: General data on the wound and current treatments will collected, Wound-Qol scale, lifestyle, discomfort related to smell, evaluation of appetite. The evaluated dressings will positioned on the top of primary dressing. They will fix by a non-occlusive or semi-occlusive fixation. The entire dressing will changed 1 time a day for 14 days.

Day 1: The patient will assess the discomfort related to the smell before changing the dressing.

Day 3: Assessment of the employability of the dressing by the caregiver.

Day 7 and 14: Assessment of the discomfort related to the smell by the patient, the caregiver and the entourage. Appetite will assessed with the SEFI® scale. Day 14 only: Wound-Qol scale and self-questionnaire on the appearance of any discomfort(s)/reaction(s) due to the dressing.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Treatment

ipd_sharing_description: Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

intervention_type: Other


title: Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students

acronym: POSITIVE

summary:
Scientific context: Students' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."

The studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.

Research hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student's issues in order to propose an appropriate intervention to improve their global health.

The study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.

status: Withdrawn

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral

status_simplified: Unknown


type: Other Identifier

title: Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study

acronym: SERASYMPTO

summary:
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).

Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.

The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection

study_completion_date_type: Actual

primary_purpose: Screening

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Pasteur


title: Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Score for Measuring Bowel Dysfunction After Sphincter-preserving Surgery Among Rectal Cancer Patients

acronym: LARS

summary:
Oncological rectal cancer outcomes have improved considerably because of optimal surgery by total mesorectal excision in conjunction with multidisciplinary team management by selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). The 5-year survival has increased to more than 50% and local recurrence has been reduced to less than 10%. These advancements have resulted in more patient receiving sphincter-preserving surgery (SPS). With an increasing number of rectal cancer survivors, the investigators observe a rising attention to the disordered bowel function after SPS, called "low anterior resection syndrome" (LARS). LARS appear immediately after surgery, becoming most pronounced during the first few months, and improved thereafter, reaching a steady state after around two years. However, up to 60% of patients with SPS suffer from LARS which impaired their quality of life (QoL). The prevalence and severity of LARS is difficult to assess due to heterogeneity of the assessment tools. A group of Danish authors have recently developed and validated a five-item instruments for evaluation of LARS (LARS score). It represents to date the best questionnaire to capture anorectal postoperative function and consists of five items: incontinence for flatus, incontinence for liquid stool, frequency of bowel movements, clustering of stools, and urgency. It allows a categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). Developed in Danish, it is now internationally validated with translations in Chinese, English, German, Spanish and Swedish. To our knowledge, French version of the LARS score is not yet available. The aim of our study will be to adapt the LARS scale questionnaire to the French language (LARS-F), and assess its psychometric properties.

Inclusion criteria will be patients 18 years old or above who were operated for rectal cancer from 2007 to 2015. Exclusion criteria will include the presence of stoma and/or known disseminated or recurrent disease. Patients will be identified through local databases by the local investigators at each of the participating centers with a minimum duration of 24 months after surgery to allow their bowel function to have regained stability. This study will be supported by the French Research Group of Rectal Cancer Surgery in order to allow the feasibility of the project.

After translation/back-translation procedures in accordance with the permission from the original authors, the LARS-F score and the whole translation process will be then sent to the original authors for approval. Then a pilot study will be conducted. The French questionnaire (LARS-F score) will be then administered to 100 patients in order to verify the adequacy and degree of comprehension of the questions. Reproducibility will be investigated by a test-retest procedure. A randomly selected subgroup of participants (n= 400) will be sent the LARS-F score questionnaire twice (with an interval of two weeks). The test-retest reliability of the questionnaire will be assessed by the Cohen's Kappa (no, minor and major LARS scores) or by intra-class correlation coefficient, ICC (quantitative LARS score). Then, eligible patients will receive a postal invitation to complete the LARS-F score and the l'European Organization for Research and treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. The validity of the LARS-F score will be tested by using the indicators of convergent validity and discriminant validity. The convergent validity will be determined notably in this study by computing the correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains. For discriminant validity testing, the investigators will use known variables to affect bowel function after SPS, such as gender, age, neo-adjuvant radiation therapy, distance of the tumor from the anal verge, prior temporary stoma, and length of postoperative period.

The validation of the French version of the LARS score will allow to use a scientific instrument in order to assess both prevalence and severity of LARS. This instrument will allow to develop a future research and clinical practice in France. It will be used in the daily clinical practice to identify patients with LARS score. It will hopefully lead to improve the awareness of clinicians, in order to improve the prevention and the treatment of bowel dysfunction, as well as the information given to patients. In the future, the investigators will able to develop a new patient-led follow-up program based on symptom burden and health-related QoL.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Sarcher T, Dupont B, Alves A, Menahem B. Anterior resection syndrome: What should we tell practitioners and patients in 2018? J Visc Surg. 2018 Oct;155(5):383-391. doi: 10.1016/j.jviscsurg.2018.03.006. Epub 2018 Aug 17.

ReferenceCitation: Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Rullier E, Rouanet P, Tuech JJ, Valverde A, Lelong B, Rivoire M, Faucheron JL, Jafari M, Portier G, Meunier B, Sileznieff I, Prudhomme M, Marchal F, Pocard M, Pezet D, Rullier A, Vendrely V, Denost Q, Asselineau J, Doussau A. Organ preservation for rectal cancer (GRECCAR 2): a prospective, randomised, open-label, multicentre, phase 3 trial. Lancet. 2017 Jul 29;390(10093):469-479. doi: 10.1016/S0140-6736(17)31056-5. Epub 2017 Jun 7.

ReferenceCitation: Lakkis Z, Manceau G, Bridoux V, Brouquet A, Kirzin S, Maggiori L, de Chaisemartin C, Lefevre JH, Panis Y; French Research Group of Rectal Cancer Surgery (GRECCAR) and the French National Society of Coloproctology (SNFCP). Management of rectal cancer: the 2016 French guidelines. Colorectal Dis. 2017 Feb;19(2):115-122. doi: 10.1111/codi.13550.

ReferenceCitation: Pieniowski EHA, Palmer GJ, Juul T, Lagergren P, Johar A, Emmertsen KJ, Nordenvall C, Abraham-Nordling M. Low Anterior Resection Syndrome and Quality of Life After Sphincter-Sparing Rectal Cancer Surgery: A Long-term Longitudinal Follow-up. Dis Colon Rectum. 2019 Jan;62(1):14-20. doi: 10.1097/DCR.0000000000001228.

ReferenceCitation: Battersby NJ, Bouliotis G, Emmertsen KJ, Juul T, Glynne-Jones R, Branagan G, Christensen P, Laurberg S, Moran BJ; UK and Danish LARS Study Groups. Development and external validation of a nomogram and online tool to predict bowel dysfunction following restorative rectal cancer resection: the POLARS score. Gut. 2018 Apr;67(4):688-696. doi: 10.1136/gutjnl-2016-312695. Epub 2017 Jan 23.

ReferenceCitation: Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.

ReferenceCitation: Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.

ReferenceCitation: Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

ReferenceCitation: Juul T, Elfeki H, Christensen P, Laurberg S, Emmertsen KJ, Bager P. Normative Data for the Low Anterior Resection Syndrome Score (LARS Score). Ann Surg. 2019 Jun;269(6):1124-1128. doi: 10.1097/SLA.0000000000002750.

ReferenceType: derived

ReferenceCitation: Eid Y, Bouvier V, Dejardin O, Menahem B, Chaillot F, Chene Y, Dutheil JJ, Juul T, Morello R, Alves A. 'French LARS score': validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol. BMJ Open. 2020 Mar 8;10(3):e034251. doi: 10.1136/bmjopen-2019-034251.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Caen

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

location_facility:
Chru Nantes
clc VANDEUVRE LES NANCY
Chru Tours
Caen University Hospital
Centre Oscar Lambret
Chru Amiens
Chru Lille
Chru Nancy

intervention_type: Diagnostic Test


title: Transrectal Prostate Cancer High-Intensity Focused Ultrasound Ablation: Assessment of Tissue Destruction With Shear-wave Ultrasound Elastography

summary:
Transrectal High-intensity Focused Ultrasound (HIFU) is a minimally-invasive therapy for prostate cancer that is currently assessed in two indications: as a first-line treatment (either total or focal) for patients who are not eligible for surgery and as a salvage treatment of local recurrences after radiotherapy.

It has recently been shown that Contrast-Enhanced Ultrasound (CEUS) can accurately assess the position and volume of tissue destruction at the end of prostate HIFU ablation. This can provide live feedback regarding the amount of residual non ablated tissue after HIFU treatment, which could allow immediate re-treatment in case of unsatisfactory result.

CEUS requires the injection of micro-bubbles of sulphur hexafluoride (Sonovue, Bracco, Milan, Italy) which can, at least in theory, interfere with HIFU treatment. Therefore, it is necessary to wait 20 to 30 minutes before re-treating the patient.

Shear-wave ultrasound elastography (SWUE, Supersonic Imagine, Aix-en-Provence, France) can quantify tissue stiffness. Moreover, post-HIFU necrosis is known to be stiffer than undestroyed prostate tissue. Therefore, SWUE could be an alternative to CEUS, and the purpose of this study is to evaluate the accuracy of SWUE in depicting the position and volume of therapeutic necrosis after prostate cancer High-Intensity Focused Ultrasound (HIFU) ablation.

The present study is an exploratory, monocentric, prospective, descriptive study. Three groups of 10 patients with prostate cancer will be evaluated: patients referred for first-line prostate HIFU ablation, patients referred for first-line HIFU hemi-ablation (focal treatment) and patients referred for salvage HIFU after radiotherapy.

SWUE will be obtained the day before HIFU ablation (D-1), immediately after HIFU ablation (D0) and the following day (D+1). CEUS will be performed immediately after HIFU ablation and D0 SWUE.

The primary endpoint is the comparison of the thickness of undestroyed parenchyma measured by SWUE and CEUS.

The secondary endpoints are:

The evolution of shear elasticity within the treated area measured by SWUE at D-1, D0 and D+1,
Adverse events related to SWUE.

The study will last 40 months.

status: Completed

design_allocation: Non-Randomized

primary_purpose: Diagnostic

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot

status_simplified: Completed


title: Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients

summary:
In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.

Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.

This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.

status: Unknown status

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon

intervention_type: Biological


title: Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study

acronym: ALCOSTIM

summary:
The fight against alcoholism is a public health priority. Around 15 million Europeans and 10 million North Americans are alcohol dependent. Worldwide, 1 death out of 25 is thought to be attributed to alcohol. In France, the latest published data on alcohol-related mortality indicates that there were 49,000 alcohol-related deaths in 2009. Alcohol is thought to be the leading cause of hospitalisation for French people, and its social cost is estimated at 37.4 billion euros.

However, few patients with an alcohol use disorder are treated: less than 8% in Europe and less than 10.5% in the USA receive appropriate treatment for their alcohol problem. This low rate of treatment is mainly due to the fact that these patients are not ready to stop drinking. They are therefore not attracted by the goal of abstinence that is required by most current therapies and drug treatments. The arrival of new treatments aimed at reducing consumption (rather than abstinence) should make treatment more attractive. To date, nalmefen is the only treatment marketed for this indication. Baclofen should be marketed in 2020, but with restrictive prescription criteria.

In this new strategy to reduce consumption, brain stimulation could play a predominant role as an alternative or complementary therapy. Indeed, functional brain imaging techniques have made it possible to visualise the cortical regions involved in craving, in particular the dorsolateral prefrontal cortex (DLPFC). Craving, i.e. the irrepressible desire to consume, is often at the origin of consumption and relapse. Stimulation of the dorsolateral prefrontal cortex with non-invasive cerebral stimulation techniques, such as repeated transcranial magnetic stimulation (rTMS), has provided encouraging results for the reduction of cravings in all addictive behaviours (alcohol, tobacco, cocaine, food). Furthermore, stimulation of the DLPFC seems to modulate decision-making processes: it may thus reduce impulsivity and strengthen inhibitory control, leading to a reduction in substance use.

The hypothesis to be tested is that repeated transcranial magnetic stimulation allows a reduction in alcohol consumption in patients with an alcohol use disorder.

ReferenceCitation: Petit B, Soudry-Faure A, Jeanjean L, Foucher J, Lalanne L, Carpentier M, Jonval L, Allard C, Ravier M, Mohamed AB, Meille V, Trojak B. Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial. Trials. 2022 Jan 12;23(1):33. doi: 10.1186/s13063-021-05940-z.

license: cc-by

license_normalized: cc-by

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Device

appel_a_projets: PHRCN

region: Bourgogne-Franche-Comté

nom_etablissement: CHU DIJON BOURGOGNE

type_etablissement: CH

acronyme: ALCSTIM tDCS

titre: Une étude randomisée menée en double aveugle évaluant l'efficacité de la Stimulation Transcrânienne à Courant Continu (tDCS) pour réduire la consommation d'alcool chez des patients non-abstinents souffrant d'un trouble de l'usage d'alcool

discipline_principale: psychiatrie / addictologie

nom_porteur: TROJAK

prenom_porteur: Benoît

appel_a_projets: PHRCI

acronyme: ALCOSTIM-TMS

titre: Efficacité de la rTMS haute fréquence dans la diminution de la consommation d'alcool chez des patients souffrant d'un trouble de l'utilisation de l'alcool : étude multicentrique randomisée, contrôlée.

discipline_principale: autre


title: Associated Psychiatric Disorders in Children Hospitalized for a Serious Suicide Attempt

acronym: SuiciDev

summary:
Several studies agree on the increase in suicide attempts in children over the past 15 years. This trend has been aggravated by the COVID 19 pandemic.

It is recognized that suicide attempts are mostly encountered in individuals with a psychiatric disorder. Serious suicide attempts, which probably better reflect the risk of completed suicide, are very poorly known and have been very little explored. They could be related to more specific and earlier psychiatric disorders or even concern children with developmental particularities that are insufficiently defined to fall under a categorical diagnosis, but which could be better understood with dimensional measurements. Better characterizing them would seem quite important given their high lethality. Indeed, a high lethality is found for half of the suicide attempts in children fewer than 12, contrasting with a moderate or low intentionality ; in children, the means used are often more violent and more lethal than in adolescents (over 12 years old): hanging, firearm, etc.

The Necker-Enfants Malades hospital has a pediatric neurosurgery department as well as a specialized multidisciplinary team to care for polytraumatized children in a regional "Trauma Center" type structure. As a result, most children and adolescents in Ile-de-France who have made a violent suicide attempt are sent to the Necker hospital. Once medico-surgically stabilized, these children and adolescents are assessed by the hospital's child psychiatry team. This regional recruitment makes it possible to have an epidemiological representativeness. From this population, the investigative team proposes to better characterize the developmental profile and psychiatric disorders of children who have made a serious suicide attempt.

The study also proposes to examine in detail the psycho-emotional development as well as the psychopathological characteristics of these children in order to shed light on these early and lethal acting out. The investigative team proposes in particular to use dimensional evaluations to analyze behavioral traits in more detail. To the knowledge of the child psychiatry department of the Necker Enfants Malades hospital, there is no such study to date.


title: Association Between Cancer and Anti-synthetase Syndrome : a Multicenter Study

summary: Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.

time_perspective: Retrospective

lead_sponsor: Central Hospital, Nancy, France

collaborators: Centre Hospitalier Universitaire de Besancon


title: Relevance of a Virtual Rehabilitation Program in Peripheral Facial Paralysis

acronym: RVPF

summary:
Facial palsy can be divided into supranuclear lesion (central facial palsy) and infranuclear lesion such as Bell's Palsy, an idiopathic disease. The peripheral facial paralysis (PFP) is a frequent but little-known pathology (20 / 100 000 inhabitants in France a year). Oro-facial functions and the ability to convey emotional facial information are seriously affected by facial palsy, thereby reducing patient's quality of life. The PFP can have several repercussions on the functional, aesthetic, social, occupational and psychological levels. Evolution and prognosis depend not only on its etiology and gravity, but also on the precocity and the quality of the medical and paramedical care. It is essential to assess functional and psychological issues before beginning an adapted global therapeutic care. If these depressive symptoms can be explained by multiple factors, the inability to smile would be one of the triggering factors of depression. The facial feedback hypothesis could be one of many explications because smiling induces a positive emotional state and a feeling of well-being. In PFP, patients must cope with their difficulties to smile. Their facial behaviour affected their own emotional experiences.

The main purpose of the present study is to determine if virtual rehabilitation program is relevant compared to standard therapy. The second aim is to characterize the efficiency by analysing the time required to obtain a stable score of 4 in the Sunnybrook test. A secondary objective will be to decrease the functional and social repercussions of the facial paralysis with an intensive and targeted therapy of the smile. Furthermore, a virtual rehabilitation program will be implemented in an interactive platform.

To this end, a parallel randomized controlled trial (RCT) of the two groups will be conducted: standard therapy versus virtual rehabilitation program. RCT involves a treatment in which active participation of the patient is necessary so only the assessment will be blinded. Facial motor skills (tongue, mouth and face motricity) are measured using electronic devices, objective and subjective evaluation with pragmatic fields such as communication, emotion and quality of life. The severity of patient's facial paralysis is appraised by the House and Brackmann scale. This global assessment will be conducted before the beginning of the therapy and every 3 months during 18 months.

The patients will be recruited within the Ear, Nose, and Throat (ENT) service after a baseline assessment. Simple randomization will be used in order to establish both therapeutic groups with 45 patients in each group.

Group A: Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation.

Group B: Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions.

The patients must have been diagnosed with unilateral peripheral facial palsy, according to House and Brackmann international classification.

Inclusion time : 18 months

Between-two-groups analysis will be conducted in order to compare a targeted and intensive implementation-intention rehabilitation such as virtual rehabilitation program to standard therapy. This virtual therapy will consist in repeating mentally movement desired, so that it will be more spontaneously executed in the every-day-life situation.

status: Terminated

ReferenceCitation: Diels HJ, Combs D. Neuromuscular retraining for facial paralysis. Otolaryngol Clin North Am. 1997 Oct;30(5):727-43.

appel_a_projets: PHRIP

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: RVPF

titre: Intérêt d'une réhabilitation virtuelle dans le cadre de la récupération des paralysies faciales périphériques

discipline_principale: orl

nom_porteur: GATIGNOL

prenom_porteur: Peggy


title: Metabolomics Based Prediction Model for Liver Graft Viability During Normothermic Regional Perfusion in Donation After Circulatory Death

summary:
With the increasing shortage of available donor organs, liver transplantation from donation after circulatory death (DCD) has been established in many countries to offer a therapeutic strategy for patients with end-stage liver disease beyond standard donation after brain death (DBD). In France, a controlled DCD (cDCD) program based on the use of normothermic regional perfusion (NRP) during organ procurement has been successfully implemented since 2015. This program has since shown excellent post-transplant outcomes with one-year patient and graft survival rates >90%. However, owing to very strict donor and graft selection criteria nearly one third of all potential liver grafts were not transplanted because of presumed poor quality. Furthermore, survival in cDCD liver transplantation which did not adhere to the current selection criteria was significantly lower (68% vs 94%) compared to the highly selected population. Thus, to further expand selection criteria and reduce discard rates without compromising outcomes, there is an urgent need for novel objective methods to assess graft quality prior to transplantation.

Graft quality assessment prior to transplantation has been a key challenge in liver transplantation for decades and still today the decision to accept or decline a graft before transplantation relies for the most part on ''gut feeling" of the procurement or transplant team. Currently, selection criteria for cDCD in France are based on donor data, liver biopsy results and hepatocyte injury markers AST and ALT. While donor data are only indirect indicators of graft quality, liver graft biopsy are highly pathologist dependant and do not provide a dynamic assessment. Hepatocyte injury markers during normothermic perfusion have been shown to only have limited value in predicting post-transplant graft function. In addition, several recent studies have suggested a superior predictive value of specific biomarkers in the liver through metabolomics. There is growing evidence that dynamic graft preservation such as NRP may even allow a direct analysis of key injury metabolites within solid organ grafts.

During cDCD procurement, liver grafts are exposed to donor warm ischemia which in combination with static cold storage causes ischemia-reperfusion injury (IRI) of the graft during implantation in the recipient. IRI is directly correlated to detrimental post-transplant complications such as primary non function and ischemic cholangiopathy or even recipient death.

Studies in animal models have revealed that mitochondria play a major role in IR injury and several mitochondrial signature metabolites for example succinate have been identified in various solid organ grafts such as livers, hearts and kidneys. Based on these results, our team and others have recently identified the release of a small auto fluorescent molecular compound of the mitochondrial respiratory chain, Flavin Mononucleotide (FMN), during the early phase of hepatic I/R injury. Furthermore, FMN has been shown to serve as a surrogate marker for impaired cellular energy production of the liver graft prior to transplantation and enable accurate prediction of post-transplant liver graft viability. Given the natural fluorescence of FMN, a real time quantification method has been established allowing to rapidly assess viability of human liver grafts during the procurement process. Of note, a team from the United Kingdom has validated this real-time FMN quantification during NRP of cDCD liver grafts. Interestingly, since mitochondrial injury is a universal signature of graft injury during the transplant process, FMN has the potential to serve as viability marker in other solid organs such as hearts, lungs and kidneys.

In addition, metabolomics approach allow the identification and quantification of many metabolites in a biological system through the use of high-throughput analytical technologies. It can give valuable information about what has, is and will occured in a specific tissu. In Liver transplantation, efforts have focused on studying early event of IR which are known to influence long term outcomes. It is however a complex pathway involving numerous metabolites. Metabolomic is therefore gaining interst in field of LT because it can enlight underlying metabolic process occurring during organ preservation and can lead the way toward a better evaluation of graft quality.

Thus, this study aims at developing a robust bio-clinical prediction model of liver graft viability during NRP using in depth metabolomics of perfusate and tissue in combination with available donor and graft characteristics

location_facility: Department of HPB surgery and liver transplantation

location_facility: Department of general surgery and liver transplantation, Croix-Rousse University Hospital 103 Boulevard de la Croix Rousse


title: OFSEP High Definition Cohort

acronym: OFSEP HD

summary:
For neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (MS), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course.

The overarching objective of the OFSEP-HD cohort is to determine prognostic factors of the evolution of disability in MS in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since MS clinical onset and along specific post-onset landmarks. This general framework leads to study 3 specific research objectives:

To identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (QoL), changes in classification, and biomarkers) for the progression of MS disease and its consequences;
To study the effectiveness of treatments in real life;
To merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management.

To achieve these objectives, the OFSEP (The French multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in France to create a large cohort of MS cases, providing high-definition and sequential multimodal data.

status: Active, not recruiting

ipd_sharing: Yes

lead_sponsor: EDMUS Foundation

location_country: Martinique France

location_facility:
CHU de Poitiers
CHU de Fort-de-France
CHU de Rennes
Fondation Rothschild
CHU d'Amiens
CHU de Nancy
CHU de Lyon
CHU de Lille
CHU de Dijon
CHU de Toulouse
CHU de Strasbourg
CHU Pitié-Salpétrière
CHU de Besançon
CHU de Créteil
CHU de Nantes
CHU de Nice
CHI de Poissy-Saint-Germain-en-Laye
CHU de Nîmes
CHU de Tours
CHU de Montpellier
CHU de Grenoble
CHU de Marseille
CHU de Bordeaux
CHU de Caen
CHU de Clermont-Ferrand
CHU de Limoges
CHU Saint-Antoine

lead_sponsor_type: industriel


title: Randomized Cross-over Pilot Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis

acronym: SFASPA

summary:
Spondyloarthritis is a potentially serious disease with reduced life expectancy. Even if the clinical presentation is eminently variable from one patient to another, the most frequently encountered manifestations such as inflammatory spinal pain, peripheral arthritis or even extra-articular involvement of the disease all represent disabling symptoms, origin of pain, temporary or in some cases permanent functional incapacity, but also general repercussions on daily life (asthenia, reactive depressive syndrome, etc.) which require a multidisciplinary approach, involving several medical, paramedical and other stakeholders, The objective of treatment is to improve quality of life, to control symptoms and inflammation, to prevent structural damage, particularly in peripheral damage, to preserve or restore functional capacities, autonomy and social participation of patients with spondyloarthritis.

In France, the main professional reference for shiatsu is the Syndicat des Professionnels de Shiatsu, which proposes the following definition to define shiatsu:

Shiatsu (finger pressure in Japanese) is an energetic manual discipline addressing the individual as a whole. Shiatsu is part of personal assistance. He receives himself, dressed in soft clothes. Shiatsu is a discipline of well-being and prevention for better health. Its objective is to correct both the energy flow (ki, blood, lymph, etc.) and the body structure (muscles, tendons, etc.) by applying rhythmic pressure to the whole body, most often with the inches. It is for everyone and at all ages. Its principle of action is to restore the free flow of Ki (qi, Energy) in the body.

Shiatsu is a set of pressures performed mainly with the thumbs and the palms of the hands on different areas of the body, often taking up the points of the acupuncture meridians. Shiatsu pressures can be (Ishizuka 1993; Kagotani 1984; Okamoto 2016):

mobile in a given place and lasting 3 to 5 seconds: a phase of increasing pressure followed by a short holding time then release,
static: same phases but with a hold time of up to approximately 1 minute or even longer.

To date, there is no treatment specifically targeting fatigue in axSpA. Indeed, the underlying mechanisms of fatigue in SpA remain poorly understood, and could for example involve pro-inflammatory cytokines and the inflammatory process, and/or psychological distress. The effectiveness of non-pharmacological interventions and in particular the care provided by shiatsu practitioners have not been the subject of studies evaluating, according to the criteria of evidence-based medicine, the benefit of this practice, particularly in the context of treatment of spondyloarthritis.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Prognosis of Klebsiella ESBL Sepsis: Role of 2-HYDRoxy-myristate in Endotoxin Structure

summary:
Infections constitute a multiple and heterogeneous set of pathologies, and the first cause of mortality worldwide. Among them, sepsis is a more recent nosological entity, including the most severe forms of acute infectious pathologies, its frequency increasing considerably over time. It is considered to be the cause of more than 27 million deaths per year, more than 4,000 deaths per day in the United States and about 200 deaths per day in intensive care units in France.

The occurrence of hemodynamic failure within visceral damage is a poor prognostic factor, the lethality in this situation can reach 60% of affected patients. The amount of organ dysfunction is also prognostic. More worryingly, the initial mortality is aggravated by the persistence of the negative evolution after hospital treatment, the 5-year prognosis being significantly more severe in the population of patients treated for sepsis than in the general population, particularly in the case of respiratory or cardiovascular damage during the stay in intensive care. The most frequent causes of these severe infections in the ICU are lower respiratory infections, particularly pneumonia acquired under mechanical ventilation, urinary tract infections and digestive tract infections.

Sepsis corresponds to an infection of particular severity, which results in the association of organ failures, the type and severity of which vary according to the patient, the origin of the infection and the pathogen responsible. The severity of the picture will require specific management and may necessitate the introduction of organ supplements or even lead to death in the most serious forms.

Infections by enterobacteria and in particular Klebsiella spp. are frequent in the intensive care unit. The association with antibiotic resistance and especially with ESBL production is a daily clinical situation. During these infections, the prognosis is variable, sometimes very poor, without it being possible to determine whether this evolution is due to antibiotic resistance or to the virulence of the pathogen. The objective of this work is to study the structure of lipid A of ESBL-producing Klebsiella strains responsible for nosocomial infections. This study is part of the "EVENT" protocols of which it is an ancillary analysis.

The objective of this study is to evaluate the role of the presence of 2-hydroxymyristate within lipid A of the lipopolysaccharide in the prognosis of ESBL-producing Klebsiella infections in the ICU. The secondary objectives correspond to the evaluation of the vital prognosis according to the infected organ (lung, kidney, digestive system), and the presence of 2-hydroxymyristate and the risk of bacteremia.

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: acceptedVersion

repository_institution: King's College London - Research Portal

repositories:
PubMed Central
UCL Discovery
kclpure.kcl.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687.

ReferenceCitation: Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2.

ReferenceCitation: de Grooth HJ, Postema J, Loer SA, Parienti JJ, Oudemans-van Straaten HM, Girbes AR. Unexplained mortality differences between septic shock trials: a systematic analysis of population characteristics and control-group mortality rates. Intensive Care Med. 2018 Mar;44(3):311-322. doi: 10.1007/s00134-018-5134-8. Epub 2018 Mar 15.

ReferenceCitation: Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.

ReferenceCitation: Shankar-Hari M, Harrison DA, Ferrando-Vivas P, Rubenfeld GD, Rowan K. Risk Factors at Index Hospitalization Associated With Longer-term Mortality in Adult Sepsis Survivors. JAMA Netw Open. 2019 May 3;2(5):e194900. doi: 10.1001/jamanetworkopen.2019.4900.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Prognostic Interest of a Whole Body Dynamic PET Acquisition in Pre-therapeutic 68Ga-DOTATOC PET/CT for Neuroendocrine Tumors

acronym: GAPET-NET

summary:
Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.

However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.

Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.

Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.

However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.

The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


type: Registry Identifier

title: Immune Responses to COVID-19 (SARS-CoV-2 Related Infection); Isolation of Human Neutralizing Monoclonal Antibodies for Therapeutics and Vaccine Design Approaches: a Prospective Monocentric Trial With Collaborative Sample Collection.

summary:
According to different projections, the COVID-19 outbreak currently happening in France and worldwide could result in millions of deaths in the absence of efficient therapies. The COVID-19 causative agent, the SARS-CoV-2, is a virus leading to respiratory system infections in human and for which there is currently no vaccine or treatment scientifically validated in clinical studies.

In that context, therapeutic human neutralizing antibodies targeting the SARS-CoV-2 envelop glycoproteins and which enable inhibition of the viral replication represent an innovative therapeutic alternative with great potential. These antibodies are also critical tools for vaccine development.

Simultaneously, CHUGA researchers coordinate with each other to set up a collective biological collection to achieve others objectives such as biomarkers identifications.

ReferenceCitation: Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

ReferenceCitation: Haveri A, Smura T, Kuivanen S, Osterlund P, Hepojoki J, Ikonen N, Pitkapaasi M, Blomqvist S, Ronkko E, Kantele A, Strandin T, Kallio-Kokko H, Mannonen L, Lappalainen M, Broas M, Jiang M, Siira L, Salminen M, Puumalainen T, Sane J, Melin M, Vapalahti O, Savolainen-Kopra C. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020. Euro Surveill. 2020 Mar;25(11):2000266. doi: 10.2807/1560-7917.ES.2020.25.11.2000266.

ReferenceCitation: Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19.

ReferenceCitation: Alshukairi AN, Khalid I, Ahmed WA, Dada AM, Bayumi DT, Malic LS, Althawadi S, Ignacio K, Alsalmi HS, Al-Abdely HM, Wali GY, Qushmaq IA, Alraddadi BM, Perlman S. Antibody Response and Disease Severity in Healthcare Worker MERS Survivors. Emerg Infect Dis. 2016 Jun;22(6):1113-5. doi: 10.3201/eid2206.160010.

ReferenceCitation: Liu W, Fontanet A, Zhang PH, Zhan L, Xin ZT, Baril L, Tang F, Lv H, Cao WC. Two-year prospective study of the humoral immune response of patients with severe acute respiratory syndrome. J Infect Dis. 2006 Mar 15;193(6):792-5. doi: 10.1086/500469. Epub 2006 Feb 9.

ReferenceCitation: Tetro JA. Is COVID-19 receiving ADE from other coronaviruses? Microbes Infect. 2020 Mar;22(2):72-73. doi: 10.1016/j.micinf.2020.02.006. Epub 2020 Feb 22.

ReferenceCitation: Walker LM, Phogat SK, Chan-Hui PY, Wagner D, Phung P, Goss JL, Wrin T, Simek MD, Fling S, Mitcham JL, Lehrman JK, Priddy FH, Olsen OA, Frey SM, Hammond PW; Protocol G Principal Investigators; Kaminsky S, Zamb T, Moyle M, Koff WC, Poignard P, Burton DR. Broad and potent neutralizing antibodies from an African donor reveal a new HIV-1 vaccine target. Science. 2009 Oct 9;326(5950):285-9. doi: 10.1126/science.1178746. Epub 2009 Sep 3.

ReferenceCitation: Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators; Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373.

ReferenceCitation: MacLeod DT, Choi NM, Briney B, Garces F, Ver LS, Landais E, Murrell B, Wrin T, Kilembe W, Liang CH, Ramos A, Bian CB, Wickramasinghe L, Kong L, Eren K, Wu CY, Wong CH; IAVI Protocol C Investigators & The IAVI African HIV Research Network; Kosakovsky Pond SL, Wilson IA, Burton DR, Poignard P. Early Antibody Lineage Diversification and Independent Limb Maturation Lead to Broad HIV-1 Neutralization Targeting the Env High-Mannose Patch. Immunity. 2016 May 17;44(5):1215-26. doi: 10.1016/j.immuni.2016.04.016.

ReferenceCitation: Landais E, Murrell B, Briney B, Murrell S, Rantalainen K, Berndsen ZT, Ramos A, Wickramasinghe L, Smith ML, Eren K, de Val N, Wu M, Cappelletti A, Umotoy J, Lie Y, Wrin T, Algate P, Chan-Hui PY, Karita E; IAVI Protocol C Investigators; IAVI African HIV Research Network; Ward AB, Wilson IA, Burton DR, Smith D, Pond SLK, Poignard P. HIV Envelope Glycoform Heterogeneity and Localized Diversity Govern the Initiation and Maturation of a V2 Apex Broadly Neutralizing Antibody Lineage. Immunity. 2017 Nov 21;47(5):990-1003.e9. doi: 10.1016/j.immuni.2017.11.002.

ReferenceCitation: Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19. No abstract available.

ReferenceCitation: Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.

ReferenceCitation: Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

ReferenceCitation: Lin L, Lu L, Cao W, Li T. Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia. Emerg Microbes Infect. 2020 Dec;9(1):727-732. doi: 10.1080/22221751.2020.1746199.

ReferenceCitation: Saylor C, Dadachova E, Casadevall A. Monoclonal antibody-based therapies for microbial diseases. Vaccine. 2009 Dec 30;27 Suppl 6:G38-46. doi: 10.1016/j.vaccine.2009.09.105.

ReferenceCitation: Casadevall A. Antibody-based vaccine strategies against intracellular pathogens. Curr Opin Immunol. 2018 Aug;53:74-80. doi: 10.1016/j.coi.2018.04.011. Epub 2018 Apr 25.

ReferenceCitation: Stadlbauer D, Amanat F, Chromikova V, Jiang K, Strohmeier S, Arunkumar GA, Tan J, Bhavsar D, Capuano C, Kirkpatrick E, Meade P, Brito RN, Teo C, McMahon M, Simon V, Krammer F. SARS-CoV-2 Seroconversion in Humans: A Detailed Protocol for a Serological Assay, Antigen Production, and Test Setup. Curr Protoc Microbiol. 2020 Jun;57(1):e100. doi: 10.1002/cpmc.100.

ipd_sharing: Undecided

ipd_sharing_description:
All investigators should have submitted their first publication before study board deciding to share individual participant data.

Furthermore, sharing individual participant data require a contract according to RGPD law.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique


title: Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers

acronym: EXPLANT

summary:
Of the 50,000 prostate cancers that occur each year in France, more than half will benefit from curative radiotherapy, alone or in combination with hormone therapy from 6 months to 3 years depending on the stage of the disease. At present, there are few ways to predict the response to this irradiation.

Evaluating the early response of tumor tissue to irradiation could predict the final response to treatment. It is difficult to offer biopsies during treatment for reasons of patient comfort. This is why this study consists in analysing transcriptomic and protein responses (immunohistochemistry) to irradiation on ex vivo prostate explants. These explants will be irradiated after culture and the transcriptional and immunohistochemical changes analysed before and after irradiation to determine an early tumor tissue response profile to irradiation.

primary_purpose: Other

lead_sponsor: Institut Cancerologie de l'Ouest


title: Evaluating a Therapeutic Association Between CMV-specific Immunoglobulin Infusion and Pre-transplant CD16-expressing Gamma Delta Vdelta 2 Negative T-cells in CMV-positive Patients for Preventive Treatment of CMV Infection in Renal Transplantation

acronym: SYNTAGME

summary:
CMV infection in transplantation remains the most frequent infectious complication causing increased morbidity and mortality. International recommendations advocate prevention of this infection by instituting direct antiviral treatment or monitoring viral replication by PCR with the start of curative antiviral treatment when the DNAemia is positive.

The risk of CMV infection varies according to the serostatus of the donor (D) and recipient (R) at the time of transplantation. In the absence of prophylaxis, CMV infection occurs in 60-80% of D+R-, 50-60% of D+R+ and 25-50% of D-R+.

The humoral anti-CMV response is represented by the production of antibodies to envelope proteins (gB and gH) and to molecules involved in viral attachment and entry into target cells. However, the majority of CMV-specific antibodies do not have antiviral neutralising activity. The investigators have identified a new player in the specific anti-CMV response expressing the Fc RIIIa receptor (CD16), that interacts with anti-CMV immunoglobulins (Ig): the Tgamma-delta V delta 2-negative lymphocyte (LTgdVd2neg). This lymphocyte subpopulation shows persistent expansion in the peripheral blood of kidney transplant patients with CMV infection. These cells express an effector-memory phenotype (CD45RA+/CD27-). This expansion is associated with resolution of infection in patients. The investigators have shown that CD16 is specifically and constitutively expressed on the surface of CMV-induced LTgdVd2neg in healthy volunteers and kidney transplant patients. The investigators have observed that one of the antiviral activities of anti-CMV IgG lies in its binding to the Fc RIIIa receptor (CD16) on the surface of LTgdVd2neg. The anti-CMV IgGs capturing virions thus activate CD16+ LTgdVd2neg with production of IFN interferon which in turn is responsible for inhibition of CMV viral multiplication.

Anti-CMV IgG is a recommended therapeutic option, with a marketing authorisation for the prevention of CMV infection in kidney transplantation in Europe and a Temporary Authorisation for Use in France.

Thus, R+ patients expressing a significant level of LTgdVd2neg CD16+ at D0 of transplantation could be protected against CMV, in the absence of direct antiviral treatment by the addition of anti-CMV Ig.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Biotest

intervention_type: Drug


title: Multicenter Randomized Controlled Trial Evaluating the Effectiveness and Cost-effectiveness of the Use of Short Message Service (SMS) in the Screening Invitation Strategy for Breast Cancer.

acronym: USIMaPI

summary:
Each year in France, breast cancer affects about 48,000 women and is the first cause of cancer death in women with 11,900 deaths estimated.

Since 2004, there is a national organized breast cancer screening (OBCS) programme for asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer screening department sends a personalized invitation mail to eligible women to perform a mammogram and a breast clinical examination. One to two reminder mails are sent to women who have not done the screening after an initial invitation. Despite this programme, almost 47% of women in France do not participate to organized breast cancer screening.

The Short Message Service (SMS) is an innovative communication tool in the field of health, immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative, low-cost, personalized and ecological way to support the OBCS invitation strategy.

The overall objective of this study is to preserve or even better increase participation in organized breast cancer screening while decreasing the associated costs by including SMS in our screening invitation procedure.

Two SMS interventions will be tested which will correspond to different phases of the OBCS invitation procedure. This sequence of interventions leads us to perform three interlinked trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days before the initial mail invitation), then two non-inferiority trials for the second phase ( two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the first postal reminder).

lead_sponsor: University Hospital, Tours


title: Hematopoietic Stem Cell Transplantation and Childhood Leukemia: Quality of Life in SIbling DONors, Years After the Donation

acronym: SIDONY

summary:
The childhood cancer experience necessarily impacts the entire family. In this context, particular attention should be paid to the donor siblings of hematopoietic stem cells in the context of treatment of leukemia by grafting.

The results of the little existing work on the long-term fate of stem cell donor siblings of cancer survivors report psychosocial consequences, particularly for real post-traumatic stress in distant siblings.

Few studies have explored the medium and long-term impact of the disease, as well as donation, on a broader set of domains structuring the quality of life, through validated quantitative tools.

In France, since 2004, the LEA program (Leukemia of the Child and Adolescent) aims to assess the determinants of the state of health and quality of life in the medium and long term, patients treated for acute childhood leukemia after 1980.

The main objective of this study is to evaluate, at a distance from the transplant, the quality of life of donors from the siblings of survivors of acute childhood leukemia who received a hematopoietic stem cell transplant compared with non-donor siblings.

The SIDONY ancillary study will be proposed to families of LEA patients who have received a geno-identical sibling haematopoietic stem cell transplant (population of interest) and to families whose LEA patient has not been treated by sibling transplantation. geno-identical but still declaring to have siblings (main comparator group). Each family will be contacted by mail and the management of inclusions will be managed by the Epidemiology and Health Economics Department of AP-HM (Marseille).

Information not routinely available in the LEA database will be collected from the siblings (self-questionnaire, in addition, for each surviving child included in the cohort, data are available: sociodemographic; characteristics of the initial disease and therapeutic received; physical sequelae; quality of life.

The population meeting the inclusion criteria represents 2639 subjects: 337 donors and 2302 non-donors, making it possible to obtain high powers for analyzes (linear regression, multilevel analyzes, etc.). This study could identify profiles of siblings for whom the quality of life seems particularly impaired, potential object of individual interventions (remediation ...).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: SIDONY

titre: Quel impact à distance de la greffe de cellules souches hématopoïétiques sur la qualité de vie des donneurs issus de la fratrie des survivants d'une leucémie aiguë de l'enfance ?

discipline_principale: cancer epidémiologie

nom_porteur: BERBIS

prenom_porteur: Julie


title: Effect of Imipenem and Meropenem on the Digestive Microbiota and the Emergence and Carriage of Multidrug-resistant Bacteria

acronym: MERIMI

summary:
Among enterobacteria, ESBL production is the leading cause of multidrug resistance. The first cases of ESBL-producing Enterobacteriaceae (EBLSE) infections were described in the 1980s and subsequently spread worldwide.

Since the turn of the century, the prevalence of EBLSE infections, particularly among E. coli and K. pneumoniae, has increased dramatically. The emergence of multidrug-resistant enteric bacteria (MRE) is currently a real public health problem. The European network for monitoring antibiotic resistance in cooperation with Santé Publique France evaluated the rate of resistance to third generation cephalosporins (C3G) among clinical strains at 10.2% for Escherichia coli and 28.8% for Klebsiella pneumoniae. The consequences of infections with multi-resistant enteric bacteria, mainly represented by ESBL, are currently well known, both from an individual point of view (increased mortality and length of hospitalization) and from a collective point of view (increased costs of care).

The current reference treatment for ESBL-producing Enterobacteriaceae infections is based on carbapenems.

Imipenem and meropenem are the two most commonly used carbapenems in clinical practice. Despite their similar spectrum of action, these two molecules have different pharmacokinetic properties, notably concerning their half-life and their elimination routes (mainly urinary for imipenem, mixed: biliary and urinary for meropenem).

Some studies have suggested that imipenem has a low impact on the digestive microbiota. However, no studies comparing the impact of imipenem and meropenem have been conducted.

Woerther et coll. explained in their work that the digestive microbiota confers resistance to colonization by MREs. The impact of antibiotics on the microbiota probably leads to a breakdown of this barrier and a loss of this resistance to colonization. Moreover, each antibiotic therapy does not impact the digestive microbiota in the same way and it seems that antibiotics with a high activity against strict anaerobic species and/or a high biliary elimination are the most impacting. It is therefore essential, in the era of multidrug resistance, to look at the influence of antibiotics on the digestive microbiota and on the emergence and carriage of MRE.

In a context where the incidence of multi-resistant bacteria is constantly increasing, it seems relevant to conduct a study aiming at comparing the respective impact of the use of imipenem and meropenem on the emergence of MRE and on the digestive microbiota at the individual level. This study aims at comparing the microbiological impact (in terms of emergence of bacterial resistance and in terms of impact on the diversity of cultivable digestive bacteria). It will be a comparative study with matching of patients according to age, service and previous duration of hospitalization. Indeed, the usual management of patients with an infection requiring treatment with a carbapenem is different between the 2 participating centers. Thus, according to the usual management of patients in these 2 participating centers, patients at Avicenne Hospital are treated with meropenem and patients at the Paris Saint-Joseph Hospital Group with imipenem, except in the case of a need for a high daily dose (osteoarticular infection, for example) due to the neurological toxicity of imipenem at high dosage. In the case of high-dose use, meropenem will be the preferred molecule.

ReferenceCitation: Schwaber MJ, Navon-Venezia S, Kaye KS, Ben-Ami R, Schwartz D, Carmeli Y. Clinical and economic impact of bacteremia with extended- spectrum-beta-lactamase-producing Enterobacteriaceae. Antimicrob Agents Chemother. 2006 Apr;50(4):1257-62. doi: 10.1128/AAC.50.4.1257-1262.2006.

ReferenceCitation: Gudiol C, Calatayud L, Garcia-Vidal C, Lora-Tamayo J, Cisnal M, Duarte R, Arnan M, Marin M, Carratala J, Gudiol F. Bacteraemia due to extended-spectrum beta-lactamase-producing Escherichia coli (ESBL-EC) in cancer patients: clinical features, risk factors, molecular epidemiology and outcome. J Antimicrob Chemother. 2010 Feb;65(2):333-41. doi: 10.1093/jac/dkp411. Epub 2009 Dec 3.

ReferenceCitation: Woerther PL, Lepeule R, Burdet C, Decousser JW, Ruppe E, Barbier F. Carbapenems and alternative beta-lactams for the treatment of infections due to extended-spectrum beta-lactamase-producing Enterobacteriaceae: What impact on intestinal colonisation resistance? Int J Antimicrob Agents. 2018 Dec;52(6):762-770. doi: 10.1016/j.ijantimicag.2018.08.026. Epub 2018 Aug 31.

ReferenceCitation: Ruppe E, Burdet C, Grall N, de Lastours V, Lescure FX, Andremont A, Armand-Lefevre L. Impact of antibiotics on the intestinal microbiota needs to be re-defined to optimize antibiotic usage. Clin Microbiol Infect. 2018 Jan;24(1):3-5. doi: 10.1016/j.cmi.2017.09.017. Epub 2017 Sep 29. No abstract available.

ReferenceCitation: Ruppe E, Lixandru B, Cojocaru R, Buke C, Paramythiotou E, Angebault C, Visseaux C, Djuikoue I, Erdem E, Burduniuc O, El Mniai A, Marcel C, Perrier M, Kesteman T, Clermont O, Denamur E, Armand-Lefevre L, Andremont A. Relative fecal abundance of extended-spectrum-beta-lactamase-producing Escherichia coli strains and their occurrence in urinary tract infections in women. Antimicrob Agents Chemother. 2013 Sep;57(9):4512-7. doi: 10.1128/AAC.00238-13. Epub 2013 Jul 8.

location_facility:
Hôpital Avicenne
Groupe Hospitalier Paris Saint-Joseph


title: Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial

acronym: PARTO-MAP

summary:
Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work.

Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity.

The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments.

The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients.

The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days.

However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care.

The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.


title: Preventive Fixation of Lower Limbs in Osteogenesis Imperfecta (Brittle Bone Disease) With the Highlight of the Fassier-Duval

acronym: Fassier-Duval

summary:
Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real congenital osteoporosis. The prevalence of the disease is not known precisely, but it is 1 in 10000 at 20000. There are many forms of osteogenesis imperfecta to classify patients with symptomatology minor to the patients with lethal form during the neonatal period. The main symptoms are dominated by fractures and bone deformities, particularly in the lower limbs. Bisphosphonate medication is used for over 10 years to reduce the number of fractures. However the long-term effects are not known to date, not allowing even to establish proof of the benefit risk. Thus unable to process all of these patients and over a long time, these drug treatment leaves much therapeutic solutions to surgery. The goal of surgery is to treat fractures, treat bone deformities and prevent fractures future. In the long bones of the limbs, the only effective techniques are intramedullary nailing. The majority of realized nailing nailing are either sliding or telescopic enabling having a reinforced bone of an intramedullary osteosynthesis material over its entire length during the period of bone growth. It has been shown that the technique of the sliding nailing was inexpensive but reliable especially before the age of 5 years. After that age, all are telescopic nailing nailing. The first telescopic nail described is the Bailey-Dubow nail still widely used in France. However, the number of complications relating to its use is important. Thus, there are 8% of disunity equipment and 33 to 72% of the nail migration forcing him to change one or more times during growth. A new nail presented at the French orthopedic company in 2005 and Fassier Duval reported a much lower complication rate because the rate of nail migration is only 9%, without opening the knee joint, which is not possible with the highlight of Bailey-Dubow.

It is proposed to conduct a prospective series of 10 nailing the lower extremities with this nail Fassier-Duval in patients with osteogenesis imperfecta and compare the results with a series of patients already treated with Bailey-Dubow nails in order to highlight the advantages and disadvantages of using of such a nail.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Quality of Life and Fertility of Patient With Deep Surgical Endometriosis: a Prospective Cohort

acronym: ENDORAA

summary:
Endometriosis is a common gynaecologic disease affecting 5 to 15% women of reproductive age and up to 40% of infertile women. It is characterized by the presence of active endometrial tissue outside the uterine cavity, potentially causing invalidating chronic pelvic pain and infertility. It is therefore crucial to limit the progression and/or recurrence of the disease, and to improve the quality of life of affected women.

Deep infiltrating endometriosis (DIE), an advanced form of the disease, is defined by the invasion of an anatomical structure and organ close to the uterus (i.e. uterosacral ligament, rectovaginal space, recto-sigmoidal colon or bladder), or by a peritoneal invasion greater than 5mm. The management of DIE is unfortunately not yet based on high-level evidence data; it mainly depends on the localization of the disease, the extend of the invasion and the severity of the symptoms. In the absence of clear guidelines based on empirical data, the choice between surgical or medical treatment remains difficult and controversial.

To improve optimal DIE management, the investigators aim to create a prospective database reporting on DIE surgically treated in a teaching hospital in Lyon/France (Centre hospitalier universitaire Lyon Sud)

Data on known risks factors, symptoms (pain), quality of life, infertility history and disease management will be obtained using self-questionnaires, clinic, paraclinic, surgical and histological records as follow.

Each patient will be asked to fill in electronics protected on-line forms: the first one before surgery, followed by three follow-up forms at 1, 2 and 5 years after surgery.
The surgeon will be asked to fill in two electronic protected on-line forms: the first one at the time of surgery and the second one during a post-operative consultation (one month after surgery).

The questionnaires used in this study are similar to those used for the Endometriosis database "CIRENDO" (explain briefly what it is), which will ultimately allow us to pool the data from the 2 databases.

This French prospective study will advance the scientific knowledge on DIE surgical treatment and, by helping evaluate the impact of the surgery on the quality of life and fertility of affected women, will guide future recommendations for an optimal management of this invalidating disease.


title: DELI-DEVI : Determinants of End-of-life Place of Care for Children Suffering From Cancer.

acronym: DELI-DEVI

summary:
Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life.

Pediatric guidelines about the place of end-of-life care are varied. On European scale, home is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development program recommended home or initial hospital care unit. This program also supports implementation of mobile team rather than specific hospital units.

In Brittany, a pattern of regional palliative care resource team has been implemented since 2005. In oncology, further to the guidelines, end-of-life place of care is often discussed several times for each case. Sometimes occur a lot of returns between home and hospital, psychological difficulties, and difficulties to offer adapted care conditions. Finally, less than 30% of children in palliative care decease at home.

The primary objective is to identify main determinants of the place of palliative care in pediatric oncology.

The secondary objective is to clarify the factors of change comparing to the initial planned place.

Intervention :

Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative phase, that means 136 to 186 parents.

Expected results and perspectives :

Using both quantitative and qualitative methods, expected results are the followings:

Identification of the objective and subjective factors, which influenced the decision of the place of care.
Determination of the factors of change comparing to the initial planned place.

Once identified, main factors could be the ones to pay attention to in order to help for initial decision, better anticipation of change of place and better guidance of palliative care organization wherever, at home or in hospital.

Results would be new information for research on palliative care for children but also for adults.

Finally, this work is part of an improving approach of palliative care, related to the development of open-care hospital networks. We can expect some public health impacts with new arguments to help for complementary recommendations.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
University of Rennes 2


title: Biomarkers in Acute Abdomen (BIOMAB)

acronym: BIOMAB

summary:
Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.

Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.

Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.

Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.

Study population: 200 patients presenting to the ED with acute abdomen

Eligibility criteria:

Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years
Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance

Procedure:

Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.

Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.

Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.

Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.

Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.

lead_sponsor: Pitié-Salpêtrière Hospital

collaborators: Association pour la Recherche et la Formation en Anesthésie Analgésie Réanimation

location_facility: Service d'Accueil des Urgences, CHU Pitié-Salpêtrière


title: Study of the Value of Trio Exome Sequencing in the Etiological Assessment of Specific Non-syndromic Language and Learning Disorders

acronym: TSLA ES

summary:
Specific language and learning disorders (SLLD) affect around 5-10% of school-aged children, or 1-2 child(ren) per class. SLLDs correspond to the impairment of a specific cognitive function and are divided into 5 categories: dyslexia, dysphasia, dyspraxia, dyscalculia and attention deficit hyperactivity disorder (ADHD) (DSM-5). In recent years, real progress has been made in their clinical diagnosis and management, thanks to a better description of these disorders in the DSM-5 and the advent of rehabilitative treatments (neuropsychology, speech therapy, occupational therapy, orthoptics, etc.). SLLD can occur in a sporadic or familial context (sibling involvement, a symptomatic parent, other relatives who may mimic dominant inheritance with variable expressivity and incomplete penetrance).

It has long been suspected that SLLD is secondary to multifactorial inheritance, with a combination of frequent genetic variations and environmental factors. In France, in the absence of an obvious syndromic diagnosis, the current strategy is to prescribe array CGH, combined in girls with a search for fragile X syndrome (in boys, this syndrome leads to systematic intellectual disability, which does not justify its study in SLLD). A few genes have been described as being specifically involved in a small proportion of SLLD, most often with de novo variations or inherited from a symptomatic parent. There are no distinctive clinical features to guide targeted sequencing of these genes. Moreover, our recent experience shows that genes implicated in intellectual disability may also be involved in SLLD. Very few studies have been published in the literature evaluating the value of exome sequencing in SLLD. Only two studies have been identified, involving 10 and 43 patients with specific SLLD.

In view of the roll-out of the French Genomic Medicine Plan (PFMG 2025), it is important to set up a study aimed at assessing the value of genome-wide sequencing in the etiological work-up for SLLD.

Participation in the study consists of:

an inclusion visit, where an additional blood sample will be taken during the baseline work-up
a results visit (4 months after the inclusion visit)

Optional qualitative study: semi-structured interview 1 year after the inclusion visit proposed to 20 patients or families with a positive result and to 10 patients with a negative result.


title: "Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis"

acronym: NINTECOR

summary: Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Boehringer Ingelheim


title: Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients - NEO Study

summary:
Non-Alcoholic Fatty Liver is a common clinical and histological condition associated with metabolic syndrome in patients with and without excess body weight. It represents the most common cause of liver disease in the western world and it is characterized by an excess accumulation of fatty vacuole within hepatocytes.

Patients with non-alcoholic fatty liver disease (NAFLD) can progress to non-alcoholic steatohepatitis (NASH), and then into cirrhosis and its complications.

The prevalence of hepatic steatosis goes from 16 to 31% in the general population, from 50 to 80% in the obese population and up to 96% in morbidly obese patients. As the majority of obese individuals have NAFLD, non-invasive and widely applicable screening tools for the assessment of liver fibrosis and steatosis are needed. The detection in early stages is the main predictive factor of the long-term outcome.

Liver biopsy has traditionally been the gold standard for the assessment of patients with NAFLD, although the well-known limitations. Among the non-invasive tools available in the market, the FibroScan® (Echosens™, Paris, France) has been shown to be a useful tool for diagnosing fibrosis and steatosis in patients with suspected NAFLD. The FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM) and the controlled attenuation parameter (CAP).

Several clinical studies have shown the benefit of measuring hepatic stiffness with the FibroScan® in overweight/moderately obese persons. The ability to identify significant fibrosis and cirrhosis has been demonstrated in normal and overweight patients affected with chronic hepatitis B and C, biliary diseases, alcohol related liver disease and NAFLD.

However, subcutaneous fat attenuates the transmission of shear waves into the liver and the ultrasonic signals used to measure their speed of propagation. When scanning morbidly obese patients (BMI≥35 kg/m²) with the XL+ probe, unreliable results occur mainly due to obesity. Therefore, the XL probe has been enabled to expand the applicability of the FibroScan® but, the realization of the XL+ examination is still very difficult in the case of morbidly obese patients. This is why to reduce this failure rate, Echosens has worked on developing the XXL probe specifically for measuring the LSM in morbidly obese patients.

lead_sponsor: Echosens