title: Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery

acronym: Preo-Dens

summary:
Pulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and severity of postoperative complications in this population of patients. Despite these benefits, the most recent meta-analyzes highlight the fact that training modalities (duration, frequencies, intensity) are very heterogeneous. It is then difficult to structure a program only on the basis of data from the literature.

In a cohort analysis of 50 patients trained from 2014 to 2017, our team reported a significantly greater improvement in physiological parameters in patients who performed 15 or more preoperative training sessions. This number of 15 outpatient sessions is therefore considered a minimum training goal in our current practice.

The difficulty of the oncological context is to find the compromise between the necessary diligence to initiate the cancer surgical treatment and the necessary time to obtain the benefits of the preoperative rehabilitation. Previous study reports the difficulty of setting up a four-week training program, perceived as delaying surgery. In order to prevent any risk of prolonging the surgical management time, rehabilitation teams routinely offer short programs with high training frequencies of up to five to six sessions per week. It seems important to note that preoperative rehabilitation is normally considered in patients for whom there is a risk of moderate to high postoperative complications according to the European and North American recommendations. Thus these patients generally benefit from a longer period of assessment than patients whose risk is considered low in terms of their cardio-respiratory and muscular function.

The median duration between the physiological evaluation of patients considered "at risk" before pulmonary resection surgery is 44 (Q1-Q3 29-76) days at Rouen University Hospital, with no significant differences observed between patients who have benefited or not from preoperative rehabilitation. Some teams have even pointed out that there is no difference in survival prognosis in the short or long term between patients who have had an operative delay of more or less 60 or 90 days respectively, which shows the compatibility with the set up a dedicated training course.

As mentioned earlier, the concept of delay has led to extremely dense training for a functionally and cardio-respiratory fragile target population as evidenced by pejorative VO2peak. The density of the training, failing to generate significant physiological stimulation, may increase fatigue or limit adherence to training, especially if it requires movement, and is added to a therapeutic planning including many consultations and further examinations. To date, no study has evaluated the density of preoperative supervised training on pre-surgical benefits.

The objective of this work is to compare the effectiveness of a program of 15 training sessions on VO2peak according to two different densities, namely five times a week over three weeks, or three times a week over five weeks.

lead_sponsor: ADIR Association


type: Other Identifier

title: Posttraumatic Stress Disorder and Quality of Life of Avalanche Survivors From 2014 to 2018, Based on the French North Alpine Avalanche Register: Risk Factor Analysis

acronym: ESPTAvalanche

summary:
The aim of this study is to identify if an avalanche accident has a psychological impact on avalanche victims.

The investigators hypothesize that being exposed to an avalanche could generate enough stress to develop posttraumatic stress symptoms or even more, an authentic posttraumatic stress disorder (PTSD). Additionally, the investigators think that such symptoms might lead to physical and psychological distress in daily life. Lastly, the investigators suppose that a serious traumatism, a complete and/or prolonged burial, the death of a family member or a closed friend could be a potential risk factors to develop PTSD symptoms in avalanche victims. To evaluate post traumatic stress symptoms and the quality of life of avalanche survivors, the investigators use the Impact of Event Scale - Revised and the Short Form 12. These two scales are included in a standardized questionnaire, which is submitted to avalanche victims during a phone call.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Breslau N. The epidemiology of trauma, PTSD, and other posttrauma disorders. Trauma Violence Abuse. 2009 Jul;10(3):198-210. doi: 10.1177/1524838009334448. Epub 2009 Apr 30.

family: Breslau

full_name: Naomi Breslau

given: Naomi

sequence: first

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trauma, Violence, & Abuse

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: The Epidemiology of Trauma, PTSD, and Other Posttrauma Disorders

ReferenceCitation: Thordardottir EB, Valdimarsdottir UA, Hansdottir I, Resnick H, Shipherd JC, Gudmundsdottir B. Posttraumatic stress and other health consequences of catastrophic avalanches: A 16-year follow-up of survivors. J Anxiety Disord. 2015 May;32:103-11. doi: 10.1016/j.janxdis.2015.03.005. Epub 2015 Mar 28.

family: Thordardottir

full_name: Edda Bjork Thordardottir

given: Edda Bjork

family: Valdimarsdottir

full_name: Unnur Anna Valdimarsdottir

given: Unnur Anna

sequence: additional

family: Hansdottir

full_name: Ingunn Hansdottir

given: Ingunn

family: Resnick

full_name: Heidi Resnick

given: Heidi

family: Shipherd

full_name: Jillian C. Shipherd

given: Jillian C.

family: Gudmundsdottir

full_name: Berglind Gudmundsdottir

given: Berglind

journal_name: Journal of Anxiety Disorders

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Parry-Jones B, Parry-Jones WL. Post-traumatic stress disorder: supportive evidence from an eighteenth century natural disaster. Psychol Med. 1994 Feb;24(1):15-27.

ReferenceCitation: Johnsen BH, Eid J, Løvstad T, Michelsen LT. Posttraumatic stress symptoms in nonexposed, victims, and spontaneous rescuers after an avalanche. J Trauma Stress. 1997 Jan;10(1):133-40.

ReferenceCitation: Finnsdottir T, Elklit A. Posttraumatic sequelae in a community hit by an avalanche. J Trauma Stress. 2002 Dec;15(6):479-85.

ReferenceType: derived

ReferenceCitation: Léonard C, Charriau-Perret A, Debaty G, Belle L, Ricard C, Sanchez C, Dupré PM, Panoff G, Bougerol T, Viglino D, Blancher M; Northern French-Alps Emergency Network ("RENAU"). Survivors of avalanche accidents: posttraumatic stress disorder symptoms and quality of life: a multicentre study. Scand J Trauma Resusc Emerg Med. 2021 Jul 19;29(1):96. doi: 10.1186/s13049-021-00912-3.

family: Léonard

full_name: Charlotte Léonard

given: Charlotte

family: Charriau-Perret

full_name: Anaëlle Charriau-Perret

given: Anaëlle

family: Debaty

full_name: Guillaume Debaty

given: Guillaume

family: Belle

full_name: Loïc Belle

given: Loïc

family: Ricard

full_name: Cécile Ricard

given: Cécile

family: Sanchez

full_name: Caroline Sanchez

given: Caroline

family: Dupré

full_name: Pierre-Marie Dupré

given: Pierre-Marie

family: Panoff

full_name: Gregory Panoff

given: Gregory

family: Bougerol

full_name: Thierry Bougerol

given: Thierry

family: Viglino

full_name: Damien Viglino

given: Damien

name: the Northern French-Alps Emergency Network (“RENAU”)

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine


title: Evaluation of Return to Work One Year After a Short Rehabilitation Program for Chronic Non Specific Low Back Pain Patients

summary:
Return to work is one of the essential objectives of functional spinal restoration programs. When the duration of the work stoppage increases, the chances of returning to work become worse. No studies have yet evaluated the value of a short 2-week restoration program.

The purpose of this study is to determine whether a 2-week functional restoration program regains a return-to-work rate similar to longer-term restoration programs at one year post-program.

This retrospective study with prospective referral included 200 patients with non specific chronic low-back pain who participated in a self-care rehabilitation program between May 2018 and May 2019. The program included both physical and educational approaches to dealing with the condition. The duration was two weeks with follow-up at three months.

The main evaluation criterion was to evaluate the return to work rate by telephone at one year post-program. Secondary objectives were to observe return-to-work conditions, absenteeism, recovery time, pain and physical activity at one year post-program and also to observe if there was a possible association between intrinsic/extrinsic factors and return to work

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.

acronym: TRUEGREEN

summary:
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Institut Pasteur de Lille

status_simplified: Ongoing


title: Monitoring of the Bone Free Flaps With Microdialysis

summary: Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. The aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

status: Recruiting

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Procedure


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

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

ReferenceType: background

ReferenceCitation: Suehs CM, Bourdin A. Tapering of Oral Corticosteroids for the Treatment of Asthma. Arch Bronconeumol (Engl Ed). 2021 Feb 17. pii: S0300-2896(21)00054-5. doi: 10.1016/j.arbres.2021.01.029. [Epub ahead of print] English, Spanish.

ReferenceCitation: Suehs CM, Menzies-Gow A, Price D, Bleecker ER, Canonica GW, Gurnell M, Bourdin A; Oral Corticosteroids Tapering Delphi Expert Panel. Expert Consensus on the Tapering of Oral Corticosteroids for the Treatment of Asthma. A Delphi Study. Am J Respir Crit Care Med. 2021 Apr 1;203(7):871-881. doi: 10.1164/rccm.202007-2721OC.

name: Département des Maladies Respiratoires and

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

name: PhyMedExp, Université de Montpellier, Institut National de la Santé et de la Recherche Médicale, Centre National de la Recherche Scientifique, Centre Hospitalier Universitaire Montpellier, Montpellier, France

family: Menzies-Gow

full_name: Andrew Menzies-Gow

given: Andrew

name: Royal Brompton and Harefield National Health Service Foundation Trust, London, United Kingdom

name: Observational and Pragmatic Research Institute, Singapore

family: Price

full_name: David Price

given: David

name: Division of Applied Health Sciences, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom

family: Bleecker

full_name: Eugene R. Bleecker

given: Eugene R.

name: Department of Medicine, University of Arizona, Tucson, Arizona

family: Canonica

full_name: Giorgio Walter Canonica

given: Giorgio Walter

name: Personalized Medicine, Asthma and Allergy Center, Humanitas University and IRCCS Research Hospital, Milan, Italy; and

name: Wellcome Trust–Medical Research Council Institute of Metabolic Science and

family: Gurnell

full_name: Mark Gurnell

given: Mark

name: Cambridge National Institute for Health Research Biomedical Research Centre, University of Cambridge and Addenbrooke’s Hospital, Cambridge, United Kingdom

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

journal_name: American Journal of Respiratory and Critical Care Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Turin - Institutional Research Information System University of Turin

version: publishedVersion

repository_institution: Aberdeen University - Aberdeen University Research Archive

version: submittedVersion

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

repository_normalized: HAL

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

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

ipd_sharing: Yes

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


title: Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.

acronym: SOMNOVENT'

summary:
In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.

In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.

The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Device

status_simplified: Unknown


title: ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List

summary:
In 2014, the "States General of Kidney" have allowed to assess the situation concerning the management of chronic kidney disease on the national territory. Ex-Languedoc-Roussillon has emerged as one of the French regions with a high dialysis / transplant ratio compared to other regions. Disparities in accessibility to the kidney transplant list were also very important. In the ex-Languedoc-Roussillon Region, the number of patients on the renal transplant list was lower than the national average (18.9 vs. 24.1%, respectively, according to the REIN 2015 report).

In 2015, the Regional Health Agency (ARS) ex-Languedoc-Roussillon, has published proposals to improve the healthcare of the patient in chronic end stage renal failure, and accessibility to the national waiting list for renal transplantation (CRISTAL).

To increase accessibility to the national waiting list for renal transplantation by improving the patient's healthcare, our project is based on the creation of a reinforced exchanges connexion between the hospital's nephrology services professionals, dialysis units and liberal nephrologists. This will include having regular meetings between dialysis nephrologists and CHU nephrologists. The proposals for this project were:

to organize multidisciplinary consultation meetings between transplant and dialysis professionals
to set up an exchange platform and communication tools built on the model of telemedicine (COVOTEM), common to the nephrology departments of the University Hospital Center, dialysis units.

This new device for the management of chronic end stage renal failure should increase the number of patients on the national renal transplantation waiting list. It should also make it possible to reduce the time between: firstly, the sending of the pre-registration file to the transplantation at Montpellier University Hospital and registration, and secondly between dialysis and registration.on waiting list.

The investigators hope that this experiment will increase the number of registrations on the National Kidney Transplantation Waitlist (CRISTAL). The implementation of this innovative tool should facilitate communication between nephrologists dialysis centers and nephrologists of CHU Montpellier, and accelerate the process of registration on the National Kidney Transplantation Waitlist.

If this platform proves to be easy to use and if the project's evaluation criteria show significant results, the platform could then be used to monitor patients in post-transplantation. Indeed, the data of patients who perform an alternating follow-up would be available for the referring nephrologists and for the transplant center. The further development of the platform would allow to create a mode of communication via this platform.


title: Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant

summary: It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

lead_sponsor: CHU de Reims


type: EudraCT Number

title: Comparison of Maximum Blood Concentrations of Colchicine Between Responders and Non-responders to Colchicine Treatment During Gout Flare

acronym: COMpARE

summary:
Gout, secondary to sodium urate crystal deposition, is responsible of recurrent inflammatory painful flares. Efficacy of colchicine which is the first line drug for the treatment and prophylaxis of gout flare varies and only half of treated patients experience good response. This study aims to optimize colchicine prescription for the treatment and prophylaxis of gout flare.

Current data suggest that efficiency of colchicine relies on its maximum blood concentration (Cmax).

In this study, the investigators hypothesize that responders to colchicine treatment have higher colchicine Cmax than non-responder patients following the recommended dose regimen (1 mg then 0.5 mg 1 hour later).

The individual pharmacokinetics (PK) of colchicine remains poorly investigated while the assessment of individual drug metabolisms can be performed.

The hypothesis of this study stands that several factors contribute to the variability of colchicine Cmax. The analysis of individual PK profile and a well-characterized metabolism of colchicine will permit a personalized treatment regimen for the treatment and prophylaxis of gout flares.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Lariboisière-Service de Rhumatolologie

intervention_type: Drug


location_facility: APHP - Groupe Hospitalier Pitié-Salpêtrière

source: euctr

title: First-line Chemotherapy With Temozolomide Alone for Non-enhancing Adult Brainstem Gliomas, With a Diffuse Subtype and Showing Clinical and/or Radiological Infiltrative Pattern of Progression

summary: This phase 2 study is a prospective cohort study. Chemotherapy alone will be proposed to adult patients suffering from a "low grade" brainstem glioma subtype showing infiltrative, non-threatening clinico-radiological progression. Patients will receive temozolomide at a monthly standard dose of 150-200 mg/m2/j J1-J5, will be clinically evaluated every month and will undergo radiological evaluation every 2 months. The duration of treatment will be 12 months. Then, the patients will be followed-up until progression, with clinical evaluations and MRI performed every 2-3 months. At the time of recurrence, treatment with focal radiation therapy will be administered (54 Gy in classical fractions).


title: Observational Study of Epigastric Symptoms Chronicles, the Rise of the Line of Clips and Their Management in Obese Patients One Year Later Sleeve Gastrectomy

acronym: POST-SLEEVE

summary: This is a single institution study. All patients, one year after sleeve gastrectomy will be included. All will have a CT scan looking for clip ascent. For patients with chronic gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed. Those symptoms appeared at least 6 months after the surgery. A second consultation is done one year after. The aim of the study is to correlate clip ascent, pyrosis proved by ph-metry and epigastric symptoms after sleeve gastrectomy. The demographic data collection confirms the definition of clip ascent, define its frequency, and look for correlation with the median weight loss.

status: Unknown status


title: Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.

summary:
Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.

There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.

primary_purpose: Basic Science

lead_sponsor: Versailles Hospital


title: EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter

acronym: EVANI

summary:
The aim is to evaluate the electrocardiogram quality signal of the Cardioskin device and compare it with a Holter signal. For that, volunteers subjects will wear the Cardioskin and Holter, non-simultaneously, for about 24 hours.

This study is open, and will be carried out according to a cross plan. The trial will include approximately 36-40 subjects between 18 and 70 years old.

lead_sponsor: BioSerenity

lead_sponsor_type: industriel


title: Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients

acronym: ICARE

summary:
Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.

Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.

It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.

ReferenceCitation: Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

ReferenceCitation: Loon FHJV, Puijn LAPM, Houterman S, Bouwman ARA. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine (Baltimore). 2016 Apr;95(16):e3428. doi: 10.1097/MD.0000000000003428.

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


title: Endometriosis of the Recto-sigmoid: MRI Criteria Predictive of Shaving or Segmental Resection

summary: Evaluate MRI criteria predictive of the type of surgery to be performed for an "in sano" resection of endometriotic involvement of the recto-sigmoid by a resection without opening of the rectal mucosa ("shaving") versus a segmental resection.

lead_sponsor: Hospices Civils de Lyon

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


title: Single Administration of TOLVAptan at a Dosage Used in the Treatment of Hyponatremia: Changes in THIRST and Water Balance in Healthy Volunteers

acronym: TOLVATHIRST

summary:
Tolvaptan is a new drug that specifically antagonizes the V2-receptor of antidiuretic hormone (ADH) and leads to water diuresis: During acute administration of tolvaptan, the main fear is to induce a too fast increase in plasma sodium concentration and in turn brain damageHowever, the tolvaptan-induced increase in plasma sodium concentration is expected to stimulate thirst, preventing major negative water balance.

The investigators hypothesize that tolvaptan-induced increase in plasma osmolality (and sodium concentration) is dependent of thirst adaptation that is influenced by physiological factors, namely age and sex. To address the effect of a single oral administration of tolvaptan at a dosage used during hyponatremia (15 mg) under free water access in healthy volunteers. Primary outcome will be the maximal change in serum sodium concentration within the 6 hours following tolvaptan administration.

study_start_date_type: Anticipated

ipd_sharing_description: IPD underlying published results


title: Follow-up of Pulmonary Toxicity by Respiratory Functional Tests of Patients Treated With Dynamic Cancer ARCtherapy for Bronchopulmonary Cancer.

acronym: TEFRARC

summary: assess the consequences of low doses of radiation delivered by the volumetric radiotherapy, on the respiratory capacity of patients treated for bronchopulmonary carcinoma, by a follow up of functional respiratory exploration.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer

acronym: Cyto-chip 2

summary: Epithelial ovarian carcinoma (EOC) is one of the main cause of death from cancer in women in the Western world. It is often diagnosed at an advanced stage and the disease remains confined to the peritoneal cavity for much of its natural history. Despite a high rate of response to first-line therapy, about 20% of EOC are naturally resistant to platinum and about 2/3 of patients with initial response will recur within 5 years. Most tumour recurrences will develop resistance to systemic platinum over time. The prognosis of these patients with persistent or recurrence disease remains poor despite salvage therapy including alternative systemic chemotherapy and further cytoreductive surgery (CRS). Since twenty years, centers have pursued comprehensive CRS combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the management of peritoneal surface malignancies (PSM). This combined approach is the standard of care for the management of some rare peritoneal disease such as pseudomyxoma peritonei or peritoneal mesothelioma. EOC should be an ideal target for this loco-regional treatment, as most of its evolution remains confined to intraperitoneal cavity and because of its sensitivity to chemotherapy. Intraperitoneal chemotherapy has been shown to have significant efficacy in frontline EOC in 3 large randomized studies. Recently, French clinical guidelines have been edited to recommend CRS+HIPEC in patients with ovarian, tubal or primitive carcinomatosis FIGOI IIIC, initially not resectable (Grade B). HIPEC adds some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and, the deliverance immediately following CRS, avoiding the problem of "cancer cell entrapment" by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents to all sites. The use of HIPEC for EOC was reported into relatively small case-series from single institutions. Results from a single centre cannot be extrapolated to other centres because of the heterogeneity of patient's selection and HIPEC techniques.


title: Study of the Association Between a Peri-traumatic Dissociation State and the Occurrence of Post-traumatic Stress Syndrome After Severe Trauma Requiring General Anesthesia

acronym: DIStress-AG

summary:
Patients will be selected after studying clinical records.Patients who had general anesthesia due to an injury related to severe trauma within 6 to 12 months prior to inclusion will be included.

Three self-survey will be completed by the patient: PDEQ, PCL-5 and a demographic questionnaire. According to the PDEQ and PCL-5 scores, an association between a peri-traumatic dissociation state and a post-traumatic stress disorder can be established.

primary_purpose: Prevention

intervention_type: Diagnostic Test


title: Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients

acronym: NEMOLOC

summary: This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Stimulation cérébrale Profonde et Empreinte Tissulaire : Une Nouvelle stratégie Pour la Recherche Biologique in Vivo Dans la Maladie de Parkinson, Les TOC, la Dystonie, le Tremblement Essentiel et le Syndrome Gilles de la Tourette.

acronym: BTI

summary:
This exploratory study aims to validate the collection and analysis of brain tissue imprints during the DBS by using a CE marked Medical Device in patients presenting one of the following five disorders: Parkinson's disease (PD), essential tremor (ET), dystonia (DYS), Obsessive compulsive disorder (OCD) and Tourette Syndrome (TS).

The Brain Tissue Imprint project is focused on the DBS surgical procedure, which constitutes an appropriate method to collect brain tissue imprints by taking advantage of the direct and transitory contact at the extremity of the dilator with adjacent brain tissue. Indeed, during this step, micro-fragments of brain material spontaneously adhere to the dilator tip. It is this imprinting process that allows to collect what is defined as "brain tissue imprints. This approach is part of the standard surgical procedure of the SCP without major change or complications.

ReferenceCitation: Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6.

ReferenceCitation: Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. Review.

ReferenceCitation: Holtzheimer PE, Mayberg HS. Deep brain stimulation for psychiatric disorders. Annu Rev Neurosci. 2011;34:289-307. doi: 10.1146/annurev-neuro-061010-113638. Review.

ReferenceCitation: Hariz M, Blomstedt P, Zrinzo L. Future of brain stimulation: new targets, new indications, new technology. Mov Disord. 2013 Nov;28(13):1784-92. doi: 10.1002/mds.25665. Epub 2013 Oct 7. Review.

ReferenceCitation: Fontaine D, Lanteri-Minet M, Ouchchane L, Lazorthes Y, Mertens P, Blond S, Geraud G, Fabre N, Navez M, Lucas C, Dubois F, Sol JC, Paquis P, Lemaire JJ. Anatomical location of effective deep brain stimulation electrodes in chronic cluster headache. Brain. 2010 Apr;133(Pt 4):1214-23. doi: 10.1093/brain/awq041. Epub 2010 Mar 17.

ReferenceCitation: Laxton AW, Tang-Wai DF, McAndrews MP, Zumsteg D, Wennberg R, Keren R, Wherrett J, Naglie G, Hamani C, Smith GS, Lozano AM. A phase I trial of deep brain stimulation of memory circuits in Alzheimer's disease. Ann Neurol. 2010 Oct;68(4):521-34. doi: 10.1002/ana.22089.

ReferenceCitation: Boëx C, Seeck M, Vulliémoz S, Rossetti AO, Staedler C, Spinelli L, Pegna AJ, Pralong E, Villemure JG, Foletti G, Pollo C. Chronic deep brain stimulation in mesial temporal lobe epilepsy. Seizure. 2011 Jul;20(6):485-90. doi: 10.1016/j.seizure.2011.03.001. Epub 2011 Apr 12.

ReferenceCitation: Lozano AM, Giacobbe P, Hamani C, Rizvi SJ, Kennedy SH, Kolivakis TT, Debonnel G, Sadikot AF, Lam RW, Howard AK, Ilcewicz-Klimek M, Honey CR, Mayberg HS. A multicenter pilot study of subcallosal cingulate area deep brain stimulation for treatment-resistant depression. J Neurosurg. 2012 Feb;116(2):315-22. doi: 10.3171/2011.10.JNS102122. Epub 2011 Nov 18.

ReferenceCitation: Torres N, Chabardes S, Piallat B, Devergnas A, Benabid AL. Body fat and body weight reduction following hypothalamic deep brain stimulation in monkeys: an intraventricular approach. Int J Obes (Lond). 2012 Dec;36(12):1537-44. doi: 10.1038/ijo.2011.271. Epub 2012 Feb 21.

ReferenceCitation: Luigjes J, van den Brink W, Feenstra M, van den Munckhof P, Schuurman PR, Schippers R, Mazaheri A, De Vries TJ, Denys D. Deep brain stimulation in addiction: a review of potential brain targets. Mol Psychiatry. 2012 Jun;17(6):572-83. doi: 10.1038/mp.2011.114. Epub 2011 Sep 20. Review.

ReferenceCitation: Benabid AL, Chabardes S, Mitrofanis J, Pollak P. Deep brain stimulation of the subthalamic nucleus for the treatment of Parkinson's disease. Lancet Neurol. 2009 Jan;8(1):67-81. doi: 10.1016/S1474-4422(08)70291-6. Review.

ReferenceCitation: Zaccaria A, Bouamrani A, Chabardès S, El Atifi M, Seigneuret E, Lobrinus JA, Dubois-Dauphin M, Berger F, Burkhard PR. Deep brain stimulation-associated brain tissue imprints: a new in vivo approach to biological research in human Parkinson's disease. Mol Neurodegener. 2016 Jan 28;11:12. doi: 10.1186/s13024-016-0077-4.

ReferenceCitation: Crecelius A, Götz A, Arzberger T, Fröhlich T, Arnold GJ, Ferrer I, Kretzschmar HA. Assessing quantitative post-mortem changes in the gray matter of the human frontal cortex proteome by 2-D DIGE. Proteomics. 2008 Mar;8(6):1276-91. doi: 10.1002/pmic.200700728.

ReferenceCitation: Mexal S, Berger R, Adams CE, Ross RG, Freedman R, Leonard S. Brain pH has a significant impact on human postmortem hippocampal gene expression profiles. Brain Res. 2006 Aug 23;1106(1):1-11. doi: 10.1016/j.brainres.2006.05.043. Epub 2006 Jul 14.

ReferenceCitation: Chariot P, Witt K, Pautot V, Porcher R, Thomas G, Zafrani ES, Lemaire F. Declining autopsy rate in a French hospital: physician's attitudes to the autopsy and use of autopsy material in research publications. Arch Pathol Lab Med. 2000 May;124(5):739-45.

lead_sponsor: University Hospital, Grenoble


title: The Visuo-attentional Mediator of Social Facilitation

acronym: VAMOS

summary:
Social psychology has long established that the mere presence of others influences the investigator's individual behavior and performance. "Social facilitation" refers to any improvement or deterioration of performance due to the presence of others. For more than a century, social psychology has acquired a solid knowledge of the principles governing this fundamental form of social influence.

But the underlying mechanism of social facilitation remains debated, as behavior alone cannot identify it with certainty. This major unresolved problem makes it particularly difficult to translate laboratory results on social facilitation into real applications in areas such as school or work, where others are ubiquitous. The purpose of this study will therefore be to identify the mediator of social facilitation.

location_facility: Centre de Recherche en Neuroscience de Lyon

intervention_type: Behavioral


title: Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life

acronym: ACTISEP

summary: This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.


title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study

acronym: IMAGE AIT

summary: The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.

design_allocation: Non-Randomized

primary_purpose: Diagnostic


title: General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments

acronym: ATB-IU

summary: Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer


title: Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

summary: The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)

ReferenceCitation: Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(®) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.

name: Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France;

name: Federation of Translational Medicine EA 3070, University of Strasbourg, Strasbourg, France;

family: Khayath

full_name: Naji Khayath

given: Naji

name: Clinics of Immuno-Allergology, CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium;

family: Doyen

full_name: Virginie Doyen

given: Virginie

name: Biocluster des Haras, ALYATEC®, Strasbourg, France;

family: Gherasim

full_name: Alina Gherasim

given: Alina

family: Radu

full_name: Carmen Radu

given: Carmen

family: Choual

full_name: Ibrahim Choual

given: Ibrahim

family: Beck

full_name: Nicole Beck

given: Nicole

family: Jacob

full_name: Audrey Jacob

given: Audrey

family: Schoettel

full_name: Florian Schoettel

given: Florian

name: François-Rabelais University, Tours Cedex, France

family: Vecellio

full_name: Laurent Vecellio

given: Laurent

family: Domis

full_name: Nathalie Domis

given: Nathalie

family: de Blay

full_name: Frédéric de Blay

given: Frédéric

journal_name: Journal of Asthma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC® in mite allergic subjects with asthma

ReferenceCitation: Gherasim A, Jacob A, Schoettel F, Domis N, de Blay F. Efficacy of air cleaners in asthmatics allergic to cat in ALYATEC(®) environmental exposure chamber. Clin Exp Allergy. 2020 Feb;50(2):160-169. doi: 10.1111/cea.13511. Epub 2019 Nov 6.

name: ALYATEC<sup>®</sup> Environmental Exposure Chamber 1 place de l'Hôpital Strasbourg France

name: Chest Diseases Department Strasbourg University Hospital Strasbourg France

name: Federation of translational medicine EA 3070 University of Strasbourg Strasbourg France

family: Blay

full_name: Frederic Blay

given: Frederic

journal_name: Clinical & Experimental Allergy

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Efficacy of air cleaners in asthmatics allergic to cat in ALYATEC ® environmental exposure chamber

lead_sponsor: Alyatec


title: 4DFlow Magnetic Resonance Imaging in Patients With Pulmonary Hypertension Associated With Congenital Heart Disease

summary:
Congenital heart disease is the most common congenital anomaly. The life expectancy of children with congenital heart disease has increased considerably in recent years.

Nevertheless, the evolution of these patients is marked by an increased risk of complications. Arrhythmias, heart failure, pulmonary arterial hypertension (PAH) and endocarditis may be promoted by the absence or delay of management in childhood, by residual lesions or post-operative cardiac scars and by the presence of prosthetic materials.

PAH is a common complication of congenital heart disease, especially in non-operated shunts.

PAH corresponds to an increase in pulmonary vascular resistance and mean pulmonary arterial pressure that becomes greater than 25mmHg at rest, leading to right ventricular failure and ultimately to the patient's death.

Eisenmenger's syndrome corresponds to a non-reversible pulmonary arterial hypertension with a left-right shunt initially left open, then right-left secondary to the increase in pulmonary vascular resistance, leading to cyanosis, polycythemia and multivisceral involvement. It is the most advanced form of PAH with congenital heart disease.

PAH will be suspected during echocardiographic follow-up of any patient with congenital heart disease, on the analysis of the velocity of tricuspid and/or pulmonary regurgitation flow.

Echocardiography allows the monitoring of the VD (right ventricle) function, which is the major prognostic element in PAH. Cardiac catheterization is systematically recommended and remains the gold standard to confirm the diagnosis of PAH, establish its pathophysiology and prognosis but also for the follow-up under medical treatment of these patients in tertiary centres every 6 months. Although this tool is the gold standard, rigorously performed, it remains an invasive examination often poorly experienced by patients.

4D Flow MRI is a promising imaging that allows the acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information in a single step with 2D (only 8 minutes extra), in free breathing and totally autonomous mode. Thus, at the same time as the realization of a 2D MRI, essential for the diagnosis and follow-up of PAH, with an additional 8 minutes for 4D flow, the investigators could have additional fundamental information on pulmonary cardiac output but also prognostic markers of right ventricular dysfunction turning dramatic in pulmonary vascular disease.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma

acronym: UMATH

summary: Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

lead_sponsor: University Hospital, Tours

location_facility: Emergency Medical Service, University Hospital, Tours


title: Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study

acronym: PSMA

summary:
A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery.

The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases.

Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can:

To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed.

Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.

location_facility: Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon


title: Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

acronym: MEDIA

summary: The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).

time_perspective: Other

lead_sponsor: Tmm Software


title: Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

acronym: ABBA

summary: Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.


title: Pronostic Study of Biomarkers in Acute Decompensation of Pulmonary Hypertension

acronym: PROPULS

summary: The main objective of this study is to analyze the survival of a cohort of patients admitted for acute decompensation of pulmonary arterial hypertension or postembolic pulmonary hypertension and to establish the prognostic value of biomarkers.


title: Prognostic Factors of Carbon Monoxide-induced Coma Treated by Hyperbaric Oxygen: a Retrospective Study

acronym: Coma-CO

summary: The primary objective of the study is to determine prognostic factors for hospital-mortality following carbon monoxide (CO)-induced coma. The secondary objective is to determine prognostic factors of CO related cognitive sequelae, at the time of hospital discharge.

ReferenceCitation: Resche-Rigon M, White IR. Multiple imputation by chained equations for systematically and sporadically missing multilevel data. Stat Methods Med Res. 2018 Jun;27(6):1634-1649. doi: 10.1177/0962280216666564. Epub 2016 Sep 19.

location_facility: Intensive Care Unit, Raymond Poincaré hospital


title: Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.

acronym: HYPNOFACE

summary:
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.

The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.


title: Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care

acronym: MUSANX

summary: The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness

primary_purpose: Supportive Care

lead_sponsor: Nantes University Hospital


acronym: REVOLUMAB

title: A Phase II Study From the POLA National Network of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas

summary:
Immune checkpoint blockade therapies targeting the immunomodulatory effect of cytotoxic T-lymphocyte antigen (CTLA-4) and programmed cell death-1/ Programmed death-ligand 1 (PD-1/PD-L1) have recently demonstrated survival benefit and durable response in phase III trials in several human cancers, especially in tumors that bear high mutation load and/or tumor-associated neoantigen signatures. The aim of these treatments is to restore effector T-cell function and antitumor activity, which could be enhanced in the context of high mutational/neoantigen load. In Isocitrate DeHydrogenase mutated High Grade Gliomas (IDHm HGGs), acquired resistance to alkylating chemotherapy frequently results from the inactivation of mismatch-repair (MMR) proteins which in turn leads to the acquisition of a hypermutator phenotype. These findings suggest that at least in a subset of recurrent IDHm HGGs immune checkpoint blockade therapies may be particularly effective. IDHm HGGs most frequently occur in young adults. The first line treatment consists of maximal safe surgical resection followed by radiotherapy and adjuvant alkylating chemotherapy (Temozolomide or Procarbazine-CCNU-Vincristine regimen (PCV)). Despite these treatments, most IDHm HGGs recurred in few years. There is no standard of care at recurrence and the median overall survival after it is less than 3 years.

The investigators make the hypothesis that treatment with the anti-PD-1 monoclonal antibody Nivolumab will improve 24 weeks progression-free survival in IDHm HGGs that have recurred after initial treatment with radiotherapy and alkylating chemotherapy.


title: Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism

summary:
The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.

The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.

lead_sponsor: Hôpital le Vinatier


title: Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD

acronym: CONvEX

summary:
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.

However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.

Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.

Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.

The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.


title: Epileptiform Activity During REM Sleep in Alzheimer's Disease

acronym: EREMAD

summary: Recent clinical data showed that patients with Alzheimer Disease (AD) might present epilepsy at early stages of the disease (Cretin et al., 2016, Vossel et al., 2016). In mice models of Alzheimer disease, preclinical researchers observed an increase of epileptic events during Rapid Eye Movement (REM) sleep, which is very unusual. This study aims at testing if patients with AD present an exacerbation of epileptic events during REM sleep, which could constitute an early biomarker of the disease. Investigators will evaluate the incidence of epilepsy during each sleep stage in 40 patients with early or moderate forms of AD and in 40 healthy subjects. Investigators will also look for a link between epilepsy during sleep in AD participants and memory performances, brain damage (by using MRI scans) and in the case of patients, the phenotype of the Apolipoprotein E(ApoE) gene.

lead_sponsor: University Hospital, Toulouse


title: High B Value Diffusion and Stroke

acronym: HBS

summary: This study will include 100 stroke patients with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously. Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system. In this project the investigators hypothesize that diffusion MRI at high and ultra-high b-values could be sensitive enough to quantify selective neuronal loss in the rescued penumbra and to study its relationship with the initial hypoperfusion and its impact in terms of clinical recovery.

lead_sponsor: University Hospital, Bordeaux


title: Dry Eye Syndrome Description During Cataract Surgery, With Multimodal Analysis of the Ocular Surface

summary:
The main objective is to describe the characteristics of dry eye syndrome before and after surgery at one month of cataract surgery, using a multimodal analysis of the ocular surface.

The secondary objectives are to evaluate:

Predictive factors of dry eye syndrome during cataract surgery:
The characteristics of dry eye syndrome
Implications for the patient's quality of life

lead_sponsor: University Hospital, Clermont-Ferrand


title: Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry

acronym: AVOCETTE

summary: This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

lead_sponsor: University Hospital, Caen


title: Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)

acronym: CEF-IMPACT

summary: The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study

acronym: Plantar-block

summary:
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.

Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.

This study aims to determine the quality of deambulation following hallux valgus surgery.

Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.

Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.

Consenting patients will be randomized the day of surgery to one of those two groups :

Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)

All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.

During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.

Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.

Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.

Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.

lead_sponsor: University Hospital, Montpellier


title: Non Invasive Evaluation of Muscle Hypoxia in Chronic Obstructive Pulmonary Disease Patient

acronym: EVANIMUS

summary:
Peripheral muscle oxidative function is altered in COPD(chronic obstrutive pulmonary disease) patients. Multiple factors could contribute to this dysfunction including chronic hypoxia and deconditioning (sedentarity).

The evaluation of mitochondrial function is based on invasive method (muscle biopsy and in vitro respirometry) or magnetic resonance spectroscopy limited to small muscle groups. Recently, a non invasive method has been described using Near InfraRed Spectroscopy (NIRS). During arterial occlusion, muscle deoxygenation is only dependent of local oxygen consumption. The time constant recovery (k) of the deoxygenation during repeated ischemia periods has been shown to be correlated to measurements of maximal mitochondrial capacity.

k is lower in COPD patients compared to smokers without bronchial obstruction. However, the influence of arterial hypoxia has never been studied precisely, no more than the confounding effect of deconditioning on k.

So , the aim is to compare k in COPD patients with chronic hypoxemia (treated with long term oxygenotherapy, LTOT+ group) and patients without hypoxia, matched for their physical activity (LTOT- group).

The hypothe is that k will be lower in LTOT+ group compared to LTOT- group and that short term O2 supplementation will improve it, which would suggest a muscle hypoxia. By contrast, O2 should not influence k in LOT- group, in whom it is mainly determined by muscle conditioning.


title: Phase I/II Study of the Decrease of Length of Stereotactic Body Radiation Therapy in the Treatment of Stage IA - IB Non Small Cell Lung Cancer (T1N0M0 or T2aN0M0)

acronym: PNEUMOFRAC

summary:
Purpose :

Non small cell lung cancer (NSCLC) is among the most common cancers in the werstern world. Patients with stage I have the most satisfactory outcomes. The gold standard for treatment is still surgery, but this approach has recently been challenged by hypofractionnated stereotactic body radiation therapy (SBRT). Therefore, for patients who are not eligible for surgery due to their significant co-morbidity, or for those who refuse surgical resection, stereotactic radiotherapy is an efficient practical alternative. SBRT is well tolerated and efficient, in fact local control rate at 3 years reaches more than 90%. Most of guidelines recommand a dose between 48 and 60 Gy delivered in 3 at 8 fractions and 3 weeks. Biological effect depends on the dose distribution in time and decreases when the number of fractions or length of radiation treatment increase. Decreasing the length of treatment and the interval between fractions may improve efficiency of treatment and local control rate. Moreover, it may improve quality of life of patients. Nevertheless, an evaluation of safety of such shorter treatment course, with a phase I-II clinical study is needed.

lead_sponsor: Centre Paul Strauss

intervention_type: Radiation


title: Determination of the Prognostic Value Serum Concentration of Indoxyl Sulfate During Acute Kidney Injury in Septic Shock Patients: TOX-AKI Study

acronym: TOX-AKI

summary: The development of acute kidney injury (AKI) during septic shock is frequent and is associated with a high mortality rate. The reason of this increased mortality despite the use of renal replacement therapy is still unknown. The deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. Among those solutes, indoxyl sulfate (IS) is associated with the development of cardiovascular complications and impairment of immune response. The role of uremic toxins and particularly IS in the prognostic of septic kidney injury is unknown. The investigators propose to analyze the relation between the serum concentration of IS and the mortality of patients hospitalized for a septic shock who developed an AKI.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV

summary:
Adapted athletic activity has shown benefits in patients with certain chronic diseases, including improving fatigue and pain in patients with cancer, and improving the symptoms of severe depression.

Among Patients Living with Human Immunodeficiency Virus (PLHIV), sport appears to be less common than for people who do not live with HIV. In fact, 44% of PLHIV in a Swiss cohort (10,500 patients) were inactive in 2014, whereas this percentage was 26% in the general population in Switzerland. We did not find any French data on the prevalence of sports activity among PLHIV.

The benefits of sport in PLHIV are numerous: meta-analyzes on interventional studies of aerobic and resistance exercises show a significant improvement in maximum oxygen consumption, muscle strength, percentage of body fat, quality of life and symptoms of depression. An improvement in cognitive function was noted in a randomized study. An Iranian randomized study of 2017 showed an improvement in the CD4 count, after 8 weeks of resistive exercise, but two meta-analyzes of 2016 and 2017 did not find a significant change in CD4 or viral load with physical exercise.

On the other hand, several studies have shown that sports practice improves self-esteem. In addition, an Australian randomized study in 2006 showed an improvement in self-efficacy in PLHIVs after a six-month exercise (aerobic and resistance) program. Furthermore, self-esteem (defined as positive self-esteem) is a factor facilitating adherence to antiretroviral therapy.

The objective of this descriptive study is to evaluate the prevalence of sports activity in a French adult population infected with HIV and to seek an association with self-esteem. In addition, the investigators will look for an association between sport and fatigue, pain, sleep, lymphocyte T CD4 cell levels, viral load.

lead_sponsor: Centre Hospitalier le Mans


ReferenceCitation: Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quémeneur T, Blanchard-Delaunay C, Godmer P, Puéchal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

family: Pagnoux

full_name: Christian Pagnoux

given: Christian

family: Karras

full_name: Alexandre Karras

given: Alexandre

family: Khouatra

full_name: Chahera Khouatra

given: Chahera

family: Aumaître

full_name: Olivier Aumaître

given: Olivier

family: Cohen

full_name: Pascal Cohen

given: Pascal

family: Maurier

full_name: François Maurier

given: François

family: Decaux

full_name: Olivier Decaux

family: Ninet

full_name: Jacques Ninet

given: Jacques

family: Gobert

full_name: Pierre Gobert

given: Pierre

family: Quémeneur

full_name: Thomas Quémeneur

given: Thomas

family: Blanchard-Delaunay

full_name: Claire Blanchard-Delaunay

given: Claire

family: Godmer

full_name: Pascal Godmer

family: Puéchal

full_name: Xavier Puéchal

given: Xavier

family: Carron

full_name: Pierre-Louis Carron

given: Pierre-Louis

family: Hatron

full_name: Pierre-Yves Hatron

given: Pierre-Yves

family: Limal

full_name: Nicolas Limal

given: Nicolas

family: Hamidou

full_name: Mohamed Hamidou

given: Mohamed

family: Ducret

full_name: Maize Ducret

given: Maize

family: Daugas

full_name: Eric Daugas

given: Eric

family: Papo

full_name: Thomas Papo

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

family: Mahr

full_name: Alfred Mahr

given: Alfred

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Mouthon

full_name: Luc Mouthon

given: Luc

title: Rituximab versus Azathioprine for Maintenance in ANCA-Associated Vasculitis

ReferenceCitation: Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.

ReferenceCitation: Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.

ReferenceCitation: Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169.

ReferenceCitation: Samson M, Puéchal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Ruivard M, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Long-term follow-up of a randomized trial on 118 patients with polyarteritis nodosa or microscopic polyangiitis without poor-prognosis factors. Autoimmun Rev. 2014 Feb;13(2):197-205. doi: 10.1016/j.autrev.2013.10.001. Epub 2013 Oct 23.

title: Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

summary: The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.


title: Analysis of the Nasal Mucosal Immune Response in HIV Infection

acronym: HYSOPE

summary: The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the healthy control population of Milieu Interieur;

ipd_sharing_description: Data will be entered electronically via a web browser in Electronic Case Report Form Data will be analysed by Pasteur Institute of Paris with the biological results

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Association Between Toe-brachial Index and Coronary Calcification in Asymptomatic Patients With Type 1 and Type 2 Diabetes Mellitus

acronym: ACCoDiab

summary:
Diabetes is not a coronary risk equivalent, despite cardiovascular disease is the most common cause of death in diabetes. So, to identify diabetic patients at high cardiovascular risk is necessary. Coronary artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. But, cornary artery calcification score is expensive and exposes patients to radiation. So, it cannot be used for large-scale screening. It could be interesting to identify the predictive factors of coronary artery calcification score.

Toe-brachial index is relevant in diabetic patients for the screening of peripheral arterial disease, and predicts cardiovascular events.

The aim of this study is to evaluate the association between toe-brachial index and coronary artery calcification score in asymptomatic patients with type 1 or 2 diabetes. The hypothesis is that toe-brachial index is associated with high coronary artery calcification score. It could be performed first to identify patients who require a coronary artery calcification score. It measurement is reliable, fully automated, repoducible ans cost-effectiveness.

This is a cross-sectional study, with restrospective data collection. All patients addressed to a one-day hospitalization to assess cardiovascular comorbidities are eligible.

Data are collected in patients'medical records. Clinical, biological and imaging data were collected previously during their one-day hospitalization

location_facility: Diabetology department, Pitié-Salpêtrière hospital


title: Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency

acronym: SSNHL

summary: The roles of thrombophilia and cardiovascular risk factors in sudden sensorineural hearing loss (SSNHL) remain controversial. Cochlear micro-thrombosis has been hypothesized as a possible pathogenic mechanism of SSNHL. The objective was thus to measure the levels of markers of macrovascular thrombosis and microvascular risk factors

ReferenceCitation: Callebert J, Esteve JM, Hervé P, Peoc'h K, Tournois C, Drouet L, Launay JM, Maroteaux L. Evidence for a control of plasma serotonin levels by 5-hydroxytryptamine(2B) receptors in mice. J Pharmacol Exp Ther. 2006 May;317(2):724-31. Epub 2006 Feb 3.

ReferenceCitation: Brand T, Anderson GM. The measurement of platelet-poor plasma serotonin: a systematic review of prior reports and recommendations for improved analysis. Clin Chem. 2011 Oct;57(10):1376-86. doi: 10.1373/clinchem.2011.163824. Epub 2011 Aug 22. Review.

family: Brand

full_name: Theresa Brand

given: Theresa

name: Department of Laboratory Medicine, Yale University School of Medicine, New Haven, CT

family: Anderson

full_name: George M Anderson

given: George M

journal_name: Clinical Chemistry

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: The Measurement of Platelet-Poor Plasma Serotonin: A Systematic Review of Prior Reports and Recommendations for Improved Analysis

ipd_sharing_description: it will be decided at completion of patient recruitement

lead_sponsor: Hopital Lariboisière


title: Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF

acronym: PHENOSAX

summary: Sleep apnea is classically divided into obstructive and central apnea, according to the persistence or otherwise of respiratory movements and the existence or not of pharyngeal collapse during apnea. However, there is evidence to suggest that some mechanisms are common to both types of apnea. Although the pathophysiology of obstructive apnea has been the subject of much work and now seems fairly well known, there is much less data on central apnea. These apneas can occur in different comorbid contexts. They are more frequently present in patients with heart failure, regardless of the etiology, and are associated with an adverse prognosis. The investigators hypothesize that the physiopathology of adult central apnea syndrome involves, in addition to ventilatory control abnormalities, upper airway abnormalities (VAS). The objective is to study the pathophysiology of central SAS, by first comparing the collapse of VAS of central apneic patients to those of patients with simple snoring or obstructive sleep apnea. In a second step, the investigators will analyze the cardiorespiratory coupling and will establish a map of the respiratory neural network in patients with central apnea. The investigators will focus their study on patients with central SAS (with preserved systolic heart function) due to the epidemiology of SAS.


title: Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo

acronym: IVOXY

summary:
De novo acute hypoxemic respiratory failure (AHRF) is associated with high overall mortality, which increases significantly with the use of orotracheal intubation. High flow nasal canula (HFNC) has turned to be the first line non-invasive oxygenation strategy aiming to avoid intubation. One of the main factors worsening lung injury and increasing mortality in invasively ventilated patients is a too high tidal volume (TV) delivered by the ventilator. Consistent data suggest that such an aggravation of respiratory lesions may occur during spontaneous ventilation if TV is too large. This phenomenon is called Patient self-inflicted lung injury (P-SILI). The effect of TV on the outcome of patients with de novo AHRF under HFNC has never been evaluated since TV is not easily accessible in patients under HFNC. Investigators hypothesized that a large TV during HFNC has an impact on the outcome. TV will be measured using chest Electrical Impedance Tomography (EIT). To calibrate the EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. Thus, EIT signal can be used to calculate TV during HFNC since it remains reliable even when the positive expiratory pressure changes.

A secondary objective is to quantify a respiratory distress index. This quantification will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle Investigators want to be able to evaluate up to 6 predictors of HFNC failure in this research with an effect size of 0.15, α risk of 0.05, and a power of 0.8. A number of 55 participants is required. Investigators plan to include 60 patients due to potential withdrawal of consent and/or unusable data.

ReferenceCitation: Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35.

ReferenceCitation: Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. Epub 2001 Oct 16.

ReferenceCitation: Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91.

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Mercat

full_name: Alain Mercat

given: Alain

family: Girault

full_name: Christophe Girault

given: Christophe

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Prat

full_name: Gwénael Prat

given: Gwénael

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Nseir

full_name: Saad Nseir

given: Saad

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Wittebole

full_name: Xavier Wittebole

family: Chevalier

full_name: Stéphanie Chevalier

family: Herbland

full_name: Alexandre Herbland

given: Alexandre

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Tonnelier

title: High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure

ReferenceCitation: Carteaux G, Millán-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.

ReferenceCitation: Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.

ReferenceCitation: Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.

ReferenceCitation: Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.

ReferenceCitation: Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.

ReferenceCitation: Hammer J, Newth CJ. Assessment of thoraco-abdominal asynchrony. Paediatr Respir Rev. 2009 Jun;10(2):75-80. doi: 10.1016/j.prrv.2009.02.004. Epub 2009 Apr 9. Review.

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil


title: Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis

acronym: ADEPT

summary:
Erosive hand osteoarthritis (EHOA) is a subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities.

Stimulation of the vagus nerve (VN), belonging to parasympathetic system, dampens pro-inflammatory cytokines production by splenic macrophages, through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages: this is the cholinergic anti-inflammatory pathway (CAP). Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). Beside implantable devices, VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN (tVNS) at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery.

The investigator do the hypothesis that auricular tVNS using a transcutaneous electrical nerve stimulation (TENS) device could be a novel, simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic EHOA.

location_facility: Rheumatology department Saint-Antoine Hospital


title: Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Adult Patients With Sickle-cell Disease Hospitalized for Acute Chest Syndrome. A Bi-centric, Open, Parallel-group, Randomized Controlled Study

summary:
Many patients with Sickle Cell Disease (SCD) may develop Acute Chest Syndrome (ACS). ACS is usually caused by a Lower respiratory tract infection (LRTI) which may be caused by either a bacterium or a virus. Antibiotics are usually used for 7 to 10 days with no microbiological workup.

The hypothesize of the study is that the identification of the microorganisms might lead to a reduction of antibiotics exposure and a better care of the patients.

We speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care

location_facility: Service de Réanimation et USC médico-chirurgicale


title: Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

acronym: PeSuLife

summary:
Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity.

The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons.

Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL).

The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)

ReferenceCitation: Fritel X, Varnoux N, Zins M, Breart G, Ringa V. Symptomatic pelvic organ prolapse at midlife, quality of life, and risk factors. Obstet Gynecol. 2009 Mar;113(3):609-616. doi: 10.1097/AOG.0b013e3181985312.

ReferenceCitation: Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. Review. French.

ReferenceCitation: Adjoussou SA, Bohoussou E, Bastide S, Letouzey V, Fatton B, de Tayrac R. [Functional symptoms and associations of women with genital prolapse]. Prog Urol. 2014 Jun;24(8):511-7. doi: 10.1016/j.purol.2013.11.015. Epub 2013 Dec 27. French.

ReferenceCitation: Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. Clinical Practice Guidelines: Synthesis of the guidelines for the surgical treatment of primary pelvic organ prolapse in women by the AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP. J Gynecol Obstet Hum Reprod. 2017 May;46(5):387-391. doi: 10.1016/j.jogoh.2017.05.001. Epub 2017 May 12.

ReferenceCitation: Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5. Review. Update in: Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014.

ReferenceCitation: Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O'Rourke P. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol. 2011 Apr;204(4):360.e1-7. doi: 10.1016/j.ajog.2010.11.016.

ReferenceCitation: Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizée D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.

ReferenceCitation: Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8.

ReferenceCitation: Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30.

ReferenceCitation: Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4. Review.

ReferenceCitation: Chevrot A, Droupy S, Linares E, de Tayrac R, Costa P, Wagner L. [Impact of laparoscopic sacrocolpopexy on symptoms, health-related quality of life and sexuality: A 3-year prospective study]. Prog Urol. 2016 Sep;26(10):558-65. doi: 10.1016/j.purol.2016.02.009. Epub 2016 Mar 24. French.

ReferenceCitation: Loffeld CJ, Thijs S, Mol BW, Bongers MY, Roovers JP. Laparoscopic sacrocolpopexy: a comparison of Prolene and Tutoplast mesh. Acta Obstet Gynecol Scand. 2009;88(7):826-30. doi: 10.1080/00016340902883158.

ReferenceCitation: Deprest J, De Ridder D, Roovers JP, Werbrouck E, Coremans G, Claerhout F. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol. 2009 Nov;182(5):2362-8. doi: 10.1016/j.juro.2009.07.043. Epub 2009 Sep 16.

ReferenceCitation: Govier FE, Kobashi KC, Kuznetsov DD, Comiter C, Jones P, Dakil SE, James R Jr. Complications of transvaginal silicone-coated polyester synthetic mesh sling. Urology. 2005 Oct;66(4):741-5.

ReferenceCitation: Sergent F, Resch B, Loisel C, Bisson V, Schaal JP, Marpeau L. Mid-term outcome of laparoscopic sacrocolpopexy with anterior and posterior polyester mesh for treatment of genito-urinary prolapse. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):217-22. doi: 10.1016/j.ejogrb.2011.01.022. Epub 2011 Feb 26.

ReferenceCitation: Antiphon P, Elard S, Benyoussef A, Fofana M, Yiou R, Gettman M, Hoznek A, Vordos D, Chopin DK, Abbou CC. Laparoscopic promontory sacral colpopexy: is the posterior, recto-vaginal, mesh mandatory? Eur Urol. 2004 May;45(5):655-61.

ReferenceCitation: D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23.

ReferenceCitation: Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95.

ReferenceCitation: Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30.

ReferenceCitation: Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.