title: Effects of an Intervention Among University Student to Promote Physical Activity and Reduce the Sedentary Time During COVID-19 Pandemic

summary:
Since the beginning of the COVID-19 pandemic, university students have faced many challenges and without any preparation. Studies conducted during the first lockdown show an increase in unhealthy lifestyles.

This study will be proposed to students from University of Nimes an 8-week physical activity program. Two groups will be constituted: the first will benefit from of innovative physical activity program on the base of the co-construction with users (Experimental Group), another that will not benefit from any intervention (Control Group). Investigators plan to include approximately 90 university students, 45 in each group.

The main goal of the study is to propose innovative program to promote PA (Physical Activity) and reduce ST (Sedentary Time) of young adults aged over 18 from university of Nîmes. The levels of PA and ST of the experimental group will be compared to a control group with the realization of pre and post intervention measures.

ReferenceCitation: Charbonnier E, Trémolière B, Baussard L, Goncalves A, Lespiau F, Philippe AG, Le Vigouroux S. Effects of an online self-help intervention on university students' mental health during COVID-19: A non-randomized controlled pilot study. Comput Hum Behav Rep. 2022 Mar;5:100175. doi: 10.1016/j.chbr.2022.100175. Epub 2022 Feb 10.

ReferenceCitation: Charbonnier, E., Le Vigouroux, S., & Goncalves, A. (2021). Etudiants en temps de confinement et au-delà. La Presse Médicale Formation. https://doi.org/10.1016/j.lpmfor.2021.06.011

ReferenceCitation: Ait-Aoudia M, Levy PP, Bui E, Insana S, de Fouchier C, Germain A, Jehel L. Validation of the French version of the Pittsburgh Sleep Quality Index Addendum for posttraumatic stress disorder. Eur J Psychotraumatol. 2013 Sep 12;4. doi: 10.3402/ejpt.v4i0.19298. eCollection 2013.

ReferenceCitation: Boiché J, Gourlan M, Trouilloud D, Sarrazin P. Development and validation of the 'Echelle de Motivation envers l'Activité Physique en contexte de Santé': A motivation scale towards health-oriented physical activity in French. J Health Psychol. 2019 Mar;24(3):386-396. doi: 10.1177/1359105316676626. Epub 2016 Nov 21.

ReferenceCitation: Lepine JP, Godchau M, Brun P. Anxiety and depression in inpatients. Lancet. 1985 Dec 21-28;2(8469-70):1425-6.

ReferenceCitation: Castro O, Bennie J, Vergeer I, Bosselut G, Biddle SJH. Correlates of sedentary behaviour in university students: A systematic review. Prev Med. 2018 Nov;116:194-202. doi: 10.1016/j.ypmed.2018.09.016. Epub 2018 Sep 25.

ReferenceCitation: Castro O, Bennie J, Vergeer I, Bosselut G, Biddle SJH. How Sedentary Are University Students? A Systematic Review and Meta-Analysis. Prev Sci. 2020 Apr;21(3):332-343. doi: 10.1007/s11121-020-01093-8.

ReferenceCitation: Deliens T, Van Crombruggen R, Verbruggen S, De Bourdeaudhuij I, Deforche B, Clarys P. Dietary interventions among university students: A systematic review. Appetite. 2016 Oct 1;105:14-26. doi: 10.1016/j.appet.2016.05.003. Epub 2016 May 13. Review.

ReferenceCitation: Gallè F, Sabella EA, Ferracuti S, De Giglio O, Caggiano G, Protano C, Valeriani F, Parisi EA, Valerio G, Liguori G, Montagna MT, Romano Spica V, Da Molin G, Orsi GB, Napoli C. Sedentary Behaviors and Physical Activity of Italian Undergraduate Students during Lockdown at the Time of CoViD-19 Pandemic. Int J Environ Res Public Health. 2020 Aug 25;17(17). pii: E6171. doi: 10.3390/ijerph17176171.

ReferenceCitation: Huckins JF, daSilva AW, Wang W, Hedlund E, Rogers C, Nepal SK, Wu J, Obuchi M, Murphy EI, Meyer ML, Wagner DD, Holtzheimer PE, Campbell AT. Mental Health and Behavior of College Students During the Early Phases of the COVID-19 Pandemic: Longitudinal Smartphone and Ecological Momentary Assessment Study. J Med Internet Res. 2020 Jun 17;22(6):e20185. doi: 10.2196/20185.

ReferenceCitation: Kertechian S, Swami V. An examination of the factor structure and sex invariance of a French translation of the Body Appreciation Scale-2 in university students. Body Image. 2017 Jun;21:26-29. doi: 10.1016/j.bodyim.2017.02.005. Epub 2017 Mar 6.

ReferenceCitation: Rodríguez-Larrad A, Mañas A, Labayen I, González-Gross M, Espin A, Aznar S, Serrano-Sánchez JA, Vera-Garcia FJ, González-Lamuño D, Ara I, Carrasco-Páez L, Castro-Piñero J, Gómez-Cabrera MC, Márquez S, Tur JA, Gusi N, Benito PJ, Moliner-Urdiales D, Ruiz JR, Ortega FB, Jiménez-Pavón D, Casajús JA, Irazusta J. Impact of COVID-19 Confinement on Physical Activity and Sedentary Behaviour in Spanish University Students: Role of Gender. Int J Environ Res Public Health. 2021 Jan 6;18(2). pii: E369. doi: 10.3390/ijerph18020369.

ReferenceCitation: Caron J. [A validation of the Social Provisions Scale: the SPS-10 items]. Sante Ment Que. 2013 Spring;38(1):297-318. French.

ReferenceCitation: Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. Review.

ReferenceCitation: Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25.

ReferenceType: result

ReferenceCitation: Le Vigouroux S, Goncalves A, Charbonnier E. The Psychological Vulnerability of French University Students to the COVID-19 Confinement. Health Educ Behav. 2021 Apr;48(2):123-131. doi: 10.1177/1090198120987128. Epub 2021 Jan 20.

ReferenceCitation: Goncalves A, Bernal C, Korchi K, Nogrette M, Deshayes M, Philippe AG, Gisclard B, Charbonnier E. Promoting Physical Activity Among University Students During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e36429. doi: 10.2196/36429.

lead_sponsor: University of Nimes


title: Study of the Association Between Tumor Microenvironment Macrophages and Treatment Response in Squamous Cell Carcinoma of the Anal Canal

acronym: MACARAN

summary:
Squamous cell carcinoma of the anal canal is a relatively rare cancer (less than 3% of digestive cancers) but its incidence has been increasing in recent decades, probably because of its association with HPV (human papillomavirus) infection. Its extension is mainly locoregional pelvic by lymphatic route, rarely metastatic. The standard treatment nowadays is radiotherapy combined with chemotherapy for locally advanced tumors (T2 or more corresponding to a size of 2 cm or more, or N+): mitomycin C and 5-FU (or capecitabine). While the 5-year disease control rates are excellent in localized forms, around 80%, for locally advanced tumors, the prognosis is poorer, with only 70% progression-free survival at 3 years in patients treated with radiochemotherapy. In these patients, it seems particularly interesting to understand the mechanisms of tumor resistance to treatments, in order to increase their efficacy and to propose new therapeutic targets.

The microenvironment of solid tumors, which has been extensively studied in the last two decades, is now recognized as a major factor in tumor development and invasion. Immune cells, and more particularly macrophages, represent an essential component of the tumor microenvironment, and constitute a link between innate and adaptive responses. The presence of tumor-associated macrophages (TAMs), and in particular M2 macrophages, with an anti-inflammatory and anti-tumor action (as opposed to M1 macrophages which are on the contrary tumoricidal and pro-inflammatory), has been studied in many cancers, such as head and neck squamous cell carcinoma, hepatocellular carcinoma, cervical squamous cell carcinoma, and non-small cell lung cancer. To investigator's knowledge, it has not been studied in squamous cell carcinoma of the anal canal.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Moureau-Zabotto L, Vendrely V, Abramowitz L, Borg C, Francois E, Goere D, Huguet F, Peiffert D, Siproudhis L, Ducreux M, Bouché O. Anal cancer: French Intergroup Clinical Practice Guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SNFCP). Dig Liver Dis. 2017 Aug;49(8):831-840. doi: 10.1016/j.dld.2017.05.011. Epub 2017 May 23. Review.

ReferenceCitation: Abramowitz L, Jacquard AC, Jaroud F, Haesebaert J, Siproudhis L, Pradat P, Aynaud O, Leocmach Y, Soubeyrand B, Dachez R, Riethmuller D, Mougin C, Pretet JL, Denis F. Human papillomavirus genotype distribution in anal cancer in France: the EDiTH V study. Int J Cancer. 2011 Jul 15;129(2):433-9. doi: 10.1002/ijc.25671. Epub 2010 Nov 9.

ReferenceCitation: James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. doi: 10.1016/S1470-2045(13)70086-X. Epub 2013 Apr 9.

ReferenceCitation: Evrard D, Szturz P, Tijeras-Raballand A, Astorgues-Xerri L, Abitbol C, Paradis V, Raymond E, Albert S, Barry B, Faivre S. Macrophages in the microenvironment of head and neck cancer: potential targets for cancer therapy. Oral Oncol. 2019 Jan;88:29-38. doi: 10.1016/j.oraloncology.2018.10.040. Epub 2018 Nov 20. Review.

ReferenceCitation: Cao L, Che X, Qiu X, Li Z, Yang B, Wang S, Hou K, Fan Y, Qu X, Liu Y. M2 macrophage infiltration into tumor islets leads to poor prognosis in non-small-cell lung cancer. Cancer Manag Res. 2019 Jul 4;11:6125-6138. doi: 10.2147/CMAR.S199832. eCollection 2019.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application

acronym: PhotodiVIN

summary: This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.

status: Recruiting

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Institut de Cancérologie de Lorraine

intervention_type: Drug

lead_sponsor_type: industriel


type: Other Identifier

title: Characterization of Adenosine A2A Receptor Expression and Fubnction in Hypercholesterolemic Patients

acronym: RASCAS

summary:
Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of LDL-cholesterol (LDL-C). Nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of CVD in hypercholesterolemic patients and develop better prevention and treatment strategies.

Adenosine via A2A receptors (A2AR) plays a crucial role in the regulation of the cardiovascular and immune systems.

In this project, the investigators wish :

To study whether the expression and function of A2AR in PBMCs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels.
To study whether A2AR expression and function in PBMCs are associated with blood levels of LDL-C and homocysteine and with the inflammatory status of patients.
To assess whether the cholesterol-lowering therapies currently used to reduce LDL-C levels and thus the risk of CVD in hypercholesterolemic patients have an impact on possible alterations of A2AR expression and function in PBMCs.

design_allocation: Non-Randomized

lead_sponsor: Assistance Publique Hopitaux De Marseille

intervention_type: Biological


title: TOcilizumab and Covid-19 : Risk of Severe INfection

acronym: TOCSIN

summary: SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18 months. The virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. The initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. A large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. Although Dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. The widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. A possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. Tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. The objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of Tocilizumab according to the severity of the patients.

ReferenceCitation: Birgand G, Peiffer-Smadja N, Fournier S, Kerneis S, Lescure FX, Lucet JC. Assessment of Air Contamination by SARS-CoV-2 in Hospital Settings. JAMA Netw Open. 2020 Dec 1;3(12):e2033232. doi: 10.1001/jamanetworkopen.2020.33232. Erratum in: JAMA Netw Open. 2021 Jan 4;4(1):e2037904.

ReferenceCitation: Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227.

ReferenceCitation: Leung NHL. Transmissibility and transmission of respiratory viruses. Nat Rev Microbiol. 2021 Aug;19(8):528-545. doi: 10.1038/s41579-021-00535-6. Epub 2021 Mar 22. Review.

ReferenceCitation: KENDALL EJ, BYNOE ML, TYRRELL DA. Virus isolations from common colds occurring in a residential school. Br Med J. 1962 Jul 14;2(5297):82-6.

ReferenceCitation: Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20. Review.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

ReferenceType: derived

ReferenceCitation: Sandhu G, Piraino ST, Piticaru J. Secondary Infection Risk in Patients With Severe COVID-19 Pneumonia Treated With Tocilizumab. Am J Ther. 2022 May-Jun 01;29(3):e275-e278. doi: 10.1097/MJT.0000000000001487. Epub 2022 Mar 4.


title: A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.

acronym: EPALEP

summary: A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

intervention_type: Procedure


title: Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

acronym: IRM Cardiaque

summary: The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.

primary_purpose: Other

lead_sponsor: Ramsay Générale de Santé


title: Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

acronym: EOLE

summary:
In patients with pulmonary embolism (PE), after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases.

The "RAMBO" trial is a French academic, multicenter, randomized (1:1 ratio), parallel arm, controlled, that aimed to assess the efficacy of pulmonary rehabilitation (PR) on the quality of life in patients with an acute symptomatic PE treated with anticoagulant therapy during at least 3 months and who present an impairment of quality of life and/or persistent dyspnea despite anticoagulant therapy.

Ventilation/Perfusion (V/Q) PET/CT is a novel imaging modality for the assessment of regional lung function. The same carrier molecules as conventional V/Q imaging are used, but they are labeled with 68Gallium, a ß+ isotope, instead of 99mTc, allowing acquisition of images with PET technology.

The EOLE study is an ancillary pilot study of the RAMBO trial, in which patients will benefit, in addition to the extensive work up scheduled as per study protocol, from a V/Q PET/CT scan before and after PR. The aim of the study is to assess the impact of PR on regional lung function with lung V/Q PET/CT imaging.

primary_purpose: Basic Science

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice

summary:
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.

All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.

time_perspective: Prospective

lead_sponsor: Biotech Dental

intervention_type: Device


title: Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

acronym: NSTBOS

summary:
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.

The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.

The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.

The investigators would like to study the non inferiority of this tool to choose the best plot .

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.

acronym: CROSS LEFT

summary: Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.

ReferenceCitation: Clementy N, Bodin A, Ah-Fat V, Babuty D, Bisson A. Dual-chamber ICD for left bundle branch area pacing: the cardiac resynchronization and arrhythmia sensing via the left bundle (cross-left) pilot study. J Interv Card Electrophysiol. 2022 Aug 16. doi: 10.1007/s10840-022-01342-6. [Epub ahead of print]

ipd_sharing: Undecided

ipd_sharing_description: IPD may be shared with manuscript reviewers, upon reasonable request.

lead_sponsor: University Hospital, Tours


title: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients

acronym: LURVIDOC

summary: To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

primary_purpose: Prevention

lead_sponsor: Poissy-Saint Germain Hospital


title: Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery

acronym: MIN-HYSTER

summary:
Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's recovery. Currently, minimally invasive surgical procedures combined with multimodal analgesia are commonly used to increase the quality of postoperative period.

Purpose To demonstrate that a minimally invasive approach including low insufflation pressure and minitrocars in laparoscopic hysterectomy improves postoperative recovery and reduces pain stimulation and opioid consumption in comparison with a conventional approach.

Methods After informed consent, all patients scheduled for a laparoscopic hysterectomy including those with carcinologic disease will be part of this monocentric prospective randomized double-blinded study.

At admission in our outpatient unit, patients will have to fill the Post-operative Quality of Recovery Scale assessment form, before to be randomized into one of the following two groups:

Conventional approach: laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation pressures between 10 and 12 mmHg.
Mini-invasive approach : laparoscopic surgery using mini-trocars (3 trocars of 3 mm and a 5 mm-optic trocar) with insufflation pressures of less than 8 mmHg.

Both groups will have general anesthesia with a deep neuromuscular blockade (TOF = 0 at the thumb adductor) and will benefit of our enhanced recovery program. Patients and evaluators will be blind regarding the allocated group.

The primary outcome is a comparison of the postoperative recovery between the two groups through the Post-operative Quality of Recovery Scale.This evaluation will include pain data, nausea/vomiting evaluation and cognitive function 6 hours after surgery.

Secondary outcomes are morphine consumption surgical comfort and patient satisfaction.

ReferenceCitation: Allam IS, Makled AK, Gomaa IA, El Bishry GM, Bayoumy HA, Ali DF. Total laparoscopic hysterectomy, vaginal hysterectomy and total abdominal hysterectomy using electrosurgical bipolar vessel sealing technique: a randomized controlled trial. Arch Gynecol Obstet. 2015 Jun;291(6):1341-5. doi: 10.1007/s00404-014-3571-3. Epub 2014 Dec 19.

ReferenceCitation: Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.

ReferenceCitation: Penn CA, Morgan DM, Rice LW, Harris JA, Rauh-Hain JA, Uppal S. Timing of and Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease. Obstet Gynecol. 2016 Oct;128(4):889-897. doi: 10.1097/AOG.0000000000001599.

ReferenceCitation: Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.

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

ReferenceCitation: Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1). pii: e2015.00113. doi: 10.4293/JSLS.2015.00113. Review.

ReferenceCitation: Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(®) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.

ReferenceCitation: Carvalho GL, Paquentin EM, Redan JA, Shadduck PP. The Science Behind Mini-Laparoscopic Cholecystectomy. Surg Technol Int. 2016 Oct 26;29:93-98. Review.

ReferenceCitation: Redan JA, Humphries AR, Farmer B, Paquentin EM, Koh CH, Chung MK, Stringel G, McCarus SD, Carvalho G, Diaz RG, Shadduck PP. "Big Operations Using Mini Instruments": The Evolution of Mini Laparoscopy in the Surgical Realm. Surg Technol Int. 2015 Nov;27:19-30.

ReferenceCitation: de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.

ReferenceCitation: Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.

ReferenceCitation: Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26. Review.

ReferenceCitation: Bonnet F, Marret E. Postoperative pain management and outcome after surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):99-107. Review.

ReferenceCitation: Wong M, Morris S, Wang K, Simpson K. Managing Postoperative Pain After Minimally Invasive Gynecologic Surgery in the Era of the Opioid Epidemic. J Minim Invasive Gynecol. 2018 Nov - Dec;25(7):1165-1178. doi: 10.1016/j.jmig.2017.09.016. Epub 2017 Sep 28. Review.

ReferenceCitation: Griffith KC, Clark NV, Zuckerman AL, Ferzandi TR, Wright KN. Opioid Prescription and Patient Use After Gynecologic Procedures: A Survey of Patients and Providers. J Minim Invasive Gynecol. 2018 May - Jun;25(4):684-688. doi: 10.1016/j.jmig.2017.11.005. Epub 2017 Nov 14.

ReferenceCitation: Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.

ReferenceCitation: Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review.

ReferenceCitation: Fuchs-Buder T, Meistelman C. [Monitoring of neuromuscular block and prevention of residual paralysis]. Ann Fr Anesth Reanim. 2009 Sep;28 Suppl 2:S46-50. doi: 10.1016/S0750-7658(09)72487-6. Review. French.

ReferenceCitation: Samimi S, Taheri A, Davari Tanha F. Comparison Between Intraperitoneal and Intravenous Lidocaine for Postoperative Analgesia After Elective Abdominal Hysterectomy, a Double-Blind Placebo Controlled Study. J Family Reprod Health. 2015 Nov;9(4):193-8.

ReferenceCitation: Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

ReferenceCitation: Le Gall L, David A, Carles P, Leuillet S, Chastel B, Fleureau C, Dewitte A, Ouattara A. Benefits of intraoperative analgesia guided by the Analgesia Nociception Index (ANI) in bariatric surgery: An unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):35-39. doi: 10.1016/j.accpm.2017.09.004. Epub 2017 Oct 12.

ReferenceCitation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

ReferenceCitation: Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6.

ReferenceCitation: Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, François G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23.

lead_sponsor: Institut Mutualiste Montsouris


title: Effects of Manipulating Swimming Speed and Frequency on Swimming Economy in High-level Swimmers and Para-swimmers

summary: The competitive swimming and open water swimming events are scheduled for the 2024 Paris Olympic and Paralympian Games. Generally associated with a non-neglectable number of medals in the last Olympics, swimming performance depends on the swimmer's ability to manage his or her Stroke Length and Stroke Rate, where Velocity can be defined as the product of SR and SL. The optimisation of this management depends on the swimmer's ability to develop a large motor repertoire and to use the coordination mode (catch-up, opposition, superposition) best suited to the environmental constraints and opponents' adversity. These adaptations may contribute to 1) a modification of the energy expenditure or be dependent on the energy supply necessary for muscular contraction and 2) the preferential use of one or other of the metabolic pathways in the production of this chemical energy, moreover in an aquatic environment inducing particular thermal exchanges.

status: Enrolling by invitation

ReferenceCitation: Thompson KG, Haljand R, MacLaren DP. An analysis of selected kinematic variables in national and elite male and female 100-m and 200-m breaststroke swimmers. J Sports Sci. 2000 Jun;18(6):421-31.

ReferenceCitation: Thompson KG, MacLaren DP, Lees A, Atkinson G. The effects of changing pace on metabolism and stroke characteristics during high-speed breaststroke swimming. J Sports Sci. 2004 Feb;22(2):149-57.

ReferenceCitation: Seifert L, Chollet D, Rouard A. Swimming constraints and arm coordination. Hum Mov Sci. 2007 Feb;26(1):68-86. Epub 2006 Nov 28.

ReferenceCitation: Seifert L, Komar J, Crettenand F, Millet G. Coordination pattern adaptability: energy cost of degenerate behaviors. PLoS One. 2014 Sep 25;9(9):e107839. doi: 10.1371/journal.pone.0107839. eCollection 2014.

ReferenceCitation: Seifert L, Komar J, Araújo D, Davids K. Neurobiological degeneracy: A key property for functional adaptations of perception and action to constraints. Neurosci Biobehav Rev. 2016 Oct;69:159-65. doi: 10.1016/j.neubiorev.2016.08.006. Epub 2016 Aug 6. Review.

ReferenceCitation: Ribeiro J, Toubekis AG, Figueiredo P, de Jesus K, Toussaint HM, Alves F, Vilas-Boas JP, Fernandes RJ. Biophysical Determinants of Front-Crawl Swimming at Moderate and Severe Intensities. Int J Sports Physiol Perform. 2017 Feb;12(2):241-246. doi: 10.1123/ijspp.2015-0766. Epub 2016 Aug 24.

lead_sponsor: University of Rouen Normandie

location_facility: Institut National du Sport, de l'Expertise et de la Performance

intervention_type: Other

status_simplified: Unknown


title: Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.

acronym: ERAV

summary: The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial Disease (OPAD) in critical ischemia, in the absence of usable great saphenous vein.

intervention_type: Behavioral


title: Evolution of Protective Immunization Against SARS-CoV-2 Among Hospital Workers in Health Care Facilities

acronym: ICONE

summary: To measure the immunization rate (seroneutralization) in a population of exposed hospital workers (nursing staff assigned to dedicated COVID-19 care units, laboratory staff handling COVID-19 samples).

primary_purpose: Screening

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Evaluation of the Effects of Bradykinin Antagonists on Pulmonary Manifestations of COVID-19 Infections (AntagoBrad-Cov Study).

acronym: AntagoBrad-Cov

summary: The main objective of this study is to evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (a specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.

status: Completed

study_completion_date_type: Actual

status_simplified: Completed


title: Registre HEAR, Healthcare European Amyloidosis Registry

summary:
This is a non-interventional, prospective, retrospective, non-comparative, multi-center study.

In order not to interfere with patient management, the study is observational. Thus, no follow-up visit is imposed. The data collection will be limited to the data related to the management of the patients included throughout their follow-up.

This study is intended for all patients with a confirmed or suspected diagnosis of cardiac amyloidosis. Three cohorts will be identified: the HEAR (Healthcare European Amyloidosis Registry)-Retrospective Cohort, the HEAR(Healthcare European Amyloidosis Registry)-Retrospective-Prospective Cohort and the HEAR (Healthcare European Amyloidosis Registry)-Prospective Cohort.

time_perspective: Other

lead_sponsor: Saving Lives Matters


title: Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

summary: The purpose of this study by automated control of oxygen supply in the immediate postoperative period is to show the possibility of immediate weaning in the postoperative period in case of remifentanil use and complete reversion of curarization.

lead_sponsor: Hopital Foch


title: Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

acronym: APMICI

summary: Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

ReferenceCitation: Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1. Review.

ReferenceCitation: Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1. Review.

ReferenceCitation: Gower-Rousseau C, Vasseur F, Fumery M, Savoye G, Salleron J, Dauchet L, Turck D, Cortot A, Peyrin-Biroulet L, Colombel JF. Epidemiology of inflammatory bowel diseases: new insights from a French population-based registry (EPIMAD). Dig Liver Dis. 2013 Feb;45(2):89-94. doi: 10.1016/j.dld.2012.09.005. Epub 2012 Oct 27.

lead_sponsor: Raincy Montfermeil Hospital Group


title: Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction

acronym: SCALA

summary:
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring

Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
Group 2: placebo: 0.5 ml in 1 injection


title: Validation in French of a Psychometric Tool for Measuring Health Literacy in the Field of Cancer

acronym: CaLiS

summary: Validation in French of a psychometric tool for measuring health literacy in the field of cancer

location_facility: Hôpital Privé des Peupliers, Ramsay Santé


title: DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls

acronym: DepLIPIDO

summary:
Depression is a disabling condition in terms of psychosocial alteration and also in terms of physical comorbidities. Depression doubles the risk of myocardial infarction compared with the general population, and this cardiovascular comorbidity leads to an increase in mortality in patients suffering from depression, even exceeding suicide-related mortality.

It is therefore important to better understand the mechanisms linking depression and cardiovascular disease.

Among the hypotheses that may account for the increased cardiovascular risk in patients with depression, lipid abnormalities are likely to play a crucial role.

Thus, qualitative and functional abnormalities in HDL lipoproteins are an important line of research, insofar as these lipid abnormalities have been recognized as important atherogenic abnormalities in populations at high cardiovascular risk, which is the case of patients with depression.

In this clinical, epidemiological and scientific context, a collaborative study undertaken by both the Department of Psychiatry of the Dijon Bourgogne University Hospital of and the INSERM LNC-UMR 1231 (PADYS) Laboratory of the UNIVERSITY OF BOURGOGNE FRANCHE-COMTE is an original translational research project, and the first study to perform a lipidomic analysis of HDL, coupled with a functional analysis of these lipoproteins in depression.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Interaction Between Air Pollution, Pollens and Allergic Rhinitis in the Aix-Marseille-Provence Metropolis

acronym: MISTRAL

summary:
Seasonal allergic rhinitis has multiple consequences: sleep disturbances, fatigue, depressed mood, impaired quality of life and productivity, and co-morbid conditions such as asthma, which affects one third of AR patients.

In Europe, more than 150 million people suffer from allergic rhinitis and more than 25 million suffer from asthma. About 30% have uncontrolled rhinitis during exposure to allergens. The impact of allergic diseases on work productivity is estimated to be between 30 and 50 billion € per year in the EU.

Studies show that pollution can play a role in the amplification of the response to inhaled pollen allergens by inducing morphological and functional modifications of nasal and bronchial epithelia, but also by inducing structural modifications of allergenic molecules. However, although data show that the symptoms of AR are aggravated by exposure to air pollution, this effect is not observed for all pollens.

The study area is very exposed to pollens (with a significant presence of cypress pollen) and air pollution, and presents a prevalence of asthma of 17% while the national average is about 7%.

The aim of this study is to establish, if they exist, links between pollens of various species, air pollution and symptoms of allergic rhinitis. The knowledge of these links will allow public authorities to set up prevention actions, and patients to better manage their allergic rhinitis on a daily basis.

lead_sponsor: MASK-air SAS


title: Study on High Potential in Adolescence School Boredom as a Precursor to a Depressive Episode Single-center, Comparative Study of High School Students

acronym: ESchAHP

summary:
The research focuses on "High Potential" (HP) in adolescence, in a link with the professional practice of the investigators.

Furthermore, supported by scientific literature and professional clinical practice, this research is interested in school boredom, regularly expressed by the consulting adolescents, in its relation with a depressive syndrome.

The objective of the research is to know if school boredom is a precursor of a depressive episode in high school students with HP compared to high school students without HP.

lead_sponsor: Centre Psychothérapique de Nancy

location_facility: Centre Psychothérapique de Nancy - CMP Adolescents Lunéville


title: Impact of Personalized Interventions to Raise Teleconsultation Awareness: The Case of the Cicat-Occitanie Network and Healthcare Professionals in Lozère's EHPADs

summary: The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss

acronym: ADIMOS-OB

summary:
Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant.

The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH…), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.

lead_sponsor: University Hospital, Lille


title: Comparative Study of the Personality Profile of Children and Adolescents With Attention Deficit Hyperactive Disorder (ADHD) With or Without Emotional Dysregulation

summary:
Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli.

According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood .

ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED.

The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories.

The second objectives are:

Improve understanding of the heterogeneity of ADHD symptom expression;
Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.


title: Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

acronym: ELECTROSTROKE

summary: The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.

ReferenceCitation: Mallouk N, Garcin A, Li G, Epinat M, Szczepaniak C, Hien OF, Mismetti P, Garnier P. Platelet transmission electron microscopy for the assessment of poor biological response to antiplatelet agent: pilot descriptive and prospective study - ELECTROSTROKE. BMJ Open. 2022 Apr 4;12(4):e050060. doi: 10.1136/bmjopen-2021-050060.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de St-Etienne


title: Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)

acronym: REACIMALLOGV

summary:
The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients.

The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Sugamamdex

summary:
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.

Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). The sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted.

Two questions have to be investigated. First, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? Second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.

lead_sponsor: Poitiers University Hospital


title: CArotid Robotic Procedure Evaluation

acronym: CARE

summary: This study aims to evaluate the use of R-One in the peripheral vasculature.

lead_sponsor: Robocath


title: Effect of Implementation of Enhanced Recovery After Surgery (ERAS) Protocol on 3-year Survival After Colorectal Surgery for Cancer - a Retrospective Cohort of 1001 Patients

acronym: RACCOR

summary: Several recent studies have shown that the Enhanced Recovery After Surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS). The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer.

ReferenceCitation: Alfonsi P, Slim K, Chauvin M, Mariani P, Faucheron JL, Fletcher D; le groupe de travail de la Societe francaise d'anesthesie et reanimation (Sfar) et de la Societe francaise de chirurgie digestive (SFCD). [Guidelines for enhanced recovery after elective colorectal surgery]. Ann Fr Anesth Reanim. 2014 May;33(5):370-84. doi: 10.1016/j.annfar.2014.03.007. Epub 2014 May 20. French.

ReferenceCitation: Gignoux B, Gosgnach M, Lanz T, Vulliez A, Blanchet MC, Frering V, Faucheron JL, Chasserant P. Short-term Outcomes of Ambulatory Colectomy for 157 Consecutive Patients. Ann Surg. 2019 Aug;270(2):317-321. doi: 10.1097/SLA.0000000000002800.

ReferenceCitation: Faucheron JL, Trilling B, Sage PY. Ambulatory colectomy: fast-track management pushed to its limits? Tech Coloproctol. 2018 Oct;22(10):741-742. doi: 10.1007/s10151-018-1871-5. Epub 2018 Nov 9. No abstract available.

ReferenceCitation: Trilling B, Sage PY, Faucheron JL. What is fast track multimodal management of colorectal cancer surgery in real life? Tech Coloproctol. 2018 May;22(5):401-402. doi: 10.1007/s10151-018-1799-9. Epub 2018 Jun 1. No abstract available.

ReferenceCitation: Carrier G, Cotte E, Beyer-Berjot L, Faucheron JL, Joris J, Slim K; Groupe Francophone de Réhabilitation Améliorée après Chirurgie (GRACE). Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery. J Visc Surg. 2016 Aug;153(4):249-52. doi: 10.1016/j.jviscsurg.2016.05.016. Epub 2016 Aug 8.

ReferenceCitation: Slim K, Delaunay L, Joris J, Léonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de réhabilitation améliorée après chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. Review.

ReferenceCitation: Faujour V, Slim K, Corond P. [The future, in France, of enhanced recovery after surgery seen from the economical perspective]. Presse Med. 2015 Jan;44(1):e23-31. doi: 10.1016/j.lpm.2014.07.021. Epub 2014 Dec 22. French.

ReferenceCitation: Launay-Savary MV, Mathonnet M, Theissen A, Ostermann S, Raynaud-Simon A, Slim K; GRACE (Groupe francophone de Rehabilitation Amelioree apres Chirurgie). Are enhanced recovery programs in colorectal surgery feasible and useful in the elderly? A systematic review of the literature. J Visc Surg. 2017 Feb;154(1):29-35. doi: 10.1016/j.jviscsurg.2016.09.016. Epub 2016 Nov 11.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19

acronym: CoviBlood

summary:
SARS-CoV-2 is responsible for COVID-19. Today, RT-PCR performed on a nasopharyngeal sample remains the gold standard for diagnosing SARS-CoV-2 infection. However, several other assays have been developed to increase testing capabilities and provide rapid screening strategies such as antigenic lateral flow assays. Most recommended tests to date are based nasopharyngeal sampling that is often poorly tolerated by patients and associated with a significant risk of infection for the sampler. Saliva can be used but provide slightly lower sensitivities depending of the subsequent assay use with those samples. The detection of the N antigen of SARS-CoV-2, by ELISA or rapid immunochromatographic technique, on a serum or blood sample would make it possible to overcome these constraints and to provide a new testing alternative. ELISA tests are faster, cheaper and easier to automate than molecular biology approaches.

Blood sampling may be easier to perform in certain populations (in particular in hospitalized patients who already benefit from blood sampling, blood donors, etc.), require less equipment, and is better tolerated (immunocompromised patients subject to blood sampling repeated), and can be integrated more systematically into assessments carried out at the entrance to hospitals or in town, etc. If the N-antigen levels in blood are sufficient, rapid antigen assay on capillary blood could also provide useful testing alternatives.

In a pilot study conducted at Bichat Claude Bernard Hospital, the sensitivity of the first available commercial test was estimated at 93% (95% CI, 84.7-100), and its specificity at 98% (95% CI, 85.3-100).

The main objective of the current work is to evaluate the sensitivity of the SARS-CoV-2 N antigen detection in the serum compared to nasopharyngeal SARS-CoV-2 PCR in several populations such as symptomatic hospitalized patients, symptomatic non-hospitalized patients and asymptomatic subjects.

For each detection kit evaluated, the primary endpoint is the sensitivity (and its 95% confidence interval) of the detection of SARS-CoV-2 N antigen in serum overall and in those populations. The specificity will also be assess.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Diagnostic Test


acronym: FLUDROSEPSIS

title: Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients

lead_sponsor: Rennes University Hospital

type: EudraCT Number

source: euctr

location_facility: Rennes University Hospital - Intensive Care unit

summary: The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.


title: Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo

acronym: Dexhia

summary: This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica

lead_sponsor: Nantes University Hospital


title: Restrictive Eating Disorders: From Childhood Orality Disorder to Adolescent Dysensoriality (Orality Dysensoriality and Eating Disorder)

acronym: ODYSSED

summary: This study offers to determine whether adolescent patients with a restrictive eating disorder have variations in their sensoriality compared to a control group.

ReferenceCitation: Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2.

ReferenceCitation: Gorwood P, Blanchet-Collet C, Chartrel N, Duclos J, Dechelotte P, Hanachi M, Fetissov S, Godart N, Melchior JC, Ramoz N, Rovere-Jovene C, Tolle V, Viltart O, Epelbaum J. New Insights in Anorexia Nervosa. Front Neurosci. 2016 Jun 29;10:256. doi: 10.3389/fnins.2016.00256. eCollection 2016.

ReferenceCitation: Schoen SA, Miller LJ, Green KE. Pilot study of the Sensory Over-Responsivity Scales: assessment and inventory. Am J Occup Ther. 2008 Jul-Aug;62(4):393-406. doi: 10.5014/ajot.62.4.393.

location_facility: Maison de Solenn Maison des Adolescents, Cochin Hospital


title: The Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff of the Hospital of Villeneuve Saint Georges and on Their Professional Activity. (SST-Covid Impact)

summary:
The aim of this research is to identify the consequences of the Covid-19 on the physical and psychological health of the nursing staff of the Intercommunal Hospital of Villeneuve-Saint-Georges and on their professional activity thanks to a self-questionnaire.

This anonymous self-questionnaire is intended for all the CHIV care workers who were infected by the coronavirus during the first wave and identified by the occupational health service.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges


title: Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.

acronym: ProprioRespi

summary: Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.

time_perspective: Cross-Sectional

lead_sponsor: Hakimi Adrien


title: Nurses-driven, Capnography-guided Protocol Weaning From the Mechanical Ventilation at Bedside: A Feasibility Study

acronym: NURSES-WEAN

summary:
Background: Prolonged mechanical ventilation (MV) exposes patients to increased risk of infection and mortality. A weaning protocol (WP) reduces the duration of MV. However, these protocols remain complicated to implement in clinical practice. These considerations led to the development of automated weaning systems (AWS) which are expensive and limited to expert centers.

Scope of the problem: AWS are not yet the standard care because evidence of AWS benefit is weak and several unanswered questions remain regarding their roles in weaning. There is a need for building new ways to improve WP. Indeed, medical staff's compliance with a daily screening of patients to wean is low. Moreover, modifications in ventilator settings require the availability of physicians at bedside and are rarely modified on a daily basis. This leads to impaired weaning process and prolonged MV for patients.

Acknowledge gap: Capnography (CAP) has been validated for intubation procedures and integrated into AWS. Some studies encouraging use of CAP have shown an optimization of MV, a decrease of unnecessary arterial blood gas without impacting patients' prognosis. However, the role of CAP in WP in intensive care units (ICU) has not been assessed so far.

Hypothesis: A nurse driven WP based on CAP may improve accuracy of weaning procedures at bedside. Such protocol might be easy to apply in daily practice and could reduce both the duration of MV and its related complications.

Methods: This is a prospective, bi-center, pilot study to assess the feasibility of a new nurses managed WP based on capnography among patients requiring more of 48 hours of MV. Enrollment of 100 consecutive patients in two ICU of the universitary hospital in Reims. The primary endpoint is the protocol compliance. Secondary endpoints are: capacity to performed a weaning (time to first extubation, total duration of MV...) caregivers' acceptance and feelings regarding the protocol, a safety evaluation with report of hospital mortality, ventilator associated-pneumonia, autoextubation, length of stay and the number of ABG/patient/day during the study period. Inclusion critera: all patients on MV for more than 48 hours and stabilization of the ICU entry pathology. Exclusion critera: Patients with severe neuropathy, cardiopathy or pulmonary disease. Weaning protocol begins when the following criteria are present: PEEP ≤ 8 cmH2O, PaO2/FiO2 ratio ≥150 (mmHg) or SaO2 ≥ 90% with FiO2 ≤ 0.5. The final criterion for study entry is successful completion of a 30-min spontaneous breathing test (SBT) using pressure support (PS) (max 30 cmH2O). After a successful test, nurse reduces PS by 2 mmHg every 3 hours and the FIO2 as long as the patient remains in his comfort zone defined as: FR 12-30/min, VT ≥ 6ml/kg and ETCO2 ≤ 55 mmHg (≤65 mmHg for chronic obstructive pulmonary disease (COPD) patients). A scale allows FIO2 and PEEP to be titrated with an oxygen saturation between 90% and 98% (92% for COPD). Nurses recorded every 3 hours ventilatory, hemodynamic, sedation parameters and modifications. At any time physicians can return to the previous settings if the patient is leaving the comfort zone. SBT are conducted when a minimum level of PS and PEEP is reached, 7cmH20 and 5cmH20 respectively. SBT performed using a T piece with or no oxygen for 30-120 min. If a patient passes a successful SBT and meets extubation criteria, he is extubed. Extubation and SBT protocols are performed according to French guidelines SFAR/SRLF. Nevertheless, extubation always remains the decision of the attending physician. Protocols continue until successful extubation (at least 48 hours of unassisted spontaneous breathing), ICU death, ICU discharge or until day 90 after randomization.

Interests and Scientific impacts: For patients, a potential reduction of VM duration and its associated-complications. For caregivers, a more efficient WP and a better optimization of workload. This pilot study will be a step before to investigate larger studies to compare our WP to standard care.

lead_sponsor: CHU de Reims


title: Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

acronym: DISE

summary: It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.

lead_sponsor: Elsan

location_facility: Centre du Sommeil de la Polyclinique de Poitiers


title: Feasibility Study of a Hypnosis Intervention and a Cognitive Behavioral Therapy Intervention to Reduce Fatigue in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

acronym: COLOFIGHT

summary:
In patients with colorectal cancer, fatigue ranks as the number one chemotherapy-related adverse event, with 75% of patients experiencing grade 3-4 physical and psychological consequences. Metastatic progression and increasing number of courses of chemotherapy are also aggravating factors.

In this study, the investigator will evaluate the feasibility of two standardized interventions aimed at reducing fatigue in patients with metastatic colorectal cancer. One of the two interventions will focus on hypnosis sessions while the other will implement Cognitive Behavioral Therapy (CBT) sessions.

primary_purpose: Supportive Care

ReferenceCitation: Stone P, Richardson A, Ream E, Smith AG, Kerr DJ, Kearney N. Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum. Ann Oncol. 2000 Aug;11(8):971-5. doi: 10.1023/a:1008318932641.

ReferenceCitation: Forlenza MJ, Hall P, Lichtenstein P, Evengard B, Sullivan PF. Epidemiology of cancer-related fatigue in the Swedish twin registry. Cancer. 2005 Nov 1;104(9):2022-31. doi: 10.1002/cncr.21373.

ReferenceCitation: Lawrence DP, Kupelnick B, Miller K, Devine D, Lau J. Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr. 2004;(32):40-50. doi: 10.1093/jncimonographs/lgh027.

ReferenceCitation: Kangas M, Bovbjerg DH, Montgomery GH. Cancer-related fatigue: a systematic and meta-analytic review of non-pharmacological therapies for cancer patients. Psychol Bull. 2008 Sep;134(5):700-741. doi: 10.1037/a0012825. Erratum In: Psychol Bull. 2009 Jan;135(1):172.

ReferenceCitation: Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914.

ReferenceCitation: Berger AM, Kuhn BR, Farr LA, Lynch JC, Agrawal S, Chamberlain J, Von Essen SG. Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psychooncology. 2009 Jun;18(6):634-46. doi: 10.1002/pon.1438.

ReferenceCitation: Cousson-Gelie F, Bruchon-Schweitzer M, Atzeni T, Houede N. Evaluation of a psychosocial intervention on social support, perceived control, coping strategies, emotional distress, and quality of life of breast cancer patients. Psychol Rep. 2011 Jun;108(3):923-42. doi: 10.2466/02.07.15.20.PR0.108.3.923-942.

ReferenceCitation: Page MS, Berger AM, Johnson LB. Putting evidence into practice: evidence-based interventions for sleep-wake disturbances. Clin J Oncol Nurs. 2006 Dec;10(6):753-67. doi: 10.1188/06.CJON.753-767.

ReferenceCitation: Morin CM, Vallières A, Guay B, Ivers H, Savard J, Mérette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.

ReferenceCitation: Carlson LE, Zelinski E, Toivonen K, Flynn M, Qureshi M, Piedalue KA, Grant R. Mind-Body Therapies in Cancer: What Is the Latest Evidence? Curr Oncol Rep. 2017 Aug 18;19(10):67. doi: 10.1007/s11912-017-0626-1. Review.

ReferenceCitation: Barsevick AM, Irwin MR, Hinds P, Miller A, Berger A, Jacobsen P, Ancoli-Israel S, Reeve BB, Mustian K, O'Mara A, Lai JS, Fisch M, Cella D; National Cancer Institute Clinical Trials Planning Meeting. Recommendations for high-priority research on cancer-related fatigue in children and adults. J Natl Cancer Inst. 2013 Oct 2;105(19):1432-40. doi: 10.1093/jnci/djt242. Epub 2013 Sep 18.

ReferenceCitation: Sood A, Barton DL, Bauer BA, Loprinzi CL. A critical review of complementary therapies for cancer-related fatigue. Integr Cancer Ther. 2007 Mar;6(1):8-13. doi: 10.1177/1534735406298143.

ReferenceCitation: Cramer H, Lauche R, Paul A, Langhorst J, Kummel S, Dobos GJ. Hypnosis in breast cancer care: a systematic review of randomized controlled trials. Integr Cancer Ther. 2015 Jan;14(1):5-15. doi: 10.1177/1534735414550035. Epub 2014 Sep 18.

ReferenceCitation: Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. Epub 2007 Aug 28.

ReferenceCitation: Montgomery GH, Sucala M, Baum T, Schnur JB. Hypnosis for Symptom Control in Cancer Patients at the End-of-Life: A Systematic Review. Int J Clin Exp Hypn. 2017 Jul-Sep;65(3):296-307. doi: 10.1080/00207144.2017.1314728. Review.

ReferenceCitation: Jensen MP, Gralow JR, Braden A, Gertz KJ, Fann JR, Syrjala KL. Hypnosis for symptom management in women with breast cancer: a pilot study. Int J Clin Exp Hypn. 2012;60(2):135-59. doi: 10.1080/00207144.2012.648057.

ReferenceCitation: Gentile S, Delaroziere JC, Favre F, Sambuc R, San Marco JL. Validation of the French 'multidimensional fatigue inventory' (MFI 20). Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64. doi: 10.1046/j.1365-2354.2003.00295.x.

ReferenceCitation: Hinz A, Fleischer M, Brahler E, Wirtz H, Bosse-Henck A. Fatigue in patients with sarcoidosis, compared with the general population. Gen Hosp Psychiatry. 2011 Sep-Oct;33(5):462-8. doi: 10.1016/j.genhosppsych.2011.05.009. Epub 2011 Jun 24.

ReferenceCitation: Kuhnt S, Ernst J, Singer S, Ruffer JU, Kortmann RD, Stolzenburg JU, Schwarz R. Fatigue in cancer survivors--prevalence and correlates. Onkologie. 2009 Jun;32(6):312-7. doi: 10.1159/000215943. Epub 2009 May 12.

ReferenceCitation: Singer S, Kuhnt S, Zwerenz R, Eckert K, Hofmeister D, Dietz A, Giesinger J, Hauss J, Papsdorf K, Briest S, Brown A. Age- and sex-standardised prevalence rates of fatigue in a large hospital-based sample of cancer patients. Br J Cancer. 2011 Jul 26;105(3):445-51. doi: 10.1038/bjc.2011.251. Epub 2011 Jul 12.

ReferenceCitation: Askay SW, Patterson DR, Sharar SR. VIRTUAL REALITY HYPNOSIS. Contemp Hypn. 2009 Mar;26(1):40-47.

ReferenceCitation: Montgomery GH, David D, Winkel G, Silverstein JH, Bovbjerg DH. The effectiveness of adjunctive hypnosis with surgical patients: a meta-analysis. Anesth Analg. 2002 Jun;94(6):1639-45, table of contents.

ReferenceCitation: Schnur JB, Kafer I, Marcus C, Montgomery GH. HYPNOSIS TO MANAGE DISTRESS RELATED TO MEDICAL PROCEDURES: A META-ANALYSIS. Contemp Hypn. 2008 Aug 21;25(3-4):114-128. doi: 10.1002/ch.364.

ReferenceCitation: Montgomery GH, Schnur JB, Kravits K. Hypnosis for cancer care: over 200 years young. CA Cancer J Clin. 2013 Jan;63(1):31-44. doi: 10.3322/caac.21165. Epub 2012 Nov 20. Review.

ReferenceCitation: Gielissen MF, Verhagen S, Witjes F, Bleijenberg G. Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. J Clin Oncol. 2006 Oct 20;24(30):4882-7.

ReferenceCitation: Gielissen MF, Verhagen CA, Bleijenberg G. Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up. Br J Cancer. 2007 Sep 3;97(5):612-8. Epub 2007 Jul 24.

ReferenceCitation: Poort H, Verhagen CA, Peters ME, Goedendorp MM, Donders AR, Hopman MT, Nijhuis-van der Sanden MW, Berends T, Bleijenberg G, Knoop H. Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer. BMC Cancer. 2017 Jan 28;17(1):81. doi: 10.1186/s12885-017-3076-0.

ReferenceCitation: Baussard L, Cousson-Gélie F, Jarlier M, Charbonnier E, Le Vigouroux S, Montalescot L, Janiszewski C, Fourchon M, Coutant L, Guerdoux E, Portales F. Hypnosis and cognitive behavioral therapy with online sessions to reduce fatigue in patients undergoing chemotherapy for a metastatic colorectal cancer: Rational and study protocol for a feasibility study. Front Psychol. 2022 Jul 27;13:953711. doi: 10.3389/fpsyg.2022.953711. eCollection 2022.

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

location_facility: Institut régional du Cancer de Montpellier


title: A Prospective, Triple Blinded, Randomized, Controlled Clinical Study of the Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds

acronym: MLIDOM

summary:
This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products.

Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.

lead_sponsor: Laboratoires Vivacy


title: Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

summary:
For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance.

Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit.

While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities.

On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied.

The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail.

The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

lead_sponsor: Institut de Formation et de Recherche en Médecine de Montagne


title: Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis

acronym: IMMUNOIMAGING

summary: It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: assistance publique hôpitaux de Marseille


title: History of Exposure to Endocrine Disruptors in Women With Polycystic Ovary Syndrome

summary:
Polycystic ovary syndrome is a common endocrine disorder that affects between 7% and 14% of women of childbearing age, leading to impaired fertility, clinical and biological hyperandrogenism.

Long-term complications such as metabolic disorders, cardiovascular disease and hormone-dependent cancers make it a major public health problem.

The physiopathology of this syndrome is complicated and still poorly understood, probably multifactorial origin, resulting from the interaction between many factors (genetics, lifestyle, environment).

The environment has also an important role in the development of polycystic ovary syndrome : diet, exposure to pollutants and endocrine disruptors.

There are many sources of exposure to environmental toxins and it is essential to better understand their impact on our health.

Our study aims to assess the association between exposure to endocrine disruptors and development of polycystic ovary syndrome.

The population involved in the study includes patients aged 18 to 50 years, premenopausal, consulting in the gynecology department of the university hospital of Reims.

The "cases" patients will be patients with polycystic ovary syndrome. The "controls" patients will be patients without polycystic ovary syndrome. Statistical analysis will determine whether "cases" are more exposed to endocrine disruptors than "controls".


acronym: HCQMa

title: Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients: Proof of Concept Study

lead_sponsor: University Hospital, Toulouse

ReferenceCitation: Fradet M, Negretto M, Tournier E, Laurent C, Apoil PA, Evrard S, Degboe Y, Del Mas V, Lamant L, Dubreuil P, Laroche M, Mailhol C, Hermine O, Paul C, Bulai Livideanu C. Frequency of isolated cutaneous involvement in adult mastocytosis: a cohort study. J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1713-1718. doi: 10.1111/jdv.15638. Epub 2019 May 17.

ReferenceCitation: Severino M, Chandesris MO, Barete S, Tournier E, Sans B, Laurent C, Apoil PA, Lamant L, Mailhol C, Laroche M, Fraitag S, Hanssens K, Dubreuil P, Hermine O, Paul C, Bulai Livideanu C. Telangiectasia macularis eruptiva perstans (TMEP): A form of cutaneous mastocytosis with potential systemic involvement. J Am Acad Dermatol. 2016 May;74(5):885-91.e1. doi: 10.1016/j.jaad.2015.10.050. Epub 2016 Feb 19.

location_facility: Larrey Hospital - Toulouse University Hospital

summary:
The treatment of systemic mastocytosis has two main axes:

Control of mast cell activation symptoms and
The control of proliferation (accumulation) of mast cells.

There is no standard treatment and no treatment has a marketing authorization for the treatment of monoclonal indolent mastocytosis.


title: Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability

summary: The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.

lead_sponsor: Ramsay Générale de Santé


acronym: FAMODREP

title: Interest of Famotidine in Reducing Endothelial Expression of P-selectin in Children With Sickle Cell Disease: Pilot Study, Single-center, Prospective, Non-comparative.

location_facility: Necker - Enfants malades Hospital; Department of Pediatrics and Infectious Diseases

summary:
The purpose of this study is to determine whether oral famotidine, a histamine type 2 receptor antagonist already widely used with very few side effects in other indications in children, is effective in reducing endothelial expression of P-selectin in children with sickle cell disease (SCD).

This pilot study will constitute the essential prerequisite for a randomized clinical trial comparing the efficacy of famotidine with that of placebo in the prevention of vaso-occlusive crises in SCD patients.


title: Robot-assisted and Connected 6-minute Walk Test (TM6)

summary: Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche


title: Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal

acronym: STIM-ALC

summary: High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Effect of a Mixture of Probiotics (Lactibiane Reference) in Patients With Irritable Bowel Syndrome Predominantly Constipation and Assessment of a Potential Biomarker (Resolvin D1): an Exploratory Study

acronym: EPORE

summary: Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

lead_sponsor: CEN Biotech

intervention_type: Dietary Supplement


title: Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

acronym: RAMSES

summary:
Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc.

An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics.

Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.


title: Role of Innate T Cells in Physiopathology of Systemic Sclerosis

summary:
Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy.

Data are however scarce and physiopathological mechanisms have not been assessed to date.

The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.

lead_sponsor: Poitiers University Hospital


title: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique

acronym: ETRE

summary:
Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.

The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.

lead_sponsor: Institut Curie


title: Impact of Iron Deficiency on the Incidence of Postoperative Infections - CARIPO Observational Study

acronym: CARIPO

summary: Iron deficiency is a common state during the perioperative period. Data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. This prospective observational study aims to assessed the postoperative infections incidence according to the preoperative iron-stock status.

lead_sponsor: University Hospital, Angers


title: Acceptability, Representations and Experiences of the COVID-19 Pandemic : the ARECOVID Project

acronym: ARECOVID

summary: The "ARECOVID" project is a comprehensive sociological study of what is being played out in organizational terms in the face of the COVID-19 pandemic. Through quantitative methods (questionnaires) and qualitative methods (semi-directive interviews), we would understand the essential views of the populations concerned by COVID-19, but also that of actors taking care of vulnerable elderly non-COVID. Special attention will be paid to the care pathway of elderly people with and without the virus, in a health system in full reorganization. We will try to understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home, in order to reflect on a possible improvement in the health response of elderly people in the event of an epidemic health crisis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Observational Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma

acronym: TCL

summary:
Head injuries are a common reason for consultation in emergency departments. The clinical severity of head injury is assessed using the Glasgow Coma Scale (GCS). Between 71% and 97.5% of patients with head trauma seen in the emergency department are considered minor, that is to say with an initial GCS 13 and the consequences are quite variable. Three to 10% of patients will have short, medium or long-term health consequences. According to the studies, there are between 2.1 and 8% of intracranial bleeding immediate or delayed (up to one month), with about 1% of them, the need to resort to neurosurgery.

Following a minor head trauma, it is recommended, in the absence of clinical signs of severity, to realize a brain scan (cerebral computerized tomography scan (CT scan): reference imaging examination) within 6h (between 4 hours and 8 hours according to studies), a hospital surveillance of 24h, with the realization of a control scanner within 12 hours to 24 hours in case of treatment by anticoagulants or antiaggregation.

In December 2015, Journal of the American Medical Association published an article evaluating two clinical algorithms across the Atlantic, the New Orleans Criteria (NOC) and the Canadian CT Head Rule, to identify a group of patients with a very low risk of severe brain damage.

The performance of this score is unquestionably, however, it does not include patients treated with antiplatelet or anticoagulant drugs; risk factors having a decisive impact on the incidence of intracranial bleeding.

In this context, various studies have been carried out retrospectively in Angers to assess the incidence and risk factors of the occurrence of an immediate or delayed intracerebral hemorrhage in patients with minor head trauma with or without anti-thrombotic treatment.


title: Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age

acronym: TFNA

summary:
Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were > 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest


title: Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital

acronym: EIPSL

summary:
Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.

In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP Pitié-Salpêtrière Hospital, Department of Cardiology


title: Oral Health and Pregnancy : Relation Between Knowledge, Practices and Social Representation of Pregnant Women in the Gynecologie Department at the Montpellier's CHRU

acronym: OHAP

summary: The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.

lead_sponsor: University Hospital, Montpellier


title: Detection, Evaluation and Monitoring of Frailties in the Elderly

acronym: FRAGING

summary:
The aging of the French population is a major public health issue. Frailty is a reversible clinical state between optimal healthy aging and pathological aging. Early detection of frailty makes it possible to identify people aged 65 or over who are at risk of developing or worsen dependency and to offer them appropriate medical and/or social care adapted to their needs. The multidimensional screening program known as "ICOPE" (for "Integrated Care of Older People") promoted by the World Health Organization (WHO) aims to prevent functional decline worldwide and improve the well-being of older people. To support healthy aging, 6 intrinsic abilities are to be screened according to ICOPE: visual impairment, hearing impairment, depressive symptoms, locomotor abilities, cognitive decline and vitality. This program is intended to be developed in each country and adapted to the territories of action. The Mauriac and Vichy community health basins have a proportion of elderly people (≥60 years old) that is much higher than regional and national data, justifying the regional and national data, justifying the chosen action territories. The epidemiological characteristics of the French population and of the action territory made it possible to add to the following themes to the ICOPE recommendations: socio-economic situation, assistance to caregivers, vaccinations, drug iatrogeny, alcohol consumption, cardiovascular risk and cancer screening. The ICOPE process is organized in 5 steps: a community screening and a relay to the general practitioner to ensure a follow-up, an primary care in case of abnormality, evaluated at 3 months and then 6 months, establishment of a plan of care if necessary, possible referral to a specialist and mobilization of community resources mobilization of community resources and support for caregivers if needed.

The hypothesis is that conducting a fragility screening in a rural area (Mauriac health (Mauriac health basin) and a semi-urban area (Vichy health basin) would allow an effective would allow an effective allocation of expenses. In more detail, the costs are direct medical, direct non-medical, indirect and intangible costs, and efficiency is measured by measured by the quality of life score (LEIPAD). The hypothesis is that the early detection of people's frailties and their management improves their quality of life

lead_sponsor: University Hospital, Clermont-Ferrand


title: Unplanned-extubation in the Intensive Care Unit; Incidence, Characteristics and Prognosis.

acronym: SAFE-ICU

summary: Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with "success" or "failure" in the self-extubation subgroup.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation


title: A Prospective Pilot Study to Assess the Efficacy of Botox-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection

acronym: BOTOX-TME

summary: After rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.

lead_sponsor: University Hospital, Bordeaux


title: Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.

acronym: BEVAR

summary: Aneurysm of the abdominal aorta is defined by a loss of parallelism of the arterial wall. The main risk of this pathology is the rupture of the aneurysm which is life threatening and this risk increases with the size of the aneurysm. Connected stents allow the management of complex thoracoabdominal aneurysms in patients at high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term CT follow-up remains essential to detect complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The prognostic factors of these complications remain poorly elucidated. The type of stent to be used could be an explanation, however, no stent has been proven to be superior in this application to date. Data from the literature suggest an influence of stents on the aortic geometry and the arterial axes of the digestive tract during respiratory movements. The work of the Stanford vascular surgery team shows that the deformations and modifications of the geometry of these stents induced by the respiratory cycle could have a negative impact by migration, stenosis and thrombosis.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.

summary: The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.


title: Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

acronym: SPYSI

summary:
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.

The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.


title: A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC

acronym: PEREM

summary:
Descriptive: A 24-month multicentre, observational, prospective cohort study. Population: IBD Patients under stable clinical and biological remission Study treatments: Patients who will be proposed to switch, or who have just switched, from the intravenous originator Remicade® or one of its biosimilars to the subcutaneous infliximab Remsima®SC as part of routine care. All consecutive patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.

Objectives:The primary objective of PEREM study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from IV infliximab to subcutaneous infliximab Remsima®SC.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives