title: Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism

acronym: PARA-REIN

summary: Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.


title: Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System

summary:
Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and HR using the absorption of light by the blood to define these signals In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal.

Although these systems have been technically valid, they have not been clinically evaluated in a health setting. This clinical trial is to assess parameters measurements by rPPG compared standard acquisition system in real conditions

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Allado E, Poussel M, Moussu A, Saunier V, Bernard Y, Albuisson E, Chenuel B. Innovative measurement of routine physiological variables (heart rate, respiratory rate and oxygen saturation) using a remote photoplethysmography imaging system: a prospective comparative trial protocol. BMJ Open. 2021 Aug 13;11(8):e047896. doi: 10.1136/bmjopen-2020-047896.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centre Hospitalier Régional Universitaire de Nancy.

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.

summary: Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

study_type: Observational

time_perspective: Retrospective

location_facility: Centre Hospitalier Régional Universitaire

intervention_type: Procedure


title: Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays

summary:
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
Allow to obtain an estimation of number of patients required for a larger study.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

status_simplified: Completed


title: Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive

acronym: Odorat-Covid

summary:
One of the most common causes of loss of smell is upper respiratory tract infection. These disorders can be quantitative (hyposmia or anosmia) or qualitative (parosmia or phantosmia). Loss of smell has been found as a major and frequent clinical sign of Sars Cov2 infection (more than 50% of patients screened at the CHU Nancy). Spontaneous recovery remains possible. It usually occurs in the first month . But when symptoms persist, the therapeutic management of post-viral anosmias is poorly codified in the literature. Olfactory rehabilitation could allow faster recovery and better quality, but the published protocols are numerous and could only be tested on small inhomogeneous series of patients (mixture of post-viral and post-traumatic hypo-ansomy). The significant increase in the population of patients suffering from post-viral anosmia following the current pandemic situation makes it possible to consider a prospective study aiming to compare two olfactory rehabilitation protocols: "classic" and "intensive" in a population of patients. suffering only from post-viral hypoanosmia.

Hypothesis: Intensive or classic olfactory rehabilitation allows better results than spontaneous recovery

design_allocation: Randomized

primary_purpose: Other

intervention_type: Other


title: Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?

summary: In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

ipd_sharing: Undecided


title: Contribution of [18F] -FDG-PET / MRI in the Detection of the Absence of Complete Response After Neo-adjuvant Radiotherapy for Cancers of the Middle and Low Rectum for a Treatment Procedure With Rectal Savings

acronym: RECARHIA

summary:
Rectal cancer represents 14,000 new cases a year in France. At diagnosis, 70% of patients have a locally advanced tumors T3-T4 and / or N + evaluated mainly by rectal MRI. These patients will benefit from a neo-adjuvant treatment by radio-chemotherapy. The complete histologic response rate (ypT0N0) after this neo-adjuvant treatment ranged from 15 to 27% and improved recurrence-free survival, remotely relapse-free survival, overall survival, and decreased local recurrence rate. In the case of full response diagnosis after neoadjuvant chemoradiotherapy 3 theoretical solutions exist:

Total excision of the rectum and mesorectum (TME) This is the classic attitude with a low risk of local recurrence (5%) but functional complications occur in 25 to 60% of cases
A simple monitoring ("Watch and Wait") by MRI, biopsy, rectoscopy ... This strategy was initially proposed to elderly patients considered inoperable but it has also been proposed in younger patients, operable, with a view to decreasing morbidity and sequelae. This attitude poses a likely overall risk of local recidivism. However, this higher risk of recurrence may be the result of imperfect identification of ypT0N0 patients.
Local excision of the post-radiation scar also called closure lumpectomy with pathological analysis and possible secondary TME if no complete response. This last attitude has the advantage of allowing an anatomopathological verification of the treated lesion and to complete the treatment if necessary. In the case of ypT0 the local recurrence rate is low and in this case it is possible to consider rectal savings.

The choice of the last two attitudes is therefore based on the correct identification of patients in complete response. The performance of the diagnosis of no complete response after radiochemotherapy is therefore fundamental and is the subject of this project wich consist of comparing he diagnostic performance for the identification of a complete lack of response [18F] -FDG-PET / MRI ypT0N0 to that of the classic attitude (MRI) 6 to 9 weeks after the end of a neoadjuvant chemoradiotherapy treatment of low and mid-rectal cancers in patients in whom clinical and endoscopic examination favor a complete response.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Radiation

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: RECARHIA

titre: Apport de la [18F]-FDG-TEP/IRM dans la détection de l'absence de  réponse complète après radiochiomiothérapie néo-adjuvante pour les cancers du moyen et du bas rectum en vue d'une procédure de traitement avec épargne rectale

discipline_principale: autre

nom_porteur: LUCIDARME

prenom_porteur: Olivier


title: From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

acronym: MODAP

summary: The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" [3]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research [4]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Gross-Goupil M, Escudier B. [Targeted therapies: sequential and combined treatments]. Bull Cancer. 2010;97:65-71. doi: 10.1684/bdc.2010.1071. French.

ReferenceCitation: Hoarau H, Giacomoni C, Etienne G, Fort MP, Mahon FX, Ceccaldi J, Reiffers J, Monnereau A. Expérience quotidienne des patients atteints de LMC traités par voie orale : déterminants des pratiques d'observance ?. Oncologie, 2012, n° 14, p. 609-612.

ReferenceCitation: Santucci R, Aatmani AE, Lescoute A, Leveque D, Serra S, Bergerat JP, Beretz L, Herbrecht R. [Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Bull Cancer. 2011 Feb;98(2):176-81. doi: 10.1684/bdc.2011.1308. French.

ReferenceCitation: Regnier Denois V, Poirson J, Nourissat A, Jacquin JP, Guastalla JP, Chauvin F. Adherence with oral chemotherapy: results from a qualitative study of the behaviour and representations of patients and oncologists. Eur J Cancer Care (Engl). 2011 Jul;20(4):520-7. doi: 10.1111/j.1365-2354.2010.01212.x. Epub 2010 Jul 23.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection

acronym: RIPI

summary: As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy

acronym: DyGenEpi

summary: Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy


title: Assessing the Performance of Shotgun Metagenomics in the Diagnosis of Complex Prosthetic Joint Infections (METAGENOS)

acronym: METAGENOS

summary:
The objectiveof this of a prospective, multicentre study is to evaluate the performance of shotgun metagenomics in the diagnosis of chronic Prosthetic joint infection (PJI) in comparison with the adapted MSIS diagnostic score..

The main questions it aims to answer are:

To evaluate the performance of shotgun metagenomics in the diagnosis of chronic PJI in comparison with culture.
To describe the epidemiology of bacterial species responsible for chronic PJI in Western France and their potential resistance to antibiotics.
Analyzing the diagnostic performance of shotgun culture and metagenomics as a function of potentially administered antibiotic treatments A total of 143 patients sampled will be included. Six intraoperative samples will be taken for each patient, as part of routine care. In addition to the standard preoperative check-up, an extra volume of blood will be taken for CRP measurement at inclusion.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

status_simplified: Ongoing


title: Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study

summary:
Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity.

One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP).

However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital..

Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs,

The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications.

The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy.

The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.

ReferenceCitation: Ho V, Heslin MJ. Effect of hospital volume and experience on in-hospital mortality for pancreaticoduodenectomy. Ann Surg. 2003 Apr;237(4):509-14. doi: 10.1097/01.SLA.0000059981.13160.97.

ReferenceCitation: DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9. doi: 10.1097/01.sla.0000246856.03918.9a.

ReferenceCitation: Okano K, Hirao T, Unno M, Fujii T, Yoshitomi H, Suzuki S, Satoi S, Takahashi S, Kainuma O, Suzuki Y. Postoperative infectious complications after pancreatic resection. Br J Surg. 2015 Nov;102(12):1551-60. doi: 10.1002/bjs.9919. Epub 2015 Sep 21.

ReferenceCitation: Yu L, Huang Q, Xie F, Lin X, Liu C. Risk factors of postoperative complications of pancreatoduodenectomy. Hepatogastroenterology. 2014 Oct;61(135):2091-5.

ReferenceCitation: Lermite E, Pessaux P, Teyssedou C, Etienne S, Brehant O, Arnaud JP. Effect of preoperative endoscopic biliary drainage on infectious morbidity after pancreatoduodenectomy: a case-control study. Am J Surg. 2008 Apr;195(4):442-6. doi: 10.1016/j.amjsurg.2007.03.016.

ReferenceCitation: Scheufele F, Aichinger L, Jager C, Demir IE, Schorn S, Sargut M, Erkan M, Kleeff J, Friess H, Ceyhan GO. Effect of preoperative biliary drainage on bacterial flora in bile of patients with periampullary cancer. Br J Surg. 2017 Jan;104(2):e182-e188. doi: 10.1002/bjs.10450.

ReferenceCitation: Cortes A, Sauvanet A, Bert F, Janny S, Sockeel P, Kianmanesh R, Ponsot P, Ruszniewski P, Belghiti J. Effect of bile contamination on immediate outcomes after pancreaticoduodenectomy for tumor. J Am Coll Surg. 2006 Jan;202(1):93-9. doi: 10.1016/j.jamcollsurg.2005.09.006. Epub 2005 Nov 18.

ReferenceCitation: Kruger CM, Adam U, Adam T, Kramer A, Heidecke CD, Makowiec F, Riediger H. Bacterobilia in pancreatic surgery-conclusions for perioperative antibiotic prophylaxis. World J Gastroenterol. 2019 Nov 7;25(41):6238-6247. doi: 10.3748/wjg.v25.i41.6238.


title: Demographic Characteristics and Psychosocial Health of Transgender People

acronym: DyGeDem

summary: To study demographic characteristics of subjects referred to endocrine care for gender dysphoria and their psychosocial health


title: Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity

summary: There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.


title: Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

summary:
The frequency of cardiac implantable electronic devices (CIED) is constantly increasing.

Devices infections are one of the most serious complications in terms of morbidity and mortality. Although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing.

The infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical, biological and multimodal imagery data. Early diagnosis and specific management are necessary to reduce mortality and morbidity.

Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm Society of patient described an algorithm to treat CIED infections and extraction indications.

However, in practice, management of CEID infections remains center-dependent and data from robust international studies are missing.

The main objective of our study is to evaluate the management of CEID suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the Nancy University Hospital and to compare the treatment with the latest recommendations in force

ReferenceCitation: Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.

ReferenceCitation: Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.

ReferenceCitation: Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.

ReferenceCitation: Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available. Erratum In: Heart Rhythm. 2021 Oct;18(10):1814.

ipd_sharing_description: Anonymous individual datas for baseline characteristcs and clinical outcomes would be available


title: Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

summary: The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.


title: Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

acronym: NutriCoviDom

summary:
Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments

ReferenceCitation: Quilliot D, Gerard M, Bonsack O, Malgras A, Vaillant MF, Di Patrizio P, Jaussaud R, Ziegler O, Nguyen-Thi PL. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors. BMJ Open. 2021 Jul 14;11(7):e048948. doi: 10.1136/bmjopen-2021-048948.


title: Physiological and Psychological Responses to Stress in Year 6 Medical Students Faced to Ambulatory Symptomatic Patients

summary:
Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative stressors (patient's expectations about explanations) and task contingent stress due to time pressure, the necessity to take into account patient's mood, to deal with uncertainty of their own data collection and with complex clinical situations. In France, excepted for family medicine, undergraduate medical students and residents are currently not trained to perform consultations and are never exposed to ambulatory patients during training. The investigators postulate that this lack of practice may generate a significant state of stress during the first consultations and consequently modify or even impair clinical reasoning.

The primary objective of this study is to compare subjective and physiological levels of acute stress in ambulatory versus hospitalization setting in medical students confronted to a real patient with a diagnostic problem.

Measures: The French version of the Anxiety Spielberger test is administered just before and after each problem solving session.

Cortisol salivary samples are taken before and after each problem solving session. Salivary cortisol levels have been shown to be correlated to stressful situations and some personality traits but with some difference according to gender.

Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of primary appraisal to secondary appraisal according to Tomaka et al.

lead_sponsor: Nantes University Hospital


title: Impact of a Permanently Maintained Healthcare Multidisciplinary Facility Named Permanece d'Accès Aus Soins de Santé (PASS-MULTI) on Unscheduled Readmissions at 12 Months for Persons in Precarious Situations.

acronym: PASS-MULTI

summary:
Created in 1998, PASS departments are mostly intrahospital structures providing primary care to vulnerable patients.

The main objective of the project will be to measure the impact of a multidisciplinary PASS benefiting from outpatient pharmaceutical interviews on the rate of unplanned rehospitalization of patients in precarious situations.

The impact of the implementation of such a device will also be measured on other indicators of major interest in the course of care of the precarious patient: average lengths of stay, emergency room, improved continuity of treatment, quality of life of the patient related to his health, medication compliance, effective accessibility to social rights, qualitative improvement in the use of care, medico-economic efficiency of the intervention compared to existing practice.

The study will be multicenter: 6 centers spread throughout France (Marseille, Paris, Nice, Toulouse, Poitiers and Bayonne).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Prospective Study of Patients Treated for Bone and Joint Infection (BJI) Due to Staphylococcus Aureus, Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI

acronym: ESPRI-IOAC

summary:
There are more than one million (> 40,000 cases per year in France) of osteoarticular infections (OAI) yearly in the world. The number of these infections is constantly increasing due to an increase in life expectancy associated with an increase in prosthesis fitting, as well as an increase in comorbid factors. These are severe pathologies associated with mortality (5%) and significant morbidity (40%), responsible for functional sequelae with an individual cost (prolonged hospitalization, altered quality of life, disability) and societal (sick leave, partial disability). or total, temporary or permanent) extremely high. In addition, reinfection rates within two years of treatment are high.

The BJIs are a group of clinical entities that have in common the invasion and progressive destruction of bone and cartilage tissue by bacterial-like microorganisms.

Staphylococcus spp is the main pathogen (>50%) in BJI and is associated with particularly difficult to treat infections, with a high rate of chronicity and relapses, especially in case of implanted material.

The difficulty in managing these infections is partly linked, on the one hand, to the fact that the pathogens are in "persistent" metabolic forms and in intracellular reservoirs which make them insensitive to conventional antibiotics and, on the other hand, the absence of reliable markers of the infection and above all of its clinical resolution, which complicates clinical trials.

ESPRI-IOAC is a consortium of 4 partners (private-public) from Lyon area and which aims at:

studying the translational value of BJI preclinical models
identifying biomarkers of infection in preclinical models and at assessing them in a prospective study.

The current study is part of the global ESPRI-IOAC consortium, and represent the clinical application.

It is a prospective study of patients treated for BJI in the infectious disease department of the Hospices Civils de Lyon, La Croix-Rousse, for osteo-articular infections due to Staphylococcus aureus, or for simple mechanical revision or for cruciate ligament surgery, the objective of which is to highlight biomarkers of interest in the diagnosis of chronic BJI and, or predictive of the therapeutic response.

The translational value of the experimental models used in the BJI will also be studied.

status: Terminated

lead_sponsor: Hospices Civils de Lyon


title: Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

summary: Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.

intervention_type: Diagnostic Test


title: Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis

summary: Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis


title: Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life

acronym: EXCLUFAT

summary:
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases.

Currently, only 30% of women who have undergone a mastectomy choose reconstruction.

The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics.

There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions.

Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction.

Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications.

Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients.

However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study.

The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.

lead_sponsor: Institut Cancerologie de l'Ouest

lead_sponsor_type: industriel


title: How to Improve the Care of Elderly People From Nursing Home: Interventional Research With Mixed Methods on an Early Integrated Palliative Approach

summary:
The national context of the end of life of elderly people living in Nursing Home (NH) is concerning.

A quarter of NH residents die each year representing a quarter of annual deaths in France of all ages. The number of resident deaths arises (148,300 deaths in 2015 versus 124,500 in 2011). In fact, the age of residents welcomed in NH increase, 82% of residents are 80 years old and over, suffering from several chronic pathologies, some of which are serious and incurable. These are the main cause of death for residents. The advancing age of NH residents and the interweaving of multiple chronic conditions and disabling pathologies generate complex care needs, the complexity of which undermines the current system of care organization. In 2016, 59% of NH residents were severely dependent in their activities of daily living (ADL) and instrumental activities of daily living (IADL) according to the French scale Autonomie, Gérontologie Groupe Iso Ressources, (1 the most dependant to 6 the less dependent); the majority of these most dependent NH residents (80% of Groupe Iso-Ressource 1-2 in 2011) had at least one unstable chronic pathology and 73% of deceased residents (in 2015) come from this group whose level of dependence is very high.

Palliative care (PC), which is care focused on maintaining quality of life in a context of incurable and complex pathology, therefore appears to be indicated in the context of NH. However, residents' access to PC remains limited, uneven and late. The number of residents requiring this support is estimated at more than 100,000 residents per year. The consequences of such situation are serious, first with regard to the quality of life of NH residents and their family caregivers, but also the inappropriate use of health services (as shown by the excessive use of emergency department and unscheduled hospitalizations) and work life for care providers in NH is affected (care providers suffer from a lack of support when faced with the difficulties of caring for NH residents at the end of their life). However, these consequences are potentially avoidable by means of adapted organizational solutions. The implementation of an integrated and early palliative approach (IEPA) in care pathway of patient is one of the solutions recommended by the World Health Organization and the French National Authority for Health. Several studies have shown the benefit of such approach in the management of cancer patients. However, the transferability and effectiveness of this approach in other organizational and population contexts are poorly documented, particularly in NH settings.

The main objective is to evaluate, through a pragmatic controlled trial the effectiveness of an Early Integrated Palliative Care Approach in usual NH context (EIPCA-NH) on the quality of care in NH for elderly in need of PC. The secondary objectives concern:

the implementation process of the EIPCA-NH: i) measure the degree of implementation of the EIPCA-NH in each site, ii) identify and understand the factors (individual and organizational) facilitating or limiting the success of the implementation process of an IEPA according to NH contexts (inter-site comparison).
the effects of the EIPCA-NH in the NH : i) on the quality of life of residents requiring PC and ii) that of their family caregivers, iii) on the quality work life of professional caregivers and iv) on the care pathway of NH residents.

A mixed methods research, with qualitative and quantitative approach, will be carried out in at least 20 NH in three different health territories. These NH will benefit from a EIPCA-NH intervention which consists of 1) implementing a mechanism for sharing and co-producing knowledge, 2) integrating this approach as early as possible in the care of residents. This study is based on a multicenter, randomized crossover cluster-type stepped-wedge study, running on 4 years in order to measure the sustainability of EIPCA-NH; the quantitative analysis of the effectiveness of EIPCA-NH will focus on an open cohort of 3,500 residents receiving the intervention. The qualitative component will consist of a multiple case study to analyse the process of implementation and production of the EIPCA-NH. The integrative analysis of qualitative and quantitative data will allow a better understanding of the causal mechanisms of the observed phenomena.

This project will provide evidence on the value of EIPCA and the conditions for its implementation and transferability. The proposed intervention will help improve care practices for all NH residents (600,000 people). The approach by co-construction between actors of the thousands of care structures (NH, cities, hospitals) and researchers should promote a better representation of PC, promote the culture of anticipation, evaluation and collaboration between actors of in- and out- NH, contributing to a better synergy of intersectoral and territorial actions of the supply of health services.

primary_purpose: Health Services Research

lead_sponsor: Maison Médicale Jeanne Garnier

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

collaborators: École de santé publique Université de Montréal

collaborators: Centre Hospitalier Henri Duffaut - Avignon

collaborators: Agence Regionale de Sante d'Ile de France

location_facility:
Maison Médicale Jeanne Garnier
Ch Avignon
Maison de Santé Marie Galène


title: Quality of Life Comparison in Patients With Different Types of Alopecia

acronym: RDACCQV

summary: Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Behavioral


title: Diagnostic Performance Comparison Between Procalcitonin-based vs. ANAES-based Guidelines; Impact on Antibiotic Use in Newborns With Suspected Early-onset Neonatal Infection (EONI)

acronym: DIACORD

summary:
Neonatal bacterial infection remains a serious pathology in industrialized countries despite the use of prophylaxis measures for group B streptococcus (GBS) (peri-partum antibiotic in women with GBS colonization), which was implemented in the United States in 1996 and in France in 2001 and has led to a dramatic decrease in the incidence of neonatal bacterial infections. However, early onset neonatal infection (EONI), which is defined as an infection occurring during the first 6 days after birth (as opposed to late onset neonatal infections (LONI) occurring between days 7-89), is still one of the leading causes of neonatal morbidity and mortality. Physicians consider EONI a significant diagnostic and therapeutic emergency due to the potential for sudden onset and rapid evolution of sepsis in newborns with immature immune systems. Currently, in France, detection of EONI is based on national consensus guidelines published in 2002 (ANAES recommendations). There are broad indications to provide empirical antibiotic treatment pending diagnostic confirmation through different complementary exams. To ensure that every infected newborn is diagnosed, biological assessments are often repeated and result in the use of invasive and painful procedures, anemia and financial concerns. Moreover, in cases of abnormal biological results, many newborns are subjected to intravenous (IV) antibiotic treatments requiring hospitalization and separation from their mother. However recent studies have shown that antibiotics can have a potentially deleterious effect on the neonatal digestive microbiota and result in the appearance of antibiotic-resistant bacteria, with possible long-term consequences on the health of the child.

Procalcitonin (PCT) is a calcitonin prohormone secreted from the parenchymal tissues. This marker of inflammation has been shown to be a valuable diagnostic marker for bacterial infection in adults and in children. It also seems to be a reliable marker for neonatal bacterial infection, which would make it useful in the detection of EONI. Because physiological levels of PCT vary during the first days of life, possibly due to postnatal intestinal bacterial colonization, levels of this marker are difficult to interpret in the early neonatal period. However, in a study of 2151 newborns with suspected EONI, Nicolas Joram et al. found that PCT obtained from the umbilical blood cord, prior to newborn intestinal colonization, bypasses this postnatal physiological peak of PCT and effectively constitutes a discriminant marker to distinguish between infected and healthy infants using a cutoff value of 0.6 ng/ml.

Subsequent to this pilot study, several studies on PCT in umbilical blood cord confirmed its good diagnostic performance for EONI, particularly when included in a diagnostic algorithm. This marker could contribute to a better estimation of EONI risk in order to limit the use of unnecessary complementary exams and prescription of antibiotics and their associated short- and long-term side effects in healthy newborns.

Therefore, in this study, the investigators propose to test the diagnostic value of a PCT-based algorithm in newborns suspected of having EONI. The investigators hypothesize that this algorithm is as efficient as those currently used (ANAES), but will limit coinciding biological exams and exposure to antibiotics during the neonatal period.

sponsor_collaborators:
Nantes University Hospital
University Hospital, Tours
University Hospital, Brest
Rennes University Hospital
Poitiers University Hospital
University Hospital, Angers
University Hospital, Bordeaux
Centre Hospitalier de Bretagne Sud
University Hospital, Paris
Créteil Hospital
Nantes Polyclinic

location_facility: Private clinic - Polyclinique de l'Atlantique

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: DIACORD

titre: Evaluation de la performance diagnostique d'un nouvel algorithme dans la prise en charge des suspicions d'infection materno-ftale, impact sur l'exposition aux antibiotiques et aux actes invasifs des nouveau-nés.

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: GRAS LE GUEN

prenom_porteur: Christèle


title: Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery

acronym: RELASTANCE

summary:
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.

The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.

Patients will be considered fluid responders if an increase >10% of the stroke volume is observed .

ReferenceCitation: Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.

ReferenceCitation: Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare((R))/PRAM versus echocardiography for cardiac output estimation in vascular surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1114-21. doi: 10.1053/j.jvca.2013.04.017. Epub 2013 Sep 19.

ReferenceCitation: Gopal S, Do T, Pooni JS, Martinelli G. Validation of cardiac output studies from the Mostcare compared to a pulmonary artery catheter in septic patients. Minerva Anestesiol. 2014 Mar;80(3):314-23. Epub 2014 Jan 8.

ReferenceCitation: Messina A, Romano SM, Bonicolini E, Colombo D, Cammarota G, Chiostri M, Della Corte F, Navalesi P, Payen D, Romagnoli S. Cardiac cycle efficiency and dicrotic pressure variations: new parameters for fluid therapy: An observational study. Eur J Anaesthesiol. 2017 Nov;34(11):755-763. doi: 10.1097/EJA.0000000000000661.

ReferenceCitation: Monge Garcia MI, Guijo Gonzalez P, Gracia Romero M, Gil Cano A, Oscier C, Rhodes A, Grounds RM, Cecconi M. Effects of fluid administration on arterial load in septic shock patients. Intensive Care Med. 2015 Jul;41(7):1247-55. doi: 10.1007/s00134-015-3898-7. Epub 2015 Jun 11.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10. Erratum In: J Appl Physiol. 2009 Mar;106(3):1027.

ReferenceCitation: Sunagawa K, Maughan WL, Burkhoff D, Sagawa K. Left ventricular interaction with arterial load studied in isolated canine ventricle. Am J Physiol. 1983 Nov;245(5 Pt 1):H773-80. doi: 10.1152/ajpheart.1983.245.5.H773.

ReferenceCitation: Guarracino F, Baldassarri R, Pinsky MR. Ventriculo-arterial decoupling in acutely altered hemodynamic states. Crit Care. 2013 Mar 19;17(2):213. doi: 10.1186/cc12522. No abstract available.

ReferenceCitation: Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15. doi: 10.1536/ihj.10.509. No abstract available.

ReferenceCitation: Guarracino F, Ferro B, Morelli A, Bertini P, Baldassarri R, Pinsky MR. Ventriculoarterial decoupling in human septic shock. Crit Care. 2014 Apr 24;18(2):R80. doi: 10.1186/cc13842.

ReferenceCitation: Morelli A, Singer M, Ranieri VM, D'Egidio A, Mascia L, Orecchioni A, Piscioneri F, Guarracino F, Greco E, Peruzzi M, Biondi-Zoccai G, Frati G, Romano SM. Heart rate reduction with esmolol is associated with improved arterial elastance in patients with septic shock: a prospective observational study. Intensive Care Med. 2016 Oct;42(10):1528-1534. doi: 10.1007/s00134-016-4351-2. Epub 2016 Apr 21.

ReferenceCitation: Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20(1):270. doi: 10.1186/s13054-016-1439-6.

ReferenceCitation: Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.

intervention_type: Drug


title: Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia

summary:
The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).

The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.

ReferenceCitation: Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.

ReferenceCitation: Nieman GF, Al-Khalisy H, Kollisch-Singule M, Satalin J, Blair S, Trikha G, Andrews P, Madden M, Gatto LA, Habashi NM. A Physiologically Informed Strategy to Effectively Open, Stabilize, and Protect the Acutely Injured Lung. Front Physiol. 2020 Mar 19;11:227. doi: 10.3389/fphys.2020.00227. eCollection 2020.

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Predictive Factors for the Results of Epiphysiodesis in Limb Length Discrepancy

summary:
Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery.

The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care.

The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.


title: Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room

acronym: HYPNACESS

summary:
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.

Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.

The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.

The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.

The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.

ReferenceCitation: Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.

ReferenceCitation: Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.

ReferenceCitation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

ReferenceCitation: Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois 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. doi: 10.1097/00000542-200506000-00010.


title: Hepatic Artery From Origin to Segmental Branching: a 500 Case CT Study

summary:
The origin of the hepatic artery is known to be highly variable, as reported by Michels in 1966 and other authors. This variability has an indisputable impact regarding hepatic, pancreatic and upper gastro-intestinal surgery.

As the investigators go deeper into the liver's parenchyma, full-liver and segment IV studies have also found high levels of variability. Only few cadaveric studies have analyzed the entire liver and with limited sample size.

The current CT technology allows for an accurate analysis of the arterial branching thanks to the 0.625mm voxel.

The aim of this CT study is to describe the anatomy of hepatic arterial segmental branching from the origin of the hepatic artery.


type: Other Identifier

title: T1 Mapping in Diagnosis and Follow up of Fabry Disease

acronym: MAP-FAB

summary:
Fabry disease (OMIM-301500, FD) is a lysosomal storage disease with X-linked inheritance secondary to mutations in the α-galactosidase A gene (GLA), which cause absence or decreased activity of the lysosomal hydrolase a-galactosidase A (a-gal A). The accumulation of globotriaosylceramide (Gb3) leads to multiple organs dysfunction, especially in three key organs: kidney, heart and cerebrovascular system. Progressive nephropathy is one of the main features of Fabry disease and is marked by an insidious development. The investigators are facing different current challenges about treatment initiation in non-classic phenotype patients, optimal dose after treatment initiation, and treatments monitoring in Fabry nephropathy. That is even more important that the enzyme replacement therapy is expensive and a lifelong commitment.

Functional magnetic resonance imaging (MRI) is now able to provide T1 mapping sequence. In Fabry disease, T1 mapping is currently used to assess the degree of myocardial involvement. The MRI for assessement of Fabry Cardiomyopathy is now recommended by the 2022 national diagnostic and care protocol (PNDS) in France. However there is no data about T1 mapping values in kidney in Fabry's disease The main Objective is to describe renal performance through multi-parametric MRI in Fabry nephropathy and the primary outcome will be the quantification of renal T1 in Fabry patients.

status: Recruiting

location_facility:
Hopital Femme Mère Enfant
Hopital Edouard Herriot


title: Comparison of Strategies Based on RT-PCR or Antigenic Test for the Screening of SARS-CoV-2 Infection in General Population Using Self-samples (COVID-19).

acronym: AutoCoV

summary: The virological diagnosis of SARS-CoV-2 infection is pivotal for the control of the outbreak by large screening of a- or pauci-symptomatic subjects. Despite nasopharyngeal swabbing tested by RT-PCR is considered as the gold standard, new strategies based on self-samples are considered as valuable alternatives because of their non-invasiveness and ability to be performed in the absence healthcare worker, especially when the subject is asymptomatic and needs to be tested repetitively. The aim of the present project is to evaluate two strategies both based on self-samples: (i) a saliva sample combined to an anterior nare self-swabbing tested by antigenic test versus (ii) a saliva sample tested by RT-PCR. The comparison will be performed during a mass screening of the population of the city of Saint-Etienne (170000 inhabitants), France. The sensitivity of the rapid antigenic test will be evaluated in comparison to that of RT-PCR considered as gold standard.

ReferenceCitation: Verot E, Bonjean P, Chaux R, Gagnaire J, Gagneux-Brunon A, Pozzetto B, Berthelot P, Botelho-Nevers E, Chauvin F. Development and Validation of the COVID-19 Knowledges and Behavior Questionnaire in a French Population (CoVQuest-CC). Int J Environ Res Public Health. 2022 Feb 23;19(5):2569. doi: 10.3390/ijerph19052569.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

publisher_dissemination: MDPI

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Benefit of Hypnosis on Smartphone for Acute Post-operative Pain

summary:
Appendicitis is a common pathology and the one of the most common surgical procedures performed in France. Young subjects are the most frequent patients with appendicitis. Appendicular peritonitis increases post-operative pain, morbidity, and the average length of hospital stay compared to uncomplicated appendicitis.

Pain alters perioeprative rehabilitation of patients. Surgery, performed urgently, generates more anxiety and pain than scheduled surgery. But, intensity of chronic postoperative pain is in correlation to intensity of acute postoperative pain. In addition, admission of emergency cases is more axiety-inducing, due to wait times, packed emergency room, worklaod of medical staff.

Sex and age also modify perception of postoperative pain. Adults under 50 feel more pain than older patients for similar procedures.

Medication for pain is required in perioperative period et is administered according protocol of each medical center ; these protocols include analgesics, opioids or not, benzodiazepine... However, opioids analgesic (example: morphine) can induce side effect, such as confusional syndrome, cardio-pulmonary manifestations, ileus, nausea and vomiting...

Non-pharmacological approaches have been also proposed to reduce anxiety and pain. Hypnosis is frequently used but not always adapted to the emergency: need for qualified and available staff, environment not conducive to hypnotic induction...

Hypnosis is a modified state of consciousness ; it is neither a state of vigilance nor a state of sleep. Several types of hypnosis can be distinguished according to the medical application, such as hypnoanalgesia or hypnosedation.

Using hypnosedation during surgical or invasive procedure can reduce the use of painkillers and sedatives. Interest of hypnosis has been observed for extraction of wisdow teeth, delivery...

Young patients are very comfortable with the use of their smartphone which is often the first object recovered when they return from the operating room. Many hypnosis videos are available free of charge on Internet, and some of which are produced by specialized practitioners and university teachers.

A recent study has shown that among young people, addiction to smartphone is a predisposition to hypnosis.

However, the use of hypnosis videos on smartphone has never been studied for the control of postoperative pain.

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital

summary:
Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder.

In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system

ReferenceCitation: Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

ReferenceCitation: Edvardsson N, Wolff C, Tsintzos S, Rieger G, Linker NJ. Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. Europace. 2015 Jul;17(7):1141-8. doi: 10.1093/europace/euu412. Epub 2015 Mar 10.

ReferenceCitation: Padmanabhan D, Kancharla K, El-Harasis MA, Isath A, Makkar N, Noseworthy PA, Friedman PA, Cha YM, Kapa S. Diagnostic and therapeutic value of implantable loop recorder: A tertiary care center experience. Pacing Clin Electrophysiol. 2019 Jan;42(1):38-45. doi: 10.1111/pace.13533. Epub 2018 Dec 4.

ipd_sharing_description: anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available


title: Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study

summary:
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity.

Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature.

Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied.

If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk.

The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction


title: Bone Fragility Evaluation by Dual X-Ray Absorptiometry (DXA) and CT-scan (Vertebral Fracture and Scanographic Bone Attenuation Coefficient of the First Lumbar Vertebra SBAC-L1) in Obese Patients

summary: This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

ReferenceCitation: Murray TE, Williams D, Lee MJ. Osteoporosis, obesity, and sarcopenia on abdominal CT: a review of epidemiology, diagnostic criteria, and management strategies for the reporting radiologist. Abdom Radiol (NY). 2017 Sep;42(9):2376-2386. doi: 10.1007/s00261-017-1124-5. Erratum In: Abdom Radiol (NY). 2017 Aug 5;:

ReferenceCitation: Walsh JS, Vilaca T. Obesity, Type 2 Diabetes and Bone in Adults. Calcif Tissue Int. 2017 May;100(5):528-535. doi: 10.1007/s00223-016-0229-0. Epub 2017 Mar 9.

ReferenceCitation: Hammoud E, Toumi H, Jacob C, Pinti A, Lespessailles E, El Hage R. Does the Severity of Obesity Influence Bone Mineral Density Values in Premenopausal Women? J Clin Densitom. 2021 Apr-Jun;24(2):225-232. doi: 10.1016/j.jocd.2019.04.006. Epub 2019 Apr 26.

ReferenceCitation: Bauer JM, Cruz-Jentoft AJ, Fielding RA, Kanis JA, Reginster JY, Bruyere O, Cesari M, Chapurlat R, Al-Daghri N, Dennison E, Kaufman JM, Landi F, Laslop A, Locquet M, Maggi S, McCloskey E, Perna S, Rizzoli R, Rolland Y, Rondanelli M, Szulc P, Vellas B, Vlaskovska M, Cooper C. Is There Enough Evidence for Osteosarcopenic Obesity as a Distinct Entity? A Critical Literature Review. Calcif Tissue Int. 2019 Aug;105(2):109-124. doi: 10.1007/s00223-019-00561-w. Epub 2019 May 16. Erratum In: Calcif Tissue Int. 2019 Jul 23;:

ReferenceCitation: Jammah AA. Endocrine and metabolic complications after bariatric surgery. Saudi J Gastroenterol. 2015 Sep-Oct;21(5):269-77. doi: 10.4103/1319-3767.164183.

ReferenceCitation: Hong CS, Bergen MA, Watters TS. Transient osteoporosis of the hip after bariatric surgery. Arthroplast Today. 2018 Dec 7;5(1):32-37. doi: 10.1016/j.artd.2018.10.010. eCollection 2019 Mar.

ReferenceCitation: Lespessailles E, Hammoud E, Toumi H, Ibrahim-Nasser N. Consequences of bariatric surgery on outcomes in rheumatic diseases. Arthritis Res Ther. 2019 Mar 28;21(1):83. doi: 10.1186/s13075-019-1869-z.

ReferenceCitation: Santos D, Lopes T, Jesus P, Cruz S, Cordeiro A, Pereira S, Saboya C, Ramalho A. Bone Metabolism in Adolescents and Adults Undergoing Roux-En-Y Gastric Bypass: a Comparative Study. Obes Surg. 2019 Jul;29(7):2144-2150. doi: 10.1007/s11695-019-03797-5.

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ReferenceCitation: Madsen LR, Espersen R, Ornstrup MJ, Jorgensen NR, Langdahl BL, Richelsen B. Bone Health in Patients with Type 2 Diabetes Treated by Roux-En-Y Gastric Bypass and the Role of Diabetes Remission. Obes Surg. 2019 Jun;29(6):1823-1831. doi: 10.1007/s11695-019-03753-3.

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title: Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision

acronym: PREVISION

summary: Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.


title: Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives

summary:
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient.

The objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.

time_perspective: Other

collaborators: Société Francophone Nutrition Clinique et Métabolisme


title: Is Precariousness a Risk Factor for COVID-19 Mortality in Intensive Care?

summary:
Is precariousness a risk factor for COVID-19 mortality in intensive care units ?

Abstract

Background: During the SARS-CoV-2 pandemic, the first wave overwhelmed hospitals in Paris area (Ile-de-France) with a variable impact depending on the territory. Several studies highlighted variable ICU mortality rates during COVID-19 surges across territories (10 to 60%) with higher rates in those most affected by poverty. We assessed the impact of precariousness, as an independent risk factor, on mortality linked to Covid-19 between ICUs at Delafontaine hospital and Ambroise Paré hospital.

Method: Investigators carry out a retrospective observational cohort study of consecutive ICU patients aged ≥ 18 years admitted at Delafontaine and Ambroise Paré hospitals during the first wave of the Covid-19 outbreak in order to compare mortality rates according to predefined risk factors (age, diabetes, arterial hypertension, BMI, active solid or haematological cancer, IGS2, poverty rate at the threshold of 60% (%) according to the island grouped for statistical information (IRIS)37 of the patient, invasive ventilation or not) that include precariousness.

Results:

Conclusion:

ipd_sharing_description: Data collection file will be available in article supplementary material

lead_sponsor: Centre Hospitalier de Saint-Denis


title: Qualitative Evaluation of Therapeutic Alliance in Adolescent Psychiatry: Crossing Perspectives of Adolescents, Parents and Physicians

acronym: EVAADO

summary:
Context: Psychiatric disorders (anorexia nervosa, depression, anxiety based school refusal) are a major public health concern in adolescence. Their treatment is a challenge for the families, the health care system and society. The treatment is complex and non-standardized. In clinical practice, the relational dimension between the stakeholders is recognized by all. Nevertheless no study has ever crossed their perspectives about therapeutic alliance in adolescent psychiatry.

Objective: to explore, within a qualitative approach, how a therapeutic alliance is established in three different clinical situations according to the adolescents, their parents and their physicians by crossing their perspectives.

Methods: This is a national (France) multi-center qualitative study based on 180 semi-structured interviews. Participants (purposively selected until data saturation) came from three different sub-samples: (i) adolescents with anorexia nervosa (N =20) plus their parents (N=20) and their physicians (N=20), (ii) adolescents with depressions (N=20) plus their parents (N=20) and their physicians (N=20), and (iii) adolescents with anxiety-based school refusal (N=20) plus their parents (N=20) and their physicians (N=20). Data are collected through open ended semi structured interviews and independently analyzed with NVivo V.11 software by three researchers according to the principles of Interpretative Phenomenological Analysis.

lead_sponsor: Centre Hospitalier Victor Dupouy

location_facility:
CHVictorDupouy
CHU Rouen

appel_a_projets: PREPS

nom_etablissement: CH  VICTOR  DUPOUY  ARGENTEUIL

acronyme: EVAADO

titre: Evaluation de l'Alliance thérapeutique en psychiatrie de l'adolescent: étude qualitative des perspectives croisées des adolescents, des parents et des médecins

discipline_principale: psychiatrie / addictologie

nom_porteur: REVAH LEVY

prenom_porteur: Anne


title: Feasibility Study for Improving the Relevance of Diagnostic Proposals for an Artificial Intelligence Software in the Elderly Population.

summary:
The ageing of the population is accompanied by the problem of chronic pathologies and sometimes heavy dependence, requiring admission to Nursing Homes (NHs). Approximately 660,000 people currently live in NHs in France. One out of 3 NHs does not have a coordinating doctor, even though the law requires it, and access to care in these NHs is very unequal nationally and especially in the Limousin and Dordogne regions. Some Hospices may find themselves in a situation where there is no coordinating doctor and difficult access to General Practitioners (GPs) visiting a large area.

This inequality of access to care results in a difference in care that can go as far as a loss of opportunity for residents who are immediately transferred to the emergency department (ED) with a risk of iatrogeny or delirium once in the ED or a risk of inappropriate hospitalization.

Residents are hospitalized:

when the latter could have been avoided because the health care team, not knowing what attitude to adopt, prioritized hospitalization
Late because the resident waited for the attending physician to come, which resulted in a worsening of symptoms.

The arrival of Artificial Intelligence (AI) is an opportunity to find new models of care organization that can mitigate medical desertification but also develop advanced practices in gerontology. For example, nurses will be able to intervene at a first level for early detection, better triage and early management of certain pathologies.

The "MEDVIR society" AI, developed by a French company, is a medical decision support system with Artificial Intelligence and offers pre-diagnosis based on the information collected (medical and surgical history, concomitant treatments and symptoms). MEDVIR is a diagnostic aid tool and does not replace the doctor who remains at the end of the chain, the final decision-maker.

Before research is conducted to integrate this technology into routine care, it is important to validate the diagnostic relevance of AI in the elderly, as it has been validated in the general population.

This pilot feasibility study will then enable us to methodologically dimension a future project to evaluate the efficiency of this new care system in the management of elderly patients in medical deserts in France.

lead_sponsor: University Hospital, Limoges

location_facility:
Ehpad Des Bayles
Ehpad Le Roussillon


title: Register of Patients Benefiting From a Coronary Bifurcation Angioplasty at the University Hospital of Nîmes and Montpellier in 2017

acronym: Register

summary:
Cardiovascular diseases are the second leading cause of death in France and the world's leading cause.Coronary bifurcations are conducive to the development of atheromatous lesions due to flow turbulence generating a pro-atherogenic effect. They represent about 15% of coronary lesions and 30% of lesions in pluri truncular patients.Coronary bifurcation angioplasty is a complex angioplasty with a high risk of complications.Numerous studies have compared different angioplasty techniques with 2 stents in bifurcation lesions. However, two studies of The Nordic-Baltic Bifurcation Study did not show at 6 months or 5 years of age any significant difference in major cardiovascular events (death, heart attack, stent thrombosis, emergency revascularization of the target vessel) in patients with a one-stent strategy compared to the systematic use of two stents. There are also several post-expansion techniques and the one that appears to be the most commonly used today (known as the "KISSING-BALLOON") consists of inflating two balloons at the same time, one in the main branch and the other in the daughter branch in order to open the meshes of the stent towards the daughter branch. Studies on a test bench to evaluate the deformation of a stent in different coronary anatomies according to the material and technique used have nevertheless revealed several limitations to this technique, in particular an elliptical deformation of the stent linked to the inflation of 2 simultaneous balloons.

From this work, a new technique known as "POT SIDE POT" was born, consisting in post dilating the proximal part of the stent of the main branch in order to place it as closely as possible against the wall, then open the stent meshes towards the lateral branch by balloon dilation followed by a new post dilation of the proximal part of the mother branch stent to avoid the use of 2 simultaneous balloons and thus reduce stent deformation by maintaining a circular geometry while allowing proper stent attachment.

However, to date, there are no clinical studies comparing the POT SIDE POT technique with that of KISSING-BALLOON in coronary bifurcation angioplasty.

This is why we would like to compare these two post-dilation techniques by a retrospective study on the occurrence of major cardiovascular events and stent thrombosis in patients who received a coronary bifurcation angioplasty in 2017 at the University Hospital of Nîmes.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization

acronym: TRACE

summary:
Patients with terminal chronic kidney disease (CRD) need renal function supplementation, namely dialysis or renal transplantation. Transplantation is the most efficient and cost-effective treatment. Early and equitable access to transplantation is a public health issue. Access to transplantation is facilitated by early and systematic information and assessment of patients for inclusion in the national waiting list for transplantation prior to the onset of dialysis, and by the development of transplantation from living donors. In France, there are wide disparities in access to national waiting list registration and transplantation. One of the causes of these inequalities in access would be the disparity in referral practices to a transplant medical and surgical team authorized to register the individual on the national waiting list.

The aim of the TRACE study is to evaluate the impact of a new regional organization promoting renal transplantation on access to renal transplantation.

location_facility: Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: TRACE

titre: Favoriser l'accès à la transplantation rénale : impact d'une organisation régionale centrée sur le patient.

discipline_principale: néphrologie

nom_porteur: PASTURAL THAUNAT

prenom_porteur: Myriam


title: A Non-interventional Study Evaluating the Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger Than 40 Years (ARTEMIS)

acronym: ARTEMIS

summary:
Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40.

The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1).

The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists.

Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s).

The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility.

The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients.

The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.

lead_sponsor: Hôpital Privé des Côtes d'Armor (HPCA)


title: Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology, Dermatology and Rheumatology Departments of the University Hospital of Besançon

acronym: MISTIC

summary: Patients with chronic inflammatory diseases (CID) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease [MC] and ulcerative colitis [RCH]), chronic inflammatory skin diseases (psoriasis or Verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis [RA] and spondyloarthritis [SpA] including psoriatic arthritis [PsA]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Assessment of the Prevalence of Analgesics Opioid Misuse in Chronic Non-cancer Pain Patients

summary: Chronic pain is a worldwide health problem due to its high prevalence and its difficult management with a significant impact on quality of life. Pain and addiction co-occur frequently. Indeed, the prevalence of addiction in patients with chronic non-cancer pain may affect from 0% to 50% of patients (Højsted et al 2010). This large variability in the estimation of addiction prevalence in chronic non-cancer pain patients is at least partly due to a lack of standardization of the selected patients from the clinical or therapeutic point of view and the lack of consensus in the use of a specific evaluation tool or gold standard. Indeed, several tools are currently available at the international level with varying efficiencies and precisions (Chou et al 2009, Turk, Swanson, and Gatchel 2008, Højsted and Sjøgren 2007). In France, no data are available on the prevalence of analgesic opioid misuse in chronic non-cancer pain patients, due to the lack clinical studies and validated tools in French.

ReferenceCitation: Kerckhove N, Delage N, Bertin C, Kuhn E, Cantagrel N, Vigneau C, Delorme J, Lambert C, Pereira B, Chenaf C, Authier N; Poma Network. Cross-sectional study of the prevalence of prescription opioids misuse in French patients with chronic non-cancer pain: An update with the French version of the POMI scale. Front Pharmacol. 2022 Sep 5;13:947006. doi: 10.3389/fphar.2022.947006. eCollection 2022.

publisher_dissemination: Frontiers

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
CEIP-A Lyon
CEIP-A Marseille
CEIP-A Caen
CEIP-A Lille
CEIP-A Montpellier
CEIP-A Nantes
CEIP-A Poitiers
CEIP-A Toulouse
CEIP-A Bordeaux


title: Early-onset and Late-onset Sporadic Alzheimer's Disease (AD) : Variations of the Clinical Profile and Paraclinical Features Depending on the Age at the Onset of Clinical Signs

summary: Alzheimer's disease (AD) is usually associated with aging, age being the principal identified risk factor. However, younger subjects also develop AD and the prevalence of early onset AD is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age of 65 in France. There is evidence that early onset AD differs from AD in older patients. In particular, clinical and neuroimaging studies suggest early involvement of neocortical brain regions and their functions in early onset AD, while mediotemporal areas and memory might be more involved in late onset AD. These differences could partly explain the atypical clinical and imaging features of younger patients, the diagnostic difficulties in these patients and the specific problems related to medical care of this age group. The present study uses a multidisciplinary approach with longitudinal followup in order to establish the impact of age on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another aim of the project is to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Evaluation of the Occurence of Thrombotic and Bleeding Events After Coronary Angioplasty With Stent According to Aspirin and Clopidogrel Platelet Reactivity Assessed by a Point of Care Assay in the Cathlab (the Verifynow French Registry)

acronym: VERIFRENCHY

summary:
The purpose of this study is to determine the effect of clopidogrel or aspirin reactivity as measured by a point-of-care platelet function assay on thrombotic or bleeding events after percutaneous coronary intervention (PCI) with drug eluting or bare metal stent.

Methods:

Platelet reactivity on clopidogrel and aspirin therapy is measured before PCI with VerifyNow (Accumetrics Inc.,San Diego, CA, USA) P2Y12 or aspirin assay respectively in 1000 consecutive patients from 20 centers in France undergoing coronary angioplasty with stent.

Exclusion criteria are:

Acute myocardial infarction, treatment with vitamin K antagonists and the use of antiGP2b3a before PCI. All patients are pre-treated with clopidogrel and aspirin. Non-response to aspirin or clopidogrel is determined according to the result of the VerifyNow assay (cut off : < 15 % for P2Y12 and > 550 ARU for aspirin). The primary end point is the occurrence of definite or probable stent thrombosis (ARC definition) and the secondary end-points include global and cardio-vascular mortality, non fatal myocardial infarction and major bleeding. A clinical evaluation is scheduled at discharge and by telephone contact at one month and one year.

ReferenceCitation: Range G, Yayehd K, Belle L, Thuaire C, Richard P, Cazaux P, Barbou F, Koning R, Chassaing S, Teiger E, Berthier R, Decomis MP, Claudel JP, Delarche N, Brunel P, De Poli F, Dupouy P, Beygui F, Albert F, Collet JP, Montalescot G; VERIFRENCHY investigators. Thrombotic and bleeding events after coronary stenting according to clopidogrel and aspirin platelet reactivity: VerifyNow French Registry (VERIFRENCHY). Arch Cardiovasc Dis. 2014 Apr;107(4):225-35. doi: 10.1016/j.acvd.2014.03.004. Epub 2014 Apr 29.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Association Pour le Développement des Soins Cardiologiques de la ville de Chartres

collaborators:
Medtronic
Boston Scientific Corporation
Cordis Corporation
Abbott

location_facility: cardiology unit / Les hopitaux de Chartres


title: French Adult Primary Immune Thrombocytopenia: a pHarmacoepidemiological Study

acronym: FAITH

summary: Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.

lead_sponsor: University Hospital, Toulouse


title: Lower Limb Surveillance During VA-ECLS: Evaluation of Angiography Through the Reperfusion Cannula at VA-ECMO Implantation and of Near Infrared Spectroscopy (NIRS) Monitoring

summary: Temporary cardiac support by VA-ECLS can lead to lower limb ischemia. The aim of this study is to evaluate a multi-modal strategy (physical examination, NIRS monitoring and angiography through the reperfusion canula) of lower limb surveillance.

ReferenceCitation: Koszutski M, Mattei M, Maureira JP, Kimmoun A, Levy B. Assessment of bedside lower limb angiography combined with continuous NIRS monitoring for the detection of lower limb complications of VA-ECMO: an observational monocentric study. Crit Care. 2021 Jul 31;25(1):270. doi: 10.1186/s13054-021-03703-5.

publisher_dissemination: Springer-Nature

lead_sponsor: Central Hospital, Nancy, France


title: Usefulness of High Resolution Manometry in Constipation

acronym: MANOCOHR

summary: Constipation is a frequent symptom that is reported by more than 10% of the general population. In a few case, constipation is resistant to medical standard care, including osmotic and stimulant laxatives. The diagnosis of colonic inertia may be suspected in these patients although diagnostic criteria for colonic inertia may vary from one country to another. In France, the diagnosis of colonic inertia is based on manometric study of the colorectal contractile activity using manometric probe. Using conventional manometric catheters, severe alteration of the colorectal motility is found in a very small subset of patients, who may later benefit from surgery. The recent use of high resolution manometric probe allowed to map more precisely colorectal motility, but whether these new parameters are relevant remains to be assessed. The aim of this study is to assess the diagnostic performance of a new high resolution manometric probe by comparing healthy volunteers to patients suspected of colonic inertia.

lead_sponsor: University Hospital, Rouen