title: Obesity Clusters Using an Online Responsive-Design Platform: Intuitive Eating and Mental Health Key for Personalised Medicine

summary:
Objective: To determine clusters among weight-loss-seeking individuals for personalised obesity management and find questionnaires to help identify those who could benefit from psychological support.

Design: In a cross-sectional analysis using an online platform (Aviitam®), a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), a Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire.

Setting: An online weight management platform (Aviitam®) used by adults with obesity across France.

Participants: Adults with body mass index (BMI) >25 kg/m² participating in a weight management pathway who completed validated questionnaires assessing psychological and lifestyle factors.

Main Outcomes: Identification of clusters based on questionnaire responses, BMI, age and gender.

ipd_sharing_description: The data underlying this article will be shared on reasonable request to the corresponding author.


title: Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects

summary:
Infectious anorectitis is a poorly described clinical entity. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly made in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

The proctology center of the Marie Thérèse Center is the leading proctology center in the Ile-de-France region both in terms of recruitment and reputation, and drains a large proportion of patients with anorectitis for specialized care. The clinical microbiology laboratory of the Saint Joseph Hospital Group is linked to the Marie Thérèse Center to provide its expertise in the microbiological and infectious aspects of the management of these infections.

In recent years, the analysis of data from this large population of patients referred to the Léopold Bellan proctology center for suspected ano-rectitis has revealed the pathogens Neisseria gonorrhoeae and/or Chlamydia trachomatis.

Mycoplasma genitalium (MG) is an emerging pathogen responsible for Sexually Transmitted Infections (STI) and has been described increasingly in recent years. Studies on this pathogen will allow to better identify risk factors and to target optimized prevention and therapeutic management strategies.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Price MJ, Ades AE, De Angelis D, Welton NJ, Macleod J, Soldan K, Simms I, Turner K, Horner PJ. Risk of pelvic inflammatory disease following Chlamydia trachomatis infection: analysis of prospective studies with a multistate model. Am J Epidemiol. 2013 Aug 1;178(3):484-92. doi: 10.1093/aje/kws583. Epub 2013 Jun 27.

ReferenceCitation: Vieira VA, Avelino-Silva VI, Cerqueira NB, Costa DA, Costa PR, Vasconcelos RP, Madruga VR, Moreira RI, Hoagland B, Veloso VG, Grinsztejn B, Kallas EG; PrEP Brasil Study Team. Asymptomatic anorectal Chlamydia trachomatis and Neisseria gonorrhoeae infections are associated with systemic CD8+ T-cell activation. AIDS. 2017 Sep 24;31(15):2069-2076. doi: 10.1097/QAD.0000000000001580.

lead_sponsor: Fondation Hôpital Saint-Joseph

lead_sponsor_type: academique

status_simplified: Ongoing


title: Influence of Pneumonia on Delayed Cerebral Infarction After Subarachnoid Hemorrhage: a Retrospective Study

acronym: SAH-CIP

summary:
Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH.

Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI.

We plan to include between 200 and 250 patients in the analysis.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

status_simplified: Completed


title: Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)

acronym: DOLORES

summary:
Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation that when supported by the Mobile Services Emergency and Intensive Care (SMUR).

This ground of appeal underlying various pathologies especially acute coronary syndrome whose early care diagnostic and treatment significantly improves the prognosis.

The recognition and management of SCA is therefore a public health issue. Myocardial infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and coronary heart disease is the leading cause of death in France.

No studies have assessed the adequacy of regulation and management of chest pain SAMU for the diagnosis of SCA.

The main objective of the research is to have a descriptive analysis of the population controlled by the SAMU and the population served by the mobile emergency with chest pain. Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the final diagnosis and direction after passing emergency, cardiology and at follow-up to a year.

time_perspective: Prospective

ReferenceCitation: Bassand JP, Danchin N, Filippatos G, Gitt A, Hamm C, Silber S, Tubaro M, Weidinger F. Implementation of reperfusion therapy in acute myocardial infarction. A policy statement from the European Society of Cardiology. Eur Heart J. 2005 Dec;26(24):2733-41. doi: 10.1093/eurheartj/ehi673. Epub 2005 Nov 25.

ReferenceCitation: Karlson BW, Herlitz J, Pettersson P, Ekvall HE, Hjalmarson A. Patients admitted to the emergency room with symptoms indicative of acute myocardial infarction. J Intern Med. 1991 Sep;230(3):251-8. doi: 10.1111/j.1365-2796.1991.tb00439.x.

ReferenceCitation: Assez N, Adriansen C, Charpentier S, Baixas C, Ducasse JL, Goldstein P. [Management of acute coronary syndromes without ST elevation: the TOSCANE registry]. Arch Mal Coeur Vaiss. 2005 Nov;98(11):1123-9. French.

ReferenceCitation: Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, De Feyter PJ, Specchia G, Ruzyllo W; Task Force on the Management of Acute Coronary Syndromes of the European Society of Cardiology. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2002 Dec;23(23):1809-40. doi: 10.1053/euhj.2002.3385. No abstract available. Erratum In: Eur Heart J. 2003 Jun;24(12):1174-5. Eur Heart J. 2003 Mar;24(5):485.

ReferenceCitation: Sauval P, Bout H, Ohanessian A, Danchin N, Monsegu J, Varenne O, Carli P, Spaulding C. [Management of chest pain by the Emergency Ambulance Service: the DOLORES register]. Arch Mal Coeur Vaiss. 2005 Nov;98(11):1095-9. French.

ReferenceType: result

ReferenceCitation: Manzo-Silberman S, Assez N, Vivien B, Tazarourte K, Mokni T, Bounes V, Greffet A, Bataille V, Mulak G, Goldstein P, Ducasse JL, Spaulding C, Charpentier S. Management of non-traumatic chest pain by the French Emergency Medical System: Insights from the DOLORES registry. Arch Cardiovasc Dis. 2015 Mar;108(3):181-8. doi: 10.1016/j.acvd.2014.11.002. Epub 2015 Feb 7. Erratum In: Arch Cardiovasc Dis. 2015 May;108(5):333-4.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: French Cardiology Society

lead_sponsor_type: industriel


title: Characteristic of Drug Users Chronic Wound

acronym: TOXIPO

summary: The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .

ipd_sharing: Undecided

lead_sponsor: Central Hospital, Nancy, France


title: Lyon Clinical Research Program on Maternal and Congenital Toxoplasmosis Based on the Toxo-Ly Cohort: Risks and Clinical Consequences, Prevention, Diagnosis and Treatment

summary:
Several decades ago, France has made the choice to implement a national prevention program for congenital toxoplasmosis. The identification in their first trimester of pregnancy of all pregnant women who are susceptible to Toxoplasma infection has been mandatory since 1985. In 1992, the decision was made to extent the program to the monthly retesting of all women identified as not immune, in an attempt to reduce the number of severely infected children.

The systematic detection of all maternal and congenital infections has generated many questions from clinicians, biologists, parents and older patients, on the short and long-term prognosis of congenital toxoplasmosis, on the best tests to use to diagnose infections in mothers and children, on the efficacy of existing treatments, and on how to manage patients in the long-term.

The need to answer these many questions has prompted the medical team working within the laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse Hospital in Lyon to implement a clinical research program. It is based on the systematic inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children in order to confirm their infection or to rule it out. All congenitally infected subjects undergo clinical examinations, serological tests and ocular examination at least once a year without age limit.

The following data are prospectively collected in a dedicated database: gestational age at maternal infection and corresponding serological profile; type and dates of maternal treatment; findings of ultrasound tests and amniotic fluid analysis; serological and clinical findings at birth; types and dates of postnatal treatment; postnatal serological profiles; infection status at one year of age; long term clinical (ophthalmologic) et serological findings.

These data have allowed producing original findings on the risk of maternal-foetal transmission according to gestational age at maternal infection, on the long term ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the diagnosis, treatment and follow-up of maternal and congenital infections.

These efforts are still to be maintained in the future in order

to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the risk of ophthalmological events
to increase precision around our risk estimates for materno-foetal transmission,
to continue innovating in terms of diagnostic strategy to improve tests performances and reduce costs
to explore new potential clinical outcomes such as neuropsychiatric disorders associated with congenital and postnatal infection
to determine if infections due to oocysts could have different clinical outcomes than those due to the ingestion of cysts
to assess the efficacy of treatments for maternal and congenital infections

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

summary: This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

status: Enrolling by invitation

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

ipd_sharing: No

lead_sponsor: International Agency for Research on Cancer

location_facility: Regional Cancer Screening Coordinating Centre, Moselle Site

location_facility: Regional Cancer Screening Coordinating Centre, Ardennes site

location_facility: Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site

intervention_type: Other

status_simplified: Unknown


title: Impact of Exposure to Cosmetics on Sensitive Skin

acronym: SENSICOS

summary:
The concept of sensitive or reactive skin was evoked in 1947 and developed in the 1970s and is now widely recognized. The international pruritus society has proposed an international consensus definition: sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pruritus, tingling) in response to stimuli that normally do not not cause such sensations. The triggering factors can be cosmetics, water, cold, heat, temperature variations, wind ... etc.

The physiopathological mechanisms are debated and several hypotheses exist. Sensitive skin can be considered as a decrease of the threshold of cutaneous tolerance. Sensitive skin is linked to abnormalities of the cutaneous nervous system, which becomes hyper-reactive. This hyperreactivity can be modulated by multiple factors. Exposure to cosmetics could be one of the main triggers for sensitive skin, especially for women. This can be explained by the wide use of cosmetics (in France women apply an average of 16 different cosmetics per day), by overconsumption of cosmetics, by exposure to potentially irritating ingredients. Sensitive skin would be less tolerant to the frequent and prolonged use of cosmetics. However, no precise information is available on the actual consumption of cosmetic products in the population with sensitive skin, in particular no data exists concerning the type of products used, the criteria of choice of products, the daily number of products used. and the ingredients contained in these cosmetics

location_facility: Laboratory Interaction Neurons Keratinocytes


title: Feasibility Study of PD-L1 Expression Analysis on Circulating Tumor Cells by Immunocytochemistry and MDSCs Level Evolution Analysis in Non-small Cell Lung Cancer Treated With PD-L1 or PD1 Inhibitor

acronym: IMMUNO-PREDICT

summary:
Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.

Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs.

The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC

ReferenceCitation: Guibert N, Jones G, Beeler JF, Plagnol V, Morris C, Mourlanette J, Delaunay M, Keller L, Rouquette I, Favre G, Pradines A, Mazieres J. Targeted sequencing of plasma cell-free DNA to predict response to PD1 inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2019 Nov;137:1-6. doi: 10.1016/j.lungcan.2019.09.005. Epub 2019 Sep 6.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories_concat: HAL

ReferenceCitation: Guibert N, Pradines A, Favre G, Mazieres J. [Finding mutations of interest in circulating tumor DNA helps predict immunotherapy response in lung cancer]. Med Sci (Paris). 2020 May;36(5):437-439. doi: 10.1051/medsci/2020068. Epub 2020 May 26. No abstract available. French.

evidence: open (via free pdf)

license_normalized: no license

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

repository_institution: Chiba Institute of Technology - Springer Link

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: EDP Sciences

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


title: Interest of the Photographs by Smartphone During the Requests of Opinion Specialized in the Department of Dermatology of the CHRU of Nancy

acronym: PHOTODERM

summary: To study the diagnostic performance of the images on the smartphone compare the result of the clinical examination, all the dermatoses combined and by family of pathology (inflammatory, wound, oncology, infectious, allergology), during urgent request requests in dermatology

status: Unknown status


title: Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus

acronym: FLUVALENTINE

summary:
Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies.

The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus


title: Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation

acronym: REAL-GREFFE

summary: The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.

design_allocation: Non-Randomized

primary_purpose: Other


title: GenI: a Tool to Generate Paramedical Research Ideas

acronym: GenI

summary: In order to develop paramedical research culture, the paramedical staff need adapted tools and methods. The GenI project (Research ideas generation) has for main objective the design and validation of a tool that will allow the identification of paramedical research ideas. This tool will be built based on paramedical staff views. Our hypothesis is that the use of the GenI tool will help to detect research ideas in paramedical health care that could lead to research projects.


title: Study of the Remodeling of the Ascending Aorta During the Sports Season in Long Distance Triathletes Versus Controls

acronym: CoATri

summary: Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. In our preliminary work published in 2016, the investigators demonstrated in a small population of triathletes that there is also a vascular remodelling named athlete's artery. Moreover, the investigators know that left ventricle and aorta behave together like a couple. So they want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the cardiac AND aortic remodelling.

primary_purpose: Basic Science

ReferenceCitation: Dupont AC, Poussel M, Hossu G, Marie PY, Chenuel B, Felblinger J, Mandry D. Aortic compliance variation in long male distance triathletes: A new insight into the athlete's artery? J Sci Med Sport. 2017 Jun;20(6):539-542. doi: 10.1016/j.jsams.2016.10.009. Epub 2016 Oct 29.

intervention_type: Device


title: Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT

summary:
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.

The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.

study_start_date_type: Anticipated

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


title: Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy

summary:
Numerous patients are addressed to the Emergency Department for unspecific symptoms which can evoke a stroke, such as vertigo, isolated motor deficit, behavior disorder.

For these patients, when they arrive out of time for specific treatments such as thrombolysis and thrombectomy, the cerebral imagery is not an emergency, but necessary to confirm or invalidate the diagnostic of stroke.

If a biomarker could exclude the diagnostic of stroke, we could avoid an imagery for these patients.

PS100B is a biomarker whose blood level increases in case of stroke. It has already proven a prognostic value. Until now, it hasn't proven a diagnostic value because it take a few hours to increase in the blood.

It could have in prognostic value for patients who have the symptoms for more than 24 hours.

STROkE is a diagnostic, prospective, monocentric study, conducted at University Hospital Center of Poitiers (France).

The aim is to determine the value of PS100B to exclude the diagnostic of a stroke in case of evocative symptoms, for patients who are out of delay for a thrombolysis or a thrombectomy.

Patients eligible are the ones who present to the emergency department with symptoms evocative of stroke for more than 24 hours and less than 4 days. Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.

The diagnostic of stroke is than confirmed or excluded by an adjudication comity, who are unaware of the result of PS100B blood level.

The diagnostic value of PS100B is determined with the help of a ROC curve.

lead_sponsor: Poitiers University Hospital

location_facility:
C.H.U. de Poitiers
CHU Henri MONDOR


type: Registry Identifier

title: French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"

acronym: MATRIX

summary:
Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Progress has been made regarding the epidemiology of TMA (Bayer CJASN 2019). It has been shown that secondary TMAs account for 95% of cases, whereas primary TMAs (atypical hemolytic syndromes (HUS) and thrombotic thrombocytopenic purpura (TTP)) account for only about 5%.

However, in many cases, the pathophysiology, optimal management and prognosis of TMA remains unclear and it has been shown that patients with TMA may have renal-limited TMA or renal and hematological TMA (ie. With (mechanical anemia, thrombocytopenia, elevated LDH, decreased haptoglobin, schistocytes). In most studies, kidney biopsies are not performed and the diagnostic workup is uncomplete.

As this is a rare disease, only a multicenter approach (>20 centers) over a long period of time (>10 years), with adequate diagnostic workup including kidney biopsies can help us to answer these questions (investigators in the present are usually members of the CNR-MAT (a network of the TMA centers in France).

ReferenceCitation: Goodship TH, Cook HT, Fakhouri F, Fervenza FC, Fremeaux-Bacchi V, Kavanagh D, Nester CM, Noris M, Pickering MC, Rodriguez de Cordoba S, Roumenina LT, Sethi S, Smith RJ; Conference Participants. Atypical hemolytic uremic syndrome and C3 glomerulopathy: conclusions from a "Kidney Disease: Improving Global Outcomes" (KDIGO) Controversies Conference. Kidney Int. 2017 Mar;91(3):539-551. doi: 10.1016/j.kint.2016.10.005. Epub 2016 Dec 16.

ReferenceCitation: Bayer G, von Tokarski F, Thoreau B, Bauvois A, Barbet C, Cloarec S, Merieau E, Lachot S, Garot D, Bernard L, Gyan E, Perrotin F, Pouplard C, Maillot F, Gatault P, Sautenet B, Rusch E, Buchler M, Vigneau C, Fakhouri F, Halimi JM. Etiology and Outcomes of Thrombotic Microangiopathies. Clin J Am Soc Nephrol. 2019 Apr 5;14(4):557-566. doi: 10.2215/CJN.11470918. Epub 2019 Mar 12.

ReferenceCitation: Genest DS, Patriquin CJ, Licht C, John R, Reich HN. Renal Thrombotic Microangiopathy: A Review. Am J Kidney Dis. 2023 May;81(5):591-605. doi: 10.1053/j.ajkd.2022.10.014. Epub 2022 Dec 10.

lead_sponsor: University Hospital, Tours

location_facility: Department of Nephrology, University Hospital of Tours


title: Efficacy of Physical Therapy Using Cycling With vs With no Functional Electrical Stimulation in Patient With Severe Form of COVID-19: a Randomized Controlled Trial

acronym: FESrehabCoV

summary:
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the coronavirus disease 2019 (COVID-19) affect at late march 2021 more than 127 millions of persons worldwide (including more than 4.5 millions in France, according to John Hopkins University https://coronavirus.jhu.edu/map.html, consulted 2021/3/25). Among these persons, 17% of the confirmed cases the COVID-19 develop an acute respiratory distress syndrome (ARDS) (Chen et al., 2020), requiring an hospitalization in intensive care unit with mechanical ventilation for prolonged periods (in median up to 21 days whereas 3.3 is the usual mean length of stay). This prolonged period of inactivity causes dramatical muscles and cardio-respiratory losses. These patients experience a dramatical decrease in the physical ability which is reinforce by the protective isolation measures and containment to prevent the further spread of the virus.

Rehabilitation of patients with a severe form of the COVID-19 faced new challenges due to the novelty of the disease and protective isolation measures to prevent the further spread of the virus. Rehabilitation target a recovery of the cardio-respiratory, muscle deficits and improvement in activity. Functional electrical stimulation (FES) is one innovative technique, among other. FES have been shown as effective to improve the respiratory function in patients with a severe chronic obstructive pulmonary disease (Acheche et al., 2020; Maddocks et al., 2016), reduce the muscle loss due to zero gravity in space for astronauts (Maffiuletti et al., 2019), or increase strength in persons with incomplete spinal cord injury (de Freitas et al., 2018). FES has been recently delivered during cycling to restore pedaling movements with an adequate rhythm of muscle contraction. To date, FES cycling has been successfully administered in patients with spinal cord injury, and has been shown to be more effective in patient with severe COPD for improving the exercising intensity; reducing fatigue and improving quality of life in persons with multiple sclerosis (Backus et al., 2020).

In a pilot study, we shown that 4 week of physical therapy incluing FES cycling resulted in a fasten recovery of active postures as compared to physical therapy including cycling alone. (Mateo et al., under revision). Therefore, we hypothesize that a 4-week period of rehabilitation based on physical therapy with FES cycling would result in a significantly increase of activity profile (decrease in inactive posture duration) in patient with a severe form of COVID-19 (i.e., with an ARDS requiring mechanical ventilation).

primary_purpose: Treatment

intervention_type: Behavioral


type: Other Identifier

title: Feasability of Lung Ultrasonography in General Practice: A Multicentic, Observational and Descriptive Study

acronym: AmBulUs

summary:
A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation.

A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's.

Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization.

In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.

lead_sponsor: University Hospital, Caen


title: Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC

acronym: SPAC

summary:
SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy.

The aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.

The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria.

The hypothesis is that of a serum and peritoneal antibiotic under dosage.

ReferenceType: derived

ReferenceCitation: Leon L, Guerci P, Pape E, Thilly N, Luc A, Germain A, Butin-Druoton AL, Losser MR, Birckener J, Scala-Bertola J, Novy E. Serum and peritoneal exudate concentrations after high doses of beta-lactams in critically ill patients with severe intra-abdominal infections: an observational prospective study. J Antimicrob Chemother. 2020 Jan 1;75(1):156-161. doi: 10.1093/jac/dkz407.

oa_host_type: repository

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press


title: Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor

acronym: VIMBIL

summary:
Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200 implying that at least 300 000 peoples are concerned in France. Its frequency increase with age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can be associated with head/voice tremor. ET induces a social impairment but also difficulties to perform any task requiring dexterity. With time, tremor can be so severe that every activity of daily living is impaired with loss of autonomy.

Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed. However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery thalamotomy can be an alternative option.

Patients will be included with a minimum of 12 months after having the first thalamotomy (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in cognitive assessment, voice assessment and balance and postural assessment or neuroradiological abnormality.

Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation, voice assessment and balance and postural assessment.

The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will be done.

This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery thalamotomy in ET patients with severe impairment.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Impact of Complete Removable Prosthetic Rehabilitations Performed by an Innovative DDTENS Protocol, on the Quality of Masticatory Function and the Management of Completely Edentulous Patients

acronym: DD-TENS

summary:
Total edentulism is a profound physical, psychic and social handicap, which affects 5 million people in France. The most frequent complaint of edentulous patients rehabilitated by conventional Complete Removable Prostheses (CRP) is the reduction of masticatory efficiency. This alteration has medical repercussions and a negative psychological and social impact.

Our study aims to evaluate the impact of an innovative protocol on the quality of masticatory function, prosthetic treatment and, in fact, on the quality of life of the totally edentulous patient. This protocol combines the Digital Denture system with the transcutaneous electrical neurostimulation system (TENS®), in order to improve the balance of the dento-dental contacts of CRP. This new protocol is called DDTENS.

The first objective of the study is to compare the activity and balance of the masticatory muscles at 1 month (T1) of wearing the prostheses, between an experimental group benefiting from a CRP by the DDTENS protocol and 2 reference groups ( the first benefiting from a CRP by the conventional procedure and the second by the Digital Denture procedure) in bimaxillary total edentulous patients

The secondary objectives are:

to compare the number of sessions required to obtain a finalized bimaxillary total removable prosthesis between the 3 groups.
to compare the quality of life of patients with their CRP between the 3 groups, at 1 month and 4 months of wearing the prostheses.
to compare the activity and balance of the masticatory muscles when the prostheses were put in the mouth (T0) and at 4 months (T4) of wearing the prostheses

The study design is a randomised open-label controlled pilot study with blinded reviewer assessment comparing 3 parallel groups:

Experimental group: 10 bimaxillary edentulous patients rehabilitated by CRP using the DDTENS protocol.
Control group 1: 10 edentulous bimaxillary patients rehabilitated by CRP according to the conventional method (gold standard technique).
Control group 2: 10 edentulous bimaxillary patients rehabilitated by CRP using the Digital Denture procedure.

The expected benefits for patients in the DDTENS experimental group are the optimization of occlusal balance, the optimization of the time of integration of the prosthesis in the mouth, the time saving in the prosthetic treatment of the edentulous patient and the improvement of eating behaviours and quality of life of edentulous patients which would delay the entry of our patients into the sphere of dependence.

These results would allow the validation of a new rehabilitation protocol for the edentulous patient, leading to a modification of clinical practices.

lead_sponsor: University Hospital, Montpellier


title: Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities

acronym: ZOMETA

summary:
The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

Description of child population with osteoporosis in the context of motor impairment in Lorraine region
Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
Description of current osteoporosis preventive care
Description of risk factors associated to bone status (drugs)
Evaluation of zoledronic acid treatment on fracture numbers
Evaluation of zoledronic acid on phosphocalcic profile
Description of side effects of zoledronic acid in this indication
Description of treatment effects in the sub-population of children with Rett syndrome.

intervention_type: Drug


title: Touching the World With a (Blind) Cane: Cognitive and Neural Processes

summary: The use of tools is ubiquitous in our lives and allows us to expand the sensorimotor capacities of our body. Much research has been done on the subject in sighted people over the past decades. This work has mainly focused on the motor aspect of using the tool, neglecting the sensory aspect. However, any action involving a tool carries sensory information, for example in the use of the white cane by blind people. 26% (> 200,000) of blind people in France use a white cane to get around. By sweeping the cane on the ground, they use it as a sensorimotor extension of their body to extract information from the environment in order to locate a pedestrian crossing or possible obstacles. While it is well established that the tools increase the user's motor skills, we have only just begun to clarify how they also function as sensory extensions of the user's body and how this phenomenon is potentially dependent on constant use of the tool to compensate for a missing sense, as is the case with blind people using a cane. The aim of this study is to fill this important gap in our knowledge.


title: Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.

acronym: ChroCéRAAC

summary:
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.

The ERAS has been scientifically validated and standardized in many surgical disciplines since the implementation of guidelines in France in 2016.

Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.

Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.

But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.

Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.

It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.

Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.

In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.

To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.

This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.

ReferenceCitation: Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments

summary:
Healthcare renunciation is defined as: "Individuals give up care when they do not seek services and health care professionals when they experience a disorder, experience a physical or mental disorder, or when they do not access all of the prescribed care." In 2008, 16.5% of the general French population reported having renounced care. The causes mentioned of the renunciation are mainly the financial difficulties, the deadlines of appointments considered too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of care is estimated at 27.6% over the period from 2014 to 2017.

In the context of the COVID-19 epidemic, containment was applied in France counted from 17 March 2020. The widespread message was "save lives, stay at home". The Ministry of Solidarity and Health has provided health professionals with a circular to adapt the management of patients with chronic disease, requiring elective surgical care and pregnant women.

The decline in activity of general practitioners is estimated at 44% and that of other specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for children.

The main risk is the deterioration of the health status of some patients with the worsening of chronic diseases, the discovery of pathologies during episodes of decompensation and the absence of management of serious acute pathologies.

The study aims to assess the importance of giving up care during this period of COVID-19 and in comparison with a study conducted at the University Hospital of Angers and the hospital of Le Mans in 2017.

lead_sponsor: University Hospital, Angers

location_facility:
CH Le Mans
CHU Angers


title: Incidence, Risk Factors and Impact on Renal Function of the Appearance of Crystalluria Under High-dose Intravenous Amoxicillin

acronym: CRISTAMOX

summary:
Intravenous high-dose amoxicillin is a frequently prescribed antibiotic in intensive care units and infectious disease departments, in such indications as meningitis, endocarditis, listeriosis, or documented susceptible osteo-articular infections.

Among possible side effects is the occurrence of amoxicillin crystalluria. Its incidence is unknown. It is deemed uncommon but literature is poor and its incidence is probably under-estimated. It can be complicated with hematuria or acute renal failure and may require renal replacement therapy. measures that can limit the impact of this nephrology crystalluria.

Since the beginning of 2014, because of the occurrence of a case of macroscopic crystalluria in our unit and a pharmacovigilance alert, it has been decided to search systematically for amoxicillin crystalluria in several centers of the north-east of France. The investigators propose to study these patients, through an observational study of a multicenter longitudinal cohort, to assess the incidence of amoxicillin crystalluria during high dose intravenous amoxicillin treatment.

ReferenceCitation: Demotier S, Limelette A, Charmillon A, Baux E, Parent X, Mestrallet S, Pavel S, Servettaz A, Drame M, Muggeo A, Wynckel A, Gozalo C, Taam MA, Fillion A, Jaussaud R, Trenque T, Piroth L, Bani-Sadr F, Hentzien M; CRISTAMOX Study group. Incidence, associated factors, and effect on renal function of amoxicillin crystalluria in patients receiving high doses of intravenous amoxicillin (The CRISTAMOX Study): A cohort study. EClinicalMedicine. 2022 Mar 12;45:101340. doi: 10.1016/j.eclinm.2022.101340. eCollection 2022 Mar.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: CHU de Reims


type: EudraCT Number

title: Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial

acronym: CLICA

summary:
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.

In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.

Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Procedure


title: Development of a Predictive Algorithm for the Risk of Rehospitalization of Patients With Heart Failure

summary:
Heart failure is a chronic disease whose prevalence, due to the aging of the population, is increasing. In France, the prevalence of this pathology is 2.3% (it reaches 10% in the over 75 years) and affects nearly a million patients.

The rehospitalization of patients with heart failure affects 25% of patients within 1-3 months of hospital discharge, and 66% at 1 year while 75% of hospitalizations are preventable. These readmissions result in decreased quality of life and increased mortality; from an economic point of view, hospitalization accounts for 70% of expenses related to the management of heart failure. Avoiding rehospitalization is therefore a major public health issue. The current predictive scores remain perfectible, even though risk factors for readmission have already been the subject of numerous studies. The identification of patients at risk of rehospitalization is still an issue, especially for patients with preserved left ventricular ejection fraction. Targeting patients requiring appropriate care remains an issue.

The rise of innovative statistical techniques around Big Data in health opens new perspectives for the scientific exploitation of data available in electronic medical records, for example in the field of prediction. This study aims to explore the risk of rehospitalization in heart failure patients by analyzing routine data collected in medical records and by mobilizing artificial intelligence algorithms. A review of the literature confirms the innovative nature of such an approach: the majority of the studies identified implemented a prospective collection of data; only 20% of the studies mobilized the medical file; no French study used the new machine learning algorithms.


title: Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage

acronym: PEACH

summary:
Haemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48 hours). Currently, no urgent medical or surgical treatment has been shown to improve functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 % to 40 %).

Some studies have suggested that early repeated epileptic seizures may be associated with a worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain tissue. Thus, prevention of early epileptic seizures may improve neurological outcome. However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and subclinical epileptic seizures has not been evaluated in the setting of intracerebral haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only when epileptic seizures occur.

Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter EEG.

Secondary Objectives:This study also aims to assess:

Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months) clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the admission brain CT scan with the control CT scan performed at 72 hours, on the neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and 3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12 months.

Ä The frequency of side effects related to treatment with levetiracetam (anxiety and depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample Size: 104 patients will be recruited over 2 years.

ReferenceCitation: Peter-Derex L, Philippeau F, Garnier P, Andre-Obadia N, Boulogne S, Catenoix H, Convers P, Mazzola L, Gouttard M, Esteban M, Fontaine J, Mechtouff L, Ong E, Cho TH, Nighoghossian N, Perreton N, Termoz A, Haesebaert J, Schott AM, Rabilloud M, Pivot C, Dhelens C, Filip A, Berthezene Y, Rheims S, Boutitie F, Derex L. Safety and efficacy of prophylactic levetiracetam for prevention of epileptic seizures in the acute phase of intracerebral haemorrhage (PEACH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2022 Sep;21(9):781-791. doi: 10.1016/S1474-4422(22)00235-6.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_facility: Department of functional neurology and epileptology


title: French Colorectal ESD Cohort in Experts Centers

acronym: FECCo

summary:
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

time_perspective: Other

ReferenceCitation: Patenotte A, Yzet C, Wallenhorst T, Subtil F, Leblanc S, Schaefer M, Walter T, Lambin T, Fenouil T, Lafeuille P, Chevaux JB, Legros R, Rostain F, Rivory J, Jacques J, Lepilliez V, Pioche M. Diagnostic endoscopic submucosal dissection for colorectal lesions with suspected deep invasion. Endoscopy. 2023 Feb;55(2):192-197. doi: 10.1055/a-1866-8080. Epub 2022 Jun 1.

oa_host_type: closed

publisher_dissemination: Georg Thieme

lead_sponsor: University Hospital, Limoges


title: Impact of Confinement and Preventive Measures in Period of SARS-COV2 Infection on Clinical Features, Diagnostic and Therapeutic Management and Prognosis of Patients With Lung Cancer: an Ambispective Study Extended Over 2 Time Periods.

acronym: CBP-COVID

summary:
The unexpected onset of SARS-COV2 infection modified our practices, especially in routine medicine. In order to reverse the epidemic curve of severe cases and slow the spread of the infection, confinement was generalized in France from March 13, 2020.These restrictive measures were imposed on anyone with symptoms compatible with the infection, with the exception of dyspnea and other criteria of severity. March 12, 2020 is the pivotal date when the management of COVID came to interfere with medical and healthcare organizations. From this date, it is likely that some imaging or endoscopic exams have been de-scheduled for symptoms that are sometimes wrongly judged to be non-urgent and have seen their numbers drop dramatically.Otherwise, concerning lung cancer, preventive measures have been extremely strengthened. For instance, it is recommended to delay surgeries for localized tumors, to relieve or remove some chemotherapy or to delete radiotherapy sessions deemed non-essential. However, symptoms that may initially be attributed to viral infection, such as cough, fever, fatigue, or chest pain may be clinical indicators of early-stage Lung cancer. In addition, lung cancer is likely to make the patient more susceptible to pneumopathy, due to a weakened of immune response to viruses and bacteria. Consequently, as necessary as the restriction measures are, a risk of slowing down in the management of the Lung cancer pathology exists.

The CBP-COVID Study intends to assess consequences of restrictive measures linked to the SARS-COV2 epidemic, by comparing clinical characteristics at diagnosis, treatment times and treatments, regarding to 2 distinct time periods identical to the calendar, but one in 2019, the other in 2020.

lead_sponsor: Centre Hospitalier le Mans

sponsor_collaborators:
Centre Hospitalier le Mans
ONCO PAYS de la LOIRE


title: Contribution of Muscle and Disc Elastography in the Evaluation of Biomechanical Modifications of the Neuromuscular Spine Fixed by Bipolar Construct

acronym: ELASTO

summary:
Neuromuscular scoliosis are caused by a disorder of the brain, spinal cord or muscular system and often progressive at early age. Conservative treatment is not sufficient to maintain trunk and pelvic balance, and surgical treatment is frequently required. Early definitive spine fusion has the disadvantage of cessation of trunk growth with concomitant effects on lung development. Growth preserving spine surgeries are increasingly used but with high complication rates.

The orthopaedic team at Necker Hospital Enfants maladies, Paris, France has developed an innovative fusionless surgery based on a bipolar spine construct, performed by a minimally invasive approach. The first 100 patients operated on with this technique had an average follow-up of 6.5 years. No arthrodesis, initially planned in adolescence, was necessary thanks to the stability of the correction of the deformities even after skeletal maturation.

The main objective of the study was to analyze the progressive spinal stiffening, using muscle and disc elastography, in neuromuscular patients instrumented with this bipolar construct.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: The Effectiveness of Ultrasound-guided Technique Compared to Blind Technique in Medial Brachial Cutaneous Nerve Block and Intercostobrachial Nerve Block, in the Axilla

summary: The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. The anesthesia of the posterior and the medial side of the arm requires a selective block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to achieve this block : the blind technique (without ultrasound) and the ultrasound-guided technique. At the moment, there are no studies which compare these two techniques. So, the purpose of this study is to determine the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial nerve block, in the axilla.

primary_purpose: Supportive Care

ReferenceCitation: Magazzeni P, Jochum D, Iohom G, Mekler G, Albuisson E, Bouaziz H. Ultrasound-Guided Selective Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves: A Randomized Clinical Trial. Reg Anesth Pain Med. 2018 Nov;43(8):832-837. doi: 10.1097/AAP.0000000000000823.

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

repository_institution: Open Research Library - BiblioBoard Library Catalog

publisher_dissemination: British Medical Journal


title: Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure

acronym: PREMEDIC

summary:
The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart Failure will be enrolled and health data will be collected at hospital admission and during hospital stay. No data will be collected before detailed information is given to the patient and a non-opposition is obtained.

The aim of this observational and prospective study is to evaluate the concordance actual patient management during the in hospital treatment of heart failure and the therapeutic proposals from a medical algorithmic decision support software.


title: Impact of a Program to Prevent the Risk of Antisocial Behavior and Attacks of Patients or Attendant on Healthcare Workers in an Ophthalmic Emergency Unit.

acronym: PREVURGO

summary:
At the hospital, the attacks against health professionals are becoming commonplace, making working conditions difficult. The ophthalmological emergencies are a perfect testing ground to evaluate the effectiveness of a series of original actions to prevent the occurrence of violence against healthcare workers. The main objective is to measure the impact of an integrated prevention of the occurrence of antisocial behavior or attacks against the healthcare workers.

The prevention program combines five interventions (steps): 1) a computer sorting algorithm and specific screens for calling patients in waiting rooms, 2) a clear signage to direct patients between waiting rooms, treatment rooms and administrative et medical offices, 3) Posts information on the activity of emergency services displayed on screens, in the waiting rooms, 4) a mediator/go-between/conciliator, 5) and a dummy surveillance camera.

This is an interrupted time series study. All patients admitted to the ophthalmological emergency unit of a university hospital located in Lyon, France, are included in the study, from June 2013 to Sept 2015

ReferenceCitation: Touzet S, Occelli P, Denis A, Cornut PL, Fassier JB, Le Pogam MA, Duclos A, Burillon C. Impact of a comprehensive prevention programme aimed at reducing incivility and verbal violence against healthcare workers in a French ophthalmic emergency department: an interrupted time-series study. BMJ Open. 2019 Sep 5;9(9):e031054. doi: 10.1136/bmjopen-2019-031054.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Université de Lausanne - SERVAL

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

repositories:
HAL
PubMed Central
serval.unil.ch

repositories_concat: HAL;PubMed Central;serval.unil.ch

unpaywall_oa_status: gold

ReferenceCitation: Touzet S, Cornut PL, Fassier JB, Le Pogam MA, Burillon C, Duclos A. Impact of a program to prevent incivility towards and assault of healthcare staff in an ophtalmological emergency unit: study protocol for the PREVURGO On/Off trial. BMC Health Serv Res. 2014 May 19;14:221. doi: 10.1186/1472-6963-14-221.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Springer

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot


title: Precise Recognition With Enhanced Vision of Endocrine Neck Targets

acronym: PREVENT

summary:
Iatrogenic injuries to the parathyroid glands during thyroid surgery or to the recurrent laryngeal nerve (RLN) do still occur, requiring often specialized management.

Recently, it has been demonstrated that the parathyroid gland shows a significant autofluorescence. Using a commercially available Near-InfraRed (NIR) camera (Fluobeam®, Fluoptics©, France), the parathyroid glands can be clearly visualized by contrast-free fluorescence imaging. However it lacks real-time quantification of the fluorescence intensity.

The hyperspectral imaging (HSI), which is a technology that combines a spectrometer to a camera system, examines the optical properties of a large area in a wavelength range from NIR to visual light (VIS). It provides spatial information real time, in a contact-free, non-ionizing manner. The HSI technology would add the spatial information, thus enormously enhancing the intraoperative performance.

The aim of the proposed study is to identify the spectral features of the important neck target structures, in particular the parathyroid glands, using an appropriate deep learning algorithm, to perform an automated parathyroid recognition. Additionally, this study proposes to compare the detection rate of the hyperspectral based parathyroid recognition with the already existing NIR autofluorescence based recognition.

ReferenceCitation: Mohebati A, Shaha AR. Anatomy of thyroid and parathyroid glands and neurovascular relations. Clin Anat. 2012 Jan;25(1):19-31. doi: 10.1002/ca.21220. Epub 2011 Jul 28.

ReferenceCitation: Christou N, Mathonnet M. Complications after total thyroidectomy. J Visc Surg. 2013 Sep;150(4):249-56. doi: 10.1016/j.jviscsurg.2013.04.003. Epub 2013 Jun 6.

ReferenceCitation: Nair CG, Babu MJ, Menon R, Jacob P. Hypocalcaemia following total thyroidectomy: An analysis of 806 patients. Indian J Endocrinol Metab. 2013 Mar;17(2):298-303. doi: 10.4103/2230-8210.109718.

ReferenceCitation: Yazici P, Bozkurt E, Citgez B, Kaya C, Mihmanli M, Uludag M. Incidental parathyroidectomy as a cause of postoperative hypocalcemia after thyroid surgery: reality or illusion? Minerva Chir. 2014 Dec;69(6):315-320. Epub 2014 Sep 22.

ReferenceCitation: Berber E, Parikh RT, Ballem N, Garner CN, Milas M, Siperstein AE. Factors contributing to negative parathyroid localization: an analysis of 1000 patients. Surgery. 2008 Jul;144(1):74-9. doi: 10.1016/j.surg.2008.03.019. Epub 2008 May 21.

ReferenceCitation: Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.

ReferenceCitation: Falco J, Dip F, Quadri P, de la Fuente M, Rosenthal R. Cutting Edge in Thyroid Surgery: Autofluorescence of Parathyroid Glands. J Am Coll Surg. 2016 Aug;223(2):374-80. doi: 10.1016/j.jamcollsurg.2016.04.049. Epub 2016 May 20.

ReferenceCitation: Li Q, He X, Wang Y, Liu H, Xu D, Guo F. Review of spectral imaging technology in biomedical engineering: achievements and challenges. J Biomed Opt. 2013 Oct;18(10):100901. doi: 10.1117/1.JBO.18.10.100901.

ReferenceCitation: Lu G, Fei B. Medical hyperspectral imaging: a review. J Biomed Opt. 2014 Jan;19(1):10901. doi: 10.1117/1.JBO.19.1.010901.

ReferenceCitation: Siddiqi AM, Li H, Faruque F, Williams W, Lai K, Hughson M, Bigler S, Beach J, Johnson W. Use of hyperspectral imaging to distinguish normal, precancerous, and cancerous cells. Cancer. 2008 Feb 25;114(1):13-21. doi: 10.1002/cncr.23286.

ReferenceCitation: Panasyuk SV, Yang S, Faller DV, Ngo D, Lew RA, Freeman JE, Rogers AE. Medical hyperspectral imaging to facilitate residual tumor identification during surgery. Cancer Biol Ther. 2007 Mar;6(3):439-46. doi: 10.4161/cbt.6.3.4018. Epub 2007 Mar 16.

ReferenceCitation: Kumashiro R, Konishi K, Chiba T, Akahoshi T, Nakamura S, Murata M, Tomikawa M, Matsumoto T, Maehara Y, Hashizume M. Integrated Endoscopic System Based on Optical Imaging and Hyperspectral Data Analysis for Colorectal Cancer Detection. Anticancer Res. 2016 Aug;36(8):3925-32.

ReferenceCitation: Fabelo H, Ortega S, Ravi D, Kiran BR, Sosa C, Bulters D, Callico GM, Bulstrode H, Szolna A, Pineiro JF, Kabwama S, Madronal D, Lazcano R, J-O'Shanahan A, Bisshopp S, Hernandez M, Baez A, Yang GZ, Stanciulescu B, Salvador R, Juarez E, Sarmiento R. Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations. PLoS One. 2018 Mar 19;13(3):e0193721. doi: 10.1371/journal.pone.0193721. eCollection 2018.

ReferenceCitation: Sumpio BJ, Citoni G, Chin JA, Sumpio BE. Use of hyperspectral imaging to assess endothelial dysfunction in peripheral arterial disease. J Vasc Surg. 2016 Oct;64(4):1066-73. doi: 10.1016/j.jvs.2016.03.463. Epub 2016 Jun 4.

ReferenceCitation: Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.

ReferenceCitation: Yudovsky D, Nouvong A, Pilon L. Hyperspectral imaging in diabetic foot wound care. J Diabetes Sci Technol. 2010 Sep 1;4(5):1099-113. doi: 10.1177/193229681000400508.

ReferenceCitation: Yudovsky D, Nouvong A, Schomacker K, Pilon L. Monitoring temporal development and healing of diabetic foot ulceration using hyperspectral imaging. J Biophotonics. 2011 Aug;4(7-8):565-76. doi: 10.1002/jbio.201000117. Epub 2011 Apr 1.

ReferenceCitation: Schols RM, Alic L, Wieringa FP, Bouvy ND, Stassen LP. Towards automated spectroscopic tissue classification in thyroid and parathyroid surgery. Int J Med Robot. 2017 Mar;13(1). doi: 10.1002/rcs.1748. Epub 2016 May 19.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Performance of Pelvic Radiograph, CT -Scan and MRI of the Sacroiliac Joints to Diagnose Structural Sacroiliitis in a Large Cohort of Patients With Suspicion of Spondyloarthritis

acronym: Passerelle

summary: The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and 2° to quantify structural elementary lesions on MRI and for the first time on CT-scan according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis (ECHOSpA).

lead_sponsor: Central Hospital, Nancy, France

sponsor_collaborators:
Central Hospital, Nancy, France
Pfizer


title: Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery

summary: Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery

status: Withdrawn

lead_sponsor: Biom'Up France SAS


title: Effect of the Consumption of Yogurt Fortified in Calcium and Vitamin D on the Circulating Levels of 25OHD in Postmenopausal Women

summary: The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the serum concentration of 25-hydroxy vitamin D (25OHD) (D2 + D3) in postmenopausal women.

lead_sponsor: Yoplait France SAS

sponsor_collaborators:
Yoplait France SAS
Eurofins Optimed

intervention_type: Dietary Supplement


title: Single Center, Randomized, Comparative, Prospective Interventional Study Evaluating the Impact of Brief Psychotherapy by Narrative Exposure Therapy (NET) on the Reduction of Symptoms of Post Traumatic Stress Disorder in Refugee and Asylum Seeking Women in the Program SINDIANE in Marseille

acronym: SINDIANE

summary: Displaced people, like refugees or asylum seekers, have high rate of potentially traumatic events. PTSD is one of the most common psychiatric trouble in this population. It requires specialized support and psychosocial program. Narrative Exposure Therapy (NET), a german psychotherapy, was developed in the 2000 to specifically treat psycho-trauma in this population. It is brief, effective on complex trauma and can be delivered by trained non-caregivers. All published randomized studies have conclued that NET is effetive, but there are still insifficient numbers to make recomendations. To our knowledge, NET has never been tested in France. In Marseille, SINDIANE is a community support and program for refugees and asylum seekers. Many workshops led by peer workers are offered to increase empowerment of beneficiaries and hel them to recover. The development of a NET workshop would make it possible to combine community support and specific and validated psychotherapy. Through this study, the investigators hypothesize that tratment of PTSD with NET in the community-based SINDIANE program decrease symptoms of PTSD.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units PREVENIR Study.

acronym: PREVENIR

summary: The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.

ReferenceCitation: Lesny M, Conrad M, Latarche C, Sylvestre A, Gaujard E, Dubois V, Quignard C, Citro V, Thomas JC, Bridey C, Weber AM, Simon C, Klein S, Gibot S, Bollaert PE. Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. Intensive Crit Care Nurs. 2020 Oct;60:102881. doi: 10.1016/j.iccn.2020.102881. Epub 2020 Jun 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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


title: Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia

acronym: EQUIDYS

summary:
The purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children.

The secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia.

location_facility: Centre de Référence pour les Troubles des Apprentissages - Hôpital d'Enfants - CHU de Nancy


title: Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients

acronym: REUNIE

summary:
The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.

Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

location_facility: Service de Neurologie, Hôpital Central, CHRU de Nancy


title: Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis

acronym: SALBUTAMOL

summary:
The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.

This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.

location_facility: CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques


title: Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

acronym: FNa-CHOLINE

summary:
The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases.

Secondary purposes are:

To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment
To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions)
To evaluate the inter-judge concordance of interpretation of sodium fluoride PET
To study the discordance of metastatic status of 2 techniques.

location_facility: Service de Médecine Nucléaire CHRU de Nancy-Brabois


title: Analysis of Soluble TREM (Triggering Receptor Expressed on Myeloid Cells)-1 and -2 in Crevicular Fluid and Associated Bacterial Flora in Patients Affected by Periodontitis

acronym: TREM

summary:
Etiopathology of periodontitis is complex and various risk factors are known :

Bacterial factors: major risk factor. Although the presence of periodontopathogen bacteria is necessary for the onset of periodontitis, these microorganisms are not sufficient for progression of all periodontal disease.
Immune factor: host immune response modulates the disease evolution to destruction or recovery. The most studied cytokine in periodontology is IL-1 that induces various immune reactions and bone resorption directly or indirectly through the stimulation of prostaglandin E2 (PGE2) release. PGE2 activates the matrix metalloproteinases that are responsible of the degradation of bone extracellular matrix.

Cytokine production, especially TNFα, IL-1β, IL-6 and IL-8, by some immune cells is modulated by new identified molecules such as Triggering Receptor Expressed on Myeloid cells (TREM) whose role in periodontitis is unknown.

The purpose of this study is to compare concentrations of soluble TREM-1 and TREM-2 markers in infected sites and in healthy sites in patients affected by periodontitis.

Other purposes are

Comparison of soluble TREM-1 and TREM-2 concentrations in healthy sites in patients affected by periodontitis and in healthy patients
Comparison of soluble TREM-1 and TREM-2 concentrations before and after etiologic periodontitis treatment
Estimation of the correlation between soluble TREM-1 and TREM-2 concentrations and clinical signs of periodontitis
Description of soluble TREM-1/TREM-2 ratio before and after etiologic treatment
Description of presence of some bacteria in sites analyzed for soluble TREM-1 and TREM-2
Search for the most observed bacteria in presence of high concentrations of soluble TREM-1 and TREM-2 before and after etiologic treatment
Evaluation of the impact of psychological stress measured through salivary cortisol level in saliva on TREM-1 and -2 expression
Evaluation of the impact of psychological stress through stress and anxiety auto-questionnaires (Spielberger and Cohen) on soluble TREM-1 and TREM-2 concentrations in crevicular fluid of healthy and pathologic teeth.

location_facility: Service Odontologie - Site Heydenreich - CHRU Nancy


title: Influence of Patient Position on Attenuation Artifacts Observed in D-SPECT Camera Myocardial Tomoscintigraphy

acronym: D-SPECT BIKER

summary:
The purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.

The hypothesis is that the percentage of myocardial segments with attenuation is significantly lower when acquisitions are made in forward tilted position (biker position).

The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to attenuation artifacts (anterior, apical and inferobasal regions).

location_facility: Service de Médecine Nucléaire - CHRU de Nancy-Brabois


title: Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Patients Affected by Spondyloarthritis

acronym: FNa

summary:
The purpose is to compare detection of axial inflammatory lesions in patients affected by spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic resonance imaging (MRI), the reference technique.

It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of patients with early forms of spondyloarthritis.

Secondary purposes are:

To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage (except spine and sacroiliac joints)
To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and compare these data to clinic-biologic parameters used in clinical practice (BASDAI, BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural evaluation (sacroiliac New York, mSASSS and BASRI scoring methods)
To study correlation of axial and peripheral bone inflammation (spine and sacroiliac joints) evaluated with sodium fluoride PET with biologic markers of inflammation and bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α).

Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI. It is interesting to compare to activity obtained with PET. Moreover, it has been recently showed the disassociation of inflammation and structural progression (anti-TNF treatments do not prevent structural progression) that is associated to markers of bone remodeling whose activity is influenced by an activation/inhibition system of biologic markers of inflammation.


title: Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study

acronym: Oba

summary:
The purpose of this study is to compare average methylation of epigenetic markers on genomic DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:

Of obese young adults and healthy young adults
Of obese young adults and individuals affected by Alzheimer's disease (AD) having been obese at young adult age (<50 years old) or individuals affected by Alzheimer's disease (AD) having never been obese.

The secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults.


title: Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust

acronym: ADK-FO

summary: Nasal adenocarcinomas are closely related to wood dust exposure. The precise mechanisms of carcinogenesis leading to the transformation of the respiratory mucosa into a colonic-like mucosa remain unknown: chronic exposure to wood dust may cause chronic inflammation that may lead to pre-degenerative lesions, hypothesis yet unconfirmed. The tumor development requires the activation of a particular gene: CDX2. The working hypothesis is that chronic wood dust exposure is responsible for changes in genes of inflammation, which can in turn lead to changes in the expression of CDX2 and its cofactors, thus making possible the genesis of adenocarcinoma. This work is a pilot study aiming to better understand the mechanisms of carcinogenesis, and to study the feasibility of a larger prospective screening for woodworkers adenocarcinomas. Cells will be obtained from the at risk area (olfactory cleft) by a noninvasive method (brushing) in healthy volunteers (unexposed to wood dust) and in exposed volunteers to compare their genomes and study the genomic changes related to wood dust exposure.


title: ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

acronym: ARDStrain

summary: Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.

ReferenceCitation: Lemarie J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.

publisher_dissemination: Springer-Nature


title: Hemoglobin Monitoring During High Bleeding Risk Surgery in Pediatric Patients: Equivalence Study of Hemoglobin Transcutaneous Saturation and Hemocue With Total Serum Hemoglobin

acronym: Hemoped

summary: Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels


title: Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After Hemorrhoidal Artery Ligation (HAL)

acronym: HALTY

summary:
The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, via a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles) components. The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It has been popularized in France by some authors.

lead_sponsor: University Hospital, Grenoble


title: Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse: Single-center, Randomized, Controlled, Blinded Pilot Study

summary:
Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%.

Brain imaging research shows that the dorsolateral prefrontal cortex (DLPFC) is involved in tobacco addiction. Disorders induced in the CPFDL cause an irrepressible desire to smoke (craving) and explain a large part of the relapse at the time of smoking cessation.

Transcranial magnetic stimulation (TMS) could be promising in smoking cessation. This technique allows direct stimulation of the DLPFC via a magnetic coil, so as to reduce the cortical activity of the DLPFC, and thus reduce tobacco craving.

A first randomized controlled study was conducted at the Dijon University Hospital in Dijon in smokers who were heavily addicted and who had failed with the usual withdrawal strategies. In this study, it was found that the combination of nicotine substitutes (to reduce the physical symptoms of withdrawal) with 10 sessions of TCS (to reduce craving) made it possible to maintain abstinence from tobacco during the first 2 weeks of withdrawal (% abstinence = 88.8% active TCS group vs. 50% placebo TCS group; p=0.027).

However, in this study, the therapeutic effect of the nicotine-TCS combination was not prolonged once the stimuli stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different.

It is therefore proposed to renew the protocol by adding maintenance brain stimulation to the initial protocol. Used in the treatment of depression, the maintenance brain stimuli could increase the chances of smoking cessation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation and Characterization of Motion Sickness on Passengers Sailing on the Astrolabe

acronym: SICKVEST

summary: Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions Astrolabe, sometimes there is a risk of very significant dehydration. A special unit specialized in the fundamental study of the vestibular system (inner ear), sensory organ at the base of visual-vestibular conflict inducing this syndrome, also provides medical support for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly present. The goal of the study is to assess the frequency of occurrence of this sea sickness syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality traits, anxiety / stress) without changing habits on board for those on board taking a antinaupathique treatment given by the ship's doctor. This study will be done in collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER specialized in extreme environments (Belgium). The ultimate goal will be to provide the best recommendations and the best treatment regimen to alleviate as best as possible the symptoms of people on board of the Astrolabe so scientists on board can perform their work.


title: Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient: Influence on the Implementation of an Arteriovenous Fistula Prior to Dialysis and on Access to Renal Transplantation

acronym: IPASIRC

summary:
With regard to the fields of competence of advanced practice defined by the Order of October 22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma of advanced practice nurse mentioning renal disease, dialysis and renal transplantation (MRDT) and the latest recommendations of the French National Authority for Health (HAS) of July 1 2021 on the monitoring of patients with Chronic Kidney Disease (CKD), the Advanced Practice Nurse (APN) has its place in improving practices and the care pathway of patients suffering from end-stage chronic renal failure (CKD).

In the literature, there are a number of studies arguing the benefits of advanced practice nurse follow-up with patients suffering from chronic renal failure (CKD) in terms of improving their psycho-social and self-care skills. However, few studies, particularly in France, demonstrate its role in the coordination of care. By virtue of their training, advanced practice nurse with an disease, dialysis and renal transplantation (MRDT) specialization acquire skills in managing pretransplant assessment files and in planning the creation of arteriovenous fistula (AVF), which enable them to be autonomous and relevant professionals in the coordination of these processes. This is why it seems appropriate to look at the added value that advanced nursing practice can bring to the follow-up of these patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation - A Monocentric Study

acronym: TRANSBONE

summary: While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration. Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized. Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted . Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.


title: MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease

acronym: MIMA-P

summary: Patients with Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) may or may not develop Alzheimer's disease (AD) dementia. Yet identifying patients at risk is crucial: delaying the onset of the disease by 5 years could reduce prevalence by 50%. To achieve this, we need affordable biomarkers combined with clinically meaningful assessment tools. Current approaches (cognition, imaging or Tau and Amyloid peptide assays) lack precision or specificity (e.g., age-related memory deficits) and involve invasive and costly procedures, sometimes inaccessible in France (e.g., the "AT(N)" framework). Recently, quantitative diffusion MRI (dMRI) has identified in-vivo gray matter microstructural changes linked to hyperphosphorylated Tau protein, which are of great diagnostic value. Still, we ignore whether and how these changes are responsible for early memory impairment in AD. The MIMA-P project will combine multi-compartment models of the high-resolution diffusion signal with a cognitive assessment of memory based on recent models of medial temporal lobe function to assess the relevance of a new affordable, rapid and non-invasive early marker of the disease.

status: Not yet recruiting

lead_sponsor: Rennes University Hospital


title: Study of the Interest of Patients Undergoing Anti-thrombotic Treatment in a Digital Application of Therapeutic Assistance

acronym: APPLIAC

summary:
Medical ethics encourages medical personal to actively care for patients, however old they may be, if they have maintained their physical autonomy and mental integrity to travel the path of medical care together. Many of the patients are in this situation today and their age does not seem to be a limiting factor in the care required.

For more than 60 years, antithrombotics have played a major role in the management of thromboembolic and arterioatheromatous diseases. the doctors have therefore seen the advent of low molecular weight heparins, new platelet antiaggregants and then direct oral anticoagulants.

If their contribution is no longer discussed today, it is necessary to take into consideration the risks they cause, particularly in terms of haemorrhage. Indeed, antithrombotics are the leading cause of serious adverse reactions in France with anti-vitamins K (AVK) which are the leading cause of hospitalization for severe iatrogeny in France. This risk is increased by the coexistence of haemorrhagic risk factors: drug interaction, misuse, failure to comply with contraindications and precautions for use, especially as exposure to these drugs increases with age.

status: Terminated

ReferenceCitation: Linkins LA, Choi PT, Douketis JD. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. Ann Intern Med. 2003 Dec 2;139(11):893-900. doi: 10.7326/0003-4819-139-11-200312020-00007.

ReferenceCitation: Dahri K, Loewen P. The risk of bleeding with warfarin: a systematic review and performance analysis of clinical prediction rules. Thromb Haemost. 2007 Nov;98(5):980-7.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY

acronym: MIRESPILEPSY

summary:
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is an urgent need to develop specific therapeutic approaches to tackle this issue.

The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%.

A total of 50 patients will be included over a period of one year. Patients undergoing long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.

It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction (controls).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurophysiologie Clinique Hôpital La Timone

intervention_type: Genetic