title: Interest of Plasma microRNAs Assay in ICU Acquired Muscle Weakness Diagnosis

acronym: µARN

summary:
ICU acquired muscle weakness (IAMW) is a common disease that is associated with high morbidity and mortality. Patients with septic shock are particularly at risk.

The diagnosis of IAMW is clinical and based on the rating of the Medical Research Council score (MRC score). A MRC score lower than 48 defines the IAMW. But this evaluation is only usable in sufficiently awaken patients.

Several studies have highlighted the role of microRNAs in regulating physiological processes and diseases related to the skeletal muscles. To date, no study was interested in IAMW.

The aim of this study is to compare the microRNA detection kinetics on the appearance of IAMW.

In septic shock patients, the kinetics of nine microRNAs will be compared between two groups: those with IAMW (IAMW + group) and those without IAMW (IAMW - group).

location_facility:
Ch Roanne
Chu Saint-Etienne


type: Other Identifier

title: Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

acronym: Nutriprophy

summary: The purpose of the study is to build and assess the feasibility of a therapeutic education program, constructed in collaboration with the urologists of the University Hospital of Saint Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the amplitude of the development of insulin resistance and side effects of androgen deprivation therapy in patients treated with androgen deprivation in the context of an evolutive prostate cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

ReferenceCitation: Golant M, Altman T, Martin C. Managing cancer side effects to improve quality of life: a cancer psychoeducation program. Cancer Nurs. 2003 Feb;26(1):37-44; quiz 45-6.

ReferenceCitation: Diefenbach MA, Butz BP. A multimedia interactive education system for prostate cancer patients: development and preliminary evaluation. J Med Internet Res. 2004 Jan 21;6(1):e3.

ReferenceCitation: Pérol D, Toutenu P, Lefranc A, Régnier V, Chvetzoff G, Saltel P, Chauvin F. [Therapeutic education in oncology: involving patient in the management of cancer]. Bull Cancer. 2007 Mar;94(3):267-74. Review. French.

ReferenceCitation: Rébillard X, Grosclaude P, Lebret T, Patard JJ, Pfister C, Richaud P, Rigaud J, Salomon L, Soulié M. [Projected incidence and mortality from urologic cancer in France in 2010.]. Prog Urol. 2010 Nov;20 Suppl 4:S211-4. doi: 10.1016/S1166-7087(10)70041-5. French.

ReferenceCitation: Crook JM, O'Callaghan CJ, Duncan G, Dearnaley DP, Higano CS, Horwitz EM, Frymire E, Malone S, Chin J, Nabid A, Warde P, Corbett T, Angyalfi S, Goldenberg SL, Gospodarowicz MK, Saad F, Logue JP, Hall E, Schellhammer PF, Ding K, Klotz L. Intermittent androgen suppression for rising PSA level after radiotherapy. N Engl J Med. 2012 Sep 6;367(10):895-903. doi: 10.1056/NEJMoa1201546. Erratum in: N Engl J Med. 2012 Dec 6;367(23):2262.

ReferenceCitation: Alibhai SM, Gogov S, Allibhai Z. Long-term side effects of androgen deprivation therapy in men with non-metastatic prostate cancer: a systematic literature review. Crit Rev Oncol Hematol. 2006 Dec;60(3):201-15. Epub 2006 Jul 24. Review.

ReferenceCitation: Hoffmann P, Schulman C. Complications of androgen-deprivation therapy in prostate cancer: the other side of the coin. BJU Int. 2009 Apr;103(8):1020-3.

ReferenceCitation: Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283. Review.

ReferenceCitation: Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005 Jan 13;352(2):154-64.

ReferenceCitation: Herr HW, O'Sullivan M. Quality of life of asymptomatic men with nonmetastatic prostate cancer on androgen deprivation therapy. J Urol. 2000 Jun;163(6):1743-6.

ReferenceCitation: Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56.

ReferenceCitation: Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500.

ReferenceCitation: Tsai HK, D'Amico AV, Sadetsky N, Chen MH, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007 Oct 17;99(20):1516-24. Epub 2007 Oct 9.

ReferenceCitation: D'Amico AV, Denham JW, Crook J, Chen MH, Goldhaber SZ, Lamb DS, Joseph D, Tai KH, Malone S, Ludgate C, Steigler A, Kantoff PW. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol. 2007 Jun 10;25(17):2420-5.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility:
Institut de Cancérologie de la Loire
CHU Saint-Etienne

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy

acronym: ETICCO

summary:
The purpose of this study is to assess the effectiveness of a nurse telephone interview in the management of cancer patients treated by oral chemotherapy. This is a multicenter prospective randomized controlled pragmatic interventional trial conducted in collaboration with two oncology care facilities. Eligible population consists of all patients suffering from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients will be enrolled in the study. The experimental group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care, and telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care.

The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity grades).

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Bouleftour W, Muron T, Guillot A, Tinquaut F, Rivoirard R, Jacquin JP, Saban-Roche L, Boussoualim K, Tavernier E, Augeul-Meunier K, Collard O, Mery B, Pupier S, Oriol M, Bourmaud A, Fournel P, Vassal C. Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study). Support Care Cancer. 2021 Aug;29(8):4257-4267. doi: 10.1007/s00520-020-05955-3. Epub 2021 Jan 7.

family: Bouleftour

full_name: Wafa Bouleftour

given: Wafa

sequence: first

family: Muron

full_name: Thierry Muron

given: Thierry

sequence: additional

family: Guillot

full_name: Aline Guillot

given: Aline

family: Tinquaut

full_name: Fabien Tinquaut

given: Fabien

family: Rivoirard

full_name: Romain Rivoirard

given: Romain

family: Jacquin

full_name: Jean-Philippe Jacquin

given: Jean-Philippe

family: Saban-Roche

full_name: Léa Saban-Roche

given: Léa

family: Boussoualim

full_name: Karima Boussoualim

given: Karima

family: Tavernier

full_name: Emmanuelle Tavernier

given: Emmanuelle

family: Augeul-Meunier

full_name: Karine Augeul-Meunier

given: Karine

family: Collard

full_name: Olivier Collard

given: Olivier

family: Mery

full_name: Benoite Mery

given: Benoite

family: Pupier

full_name: Sidonie Pupier

given: Sidonie

family: Oriol

full_name: Mathieu Oriol

given: Mathieu

family: Bourmaud

full_name: Aurélie Bourmaud

given: Aurélie

family: Fournel

full_name: Pierre Fournel

given: Pierre

family: Vassal

full_name: C. Vassal

given: C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Supportive Care in Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility:
Hopital Privé de la Loire
Institut de Cancerologie de la Loire

status_simplified: Unknown


title: SERum-bank for PANcreatic Cancer

acronym: SERPAN

summary:
This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (<2cm), the chances of recovery are very good.

But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.

Today, there is no any effective means of detection... Blood markers can be a simple means of early detection

study_start_date_type: Actual

status: Recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Institut Cancérologique Lucien Newirth (ICLN)

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: WeanINg From Mechanical Ventilation for ARDS CovId-19 Patients Guided by Combined Thoracic UltraSound: a Prospective, Multicenter, Randomized, Open-label, Parallel-group Clinical Trial

acronym: INVICTUS

summary: The most feared complication of COVID-19 infection is the occurrence of an acute respiratory distress syndrome (ARDS) that requires ICU admission and prolonged mechanical ventilation in more than 2% of the affected patients. Establishing the correct time to extubate mechanically ventilated patients is a crucial issue in the critical care practice. Delayed extubation has several consequences such as patient's mortality, health-care-related complications, neuropsychological adverse events. The aim of the INVICTUS study is to evaluate whether a CTUS-based MV weaning strategy could reduce the duration of mechanical ventilation of ARDS COVID-19 ICU patients by 72 hours, compared with usual medical care.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de LIMOGES
CHU de TOULOUSE

intervention_type: Diagnostic Test


title: COVID-19 Study of the Serological Response Against the SARS-CoV-2 Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur

acronym: Curie-O-SA

summary:
This research proposes to study a large healthy population active for the presence of antibodies directed against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus and this over time.

After verification of the inclusion criteria and information by the coordinating investigative doctor, the volunteers sign a written consent. A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data.

The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0 (day of inclusion), between 6 weeks and 3 months ,6 months and 12 months post-inclusion.

Each blood sample consists of a collection of 5 mL of blood in a dry tube. The serum samples will be extracted and collected prospectively from the blood samples.

The nasopharyngeal swabs will be performed at 3 times: , between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff who have had at least one of the following four criteria on the sample or questionnaire carried out at T0:

have had RT-PCR+
and/or presence of antibodies at the 95% threshold
and/or anosmia/ageusia
and/or digestive syndrome with associated respiratory signs. In case of infection between sampling times, if the volunteer meets one of the four criteria above, a nasopharyngeal swab will be performed during the following visits.

The nasopharyngeal swab shall also be proposed to volunteers not meeting the 4 above listed criteria in order to have a control group (about 100 volunteers) for future statistical analyses.

If the volunteers accept, naso-pharyngeal swab shall be performed between 6 weeks and 3 months, 6 months and 12 months after inclusion.

For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples and nasopharyngeal swabs shall be performed.

Those shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.

The blood samplings and nasopharyngeal swabs will be performed at 4 times for Institute Pasteur personnel: at T0 (inclusion day), between 6 weeks and 3 months, at 6 months and 12 months post-inclusion

status: Active, not recruiting

primary_purpose: Health Services Research

lead_sponsor: Institut Curie

location_facility:
Institut Pasteur
Institut Curie


title: PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis

acronym: PROTONBIOMARKS

summary: This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.

time_perspective: Other

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard


title: Study of the Pathogenesis of Olfactory Disorders in COVID-19

acronym: COVIDSMELL

summary: This study is a case-control study to characterize the molecular and cellular anomalies of the olfactory epithelium of COVID-19 patients with isolated anosmia, by comparison with the olfactory epithelium of non-infected subjects.

time_perspective: Cross-Sectional

lead_sponsor: Institut Pasteur

location_facility:
Hôpital Lariboisière, Policlinique
Hôpital Lariboisière, Service ORL

intervention_type: Other


title: Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est

summary:
Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive).

This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19, by analyzing associations between treatments and outcomes.

All data are collected in electronical records during routine practice.

lead_sponsor: Centre Hospitalier Intercommunal Robert Ballanger


title: Is Protein S100B a Predictor of First-to-chronic Seizure Conversion in Adults? A Prognostic Cohort Study

summary:
Seizures represent an important clinical problem, accounting for at least 40% of adult onset epilepsy. Predicting seizure recurrence in subjects experiencing a first seizure is difficult due to the lack of prognostic biomarkers. Recent evidence has indicated that blood-brain barrier (BBB) dysfunction constitutes an etiological factor to seizures. In particular, it has been shown that modification of BBB permeability is associated with seizure activity. In addition, it was demonstrated that BBB permeability can be assessed by measuring serum level of the protein S100B. Based on these data and considerations the investigators will test whether the extent of BBB damage at time of first seizure is predictive for seizure recurrence.

The main objective of this study is to evaluate the association between the absolute (ng/ml) serum S100B levels (measured at time of the first seizure) and the experience, or not, of seizure recurrence within one year of follow-up.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study

summary: Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

ipd_sharing: Undecided

ipd_sharing_description: IPD may be available on request.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre Hospitalier Intercommunal Le Raincy-Montfermeil

location_facility: Centre Hospitalier Intercommunal Robert Ballanger


title: Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy (PRURICHECKPOINT)

acronym: PRURICHECKPOIN

summary: Immune checkpoint inhibitors (ICIs) are commonly used in the therapeutic arsenal of metastatic melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4) and anti-programmed death-1 (anti-PD1) respectively. These treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. Their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. Among those, pruritus is frequently reported as a side effect of these treatments. Its incidence has been estimated between 11% and 47%. Pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. Until now, ICI-related pruritus has been poorly studied and it is not understood. In the literature, data on the presence and characteristics of pruritus in patients treated by ICIs were provided, without analyzing the causes of this pruritus. Indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of ICIs. Some authors reported a correlation between the occurrence of cutaneous adverse events under ICIs and the survival. The principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas. The other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH de Landerneau
CHRU de Brest


title: Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive MOtrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy: a Trial Multicentre Randomized Control With Medico-economic Evaluation

acronym: MOOV

summary:
One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility:
Fondation ILDYS - Site de Ty Yann
Les Capucins


title: Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis

acronym: ELASTOP-AS

summary:
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.

The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Rouen

location_facility:
CHU de Rouen
CHU Caen

intervention_type: Device


ReferenceType: result

ReferenceCitation: Cottu P, D'Hondt V, Dureau S, Lerebours F, Desmoulins I, Heudel PE, Duhoux FP, Levy C, Mouret-Reynier MA, Dalenc F, Frenel JS, Jouannaud C, Venat-Bouvet L, Nguyen S, Ferrero JM, Canon JL, Grenier J, Callens C, Gentien D, Lemonnier J, Vincent-Salomon A, Delaloge S. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer. Ann Oncol. 2018 Dec 1;29(12):2334-2340. doi: 10.1093/annonc/mdy448.

family: Cottu

full_name: P. Cottu

given: P.

family: D'Hondt

full_name: V. D'Hondt

given: V.

family: Dureau

full_name: S. Dureau

given: S.

family: Lerebours

full_name: F. Lerebours

given: F.

family: Desmoulins

full_name: I. Desmoulins

given: I.

family: Heudel

full_name: P.-E. Heudel

family: Duhoux

full_name: F.P. Duhoux

family: Levy

full_name: C. Levy

family: Mouret-Reynier

full_name: M.-A. Mouret-Reynier

family: Dalenc

full_name: F. Dalenc

family: Frenel

full_name: J.-S. Frenel

family: Jouannaud

full_name: C. Jouannaud

family: Venat-Bouvet

full_name: L. Venat-Bouvet

given: L.

family: Nguyen

full_name: S. Nguyen

family: Ferrero

full_name: J.-M. Ferrero

family: Canon

full_name: J.-L. Canon

family: Grenier

full_name: J. Grenier

given: J.

family: Callens

full_name: C. Callens

family: Gentien

full_name: D. Gentien

given: D.

family: Lemonnier

full_name: J. Lemonnier

family: Vincent-Salomon

full_name: A. Vincent-Salomon

given: A.

family: Delaloge

full_name: S. Delaloge

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

title: Open-label, Randomized, Multicenter, International, Parallel Exploratory Phase II Study, Comparing 3 FEC-3 Docetaxel Chemotherapy to Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

summary: The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment.


title: Multicenter Prospective Study of the Efficacy of Stereotactic Lung Radiation Therapy After Concomitant Radio-chemotherapy for Unresectable Stage III Non-small Cell Lung Carcinoma (NSCLC) With Peripheral Primary Tumor.

summary:
The purpose of this study is to evaluate the efficacy of stereotactic lung radiation therapy after concomitant radiochemotherapy for unresectable stage III non-small cell lung carcinoma (NSCLC) with peripheral primary tumor.

Evaluate in terms of local control rate at 6 months the addition of stereotactic radiotherapy after concurrent chemoradiotherapy in the treatment of mediastinal non-resectable stage III NSCLC having a peripheral primary tumor.

The number of patients required in this multicenter prospective study is 70.

This is a prospective, multicenter, non comparative and non randomized study.

status: Terminated

primary_purpose: Treatment

location_facility:
Centre Leon Berard
Hopital Nord-Ouest

intervention_type: Radiation


title: Pharmacological Evaluation of Hormonal Contraceptive Treatments in Obese Women Before and After Bariatric Surgery

acronym: OBECO

summary: The aim of our study is to assess the concentrations of different oral contraceptive agents in morbid obese women before and after two types of bariatric surgeries (RYGB and sleeve gastrectomy) in order to study the role of the surgery and the role of body weight on drug concentrations, and to compare these concentrations with those of normal-weight women.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Ambroise Paré
Pitié Salpetriere Hospital


title: Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection

acronym: CRP-Track

summary: Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Nantes
Centre Hospitalier Departemental Vendee


title: Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1

summary: The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

lead_sponsor: InnaVirVax

location_facility:
Hôpital Cochin Saint Vincent de Paul
Hôpital Pitié Salpêtrière


title: Parenteral Nutrition and Bone Trophicity

summary:
Recent progress in parenteral nutrition has contributed to improve vital prognosis and to reduce morbidity in patients with severe intestinal failure.

Currently, home parenteral nutrition is the only alternative to prolonged hospitalization for those patients. However, long-term parenteral nutrition can result in complications especially in bone, such as osteopenia or osteomalacia, then increasing the risk of fractures. Children are especially at risk because of bone growth and peak mineralization acquisition during puberty.

Moreover, frequency and risk factors of those complications are not well documented for children.

Dual-energy X-ray Absorptiometry (DXA) is considered as the golden standard for bone mineralization measurement. In pediatrics, this technique has some limits such as the underestimation of Bone Mineral Density (BMD) in short stature, the overestimation of the BMD in tall children, and the inability to distinguish cortical from trabecular bone or to evaluate the bone microarchitecture.

HR-pQCT, High Resolution peripheral Quantitative Computed Tomography enables noninvasive assessment of bone microarchitecture (virtual bone biopsy) using a radiation similar to DXA. However this technique has never been validated in patients with long-term parenteral nutrition.

During the usual follow-up of the patients, HR-pQCT will be the only exam which will come in addition to the routine medical tests.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant


title: Role of Genetic, Neurophysiological and Psychological Factors in the Development of Postsurgical Neuropathic Pain After Breast Surgery for Cancer

summary: The objective of these cohorts is to detect potential genetic, neurophysiological psychological and cognitive risk factors for the development of chronic postsurgical pain including neuropathic pain.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Hôpital Foch
Hôpital Ambroise Paré


title: Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma

acronym: POPSUD

summary: To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study

lead_sponsor: University Hospital, Limoges

location_facility:
Bordeaux Hospital
Limoges Hospital


title: Burden of Staphylococcus Lugdunensis Infections in Hospitalized Patients: a Prospective, Bicentric Cohort Study

acronym: INHOSTAL

summary:
Staphylococcus lugdunensis is a coagulase-negative Staphylococcus (CoNS) belonging to the normal human skin flora. It is responsible for a wide variety of infections, such as skin and soft tissue infections, bone and joint infections, but also bacteraemia and endocarditis. Although the implication of S. lugdunensis in infectious diseases is proven, many questions remain both in terms of clinical and molecular epidemiology.

In this context, INHOSTAL is the first prospective, bicentric study, which will comprehensively include all patients with S. lugdunensis infection (based on microbiological and clinical data) in two French university hospitals. The main objective of this study is thus to determine the incidence of S. lugdunensis infections in hospitalized patients.

Moreover, the originality of this project is to compare the characteristics of S. lugdunensis infections with those of infections caused by S. aureus and other species of CoNS. Thereby, the clinical epidemiology of these infections will be compared (i.e. types of infection, mode of acquisition, host risk factors…).

Finally, complete genome of all S. lugdunensis strains will be sequenced using Illumina technology and analyzed to describe the molecular epidemiology as well as the molecular mechanisms of antibiotic resistance (compared to antibiotic susceptibility evaluated by minimum inhibitory concentrations determined by Sensititre technique). This will enable to identify if predominant clones exist, and if some strains are spreading into the hospital.

The duration of the study period will be 18 months, to allow the inclusion of a total of 300 patients: 100 S. lugdunensis infections, as well as 100 S. aureus infections and 100 other species of CoNS infections.

location_facility:
Rouen University Hospital
Caen University Hospital


title: Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort

acronym: AMPLIFy

summary: The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Nantes
University Hospital of Angers


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: STRABO

type: EudraCT Number

source: euctr

title: Effect of Neuromuscular Blockade on the Oculomotor by Not Squinting Child

summary:
Strabismus is a common condition (4-6% of the population) . The screening and treatment is a public health issue. Indeed, beyond the disfigurement, this disease is very supplier of amblyopia which is definitive if it is not detected and treated early (before 6 years old).

Initial treatment of strabismus is medical with orthoptic reeducation through penalization of the better eye in case of amblyopia or wearing optical correction in case of associated refractive disorder.

The second step is the treatment of strabismus is the surgery, when medical treatment has not resulted in a recovery of the visual axes. The principle of surgery is to weaken or strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint deviation. The main difficulty of surgical treatment is to assess the amount of strengthening or weakening muscles to do in order to obtain the best result and for a long time.

The investigators know that the postmortem anatomical position of the eyes is generally a slight elevation and divergence, but is inferior to the angle of divergence of the orbital axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular junction, can be used to reproduce this situation in normal subjects.

The sign of general anesthesia is then to evaluate the angle of strabismus when the patient is under deep general anesthesia and with a complete muscle relaxation, obtained only when curarised it. If one or both eyes are recovering under general anesthesia, strabismus is mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes one eye is justified. A combination of both is possible (down + wireless), guided by the importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of general anesthesia is however less known and most poorly quantified in healthy subjects. Yet it seems very important to determine what is deviation in normal subjects after neuromuscular blockade, as his eye movement is also subject to mechanical factors and spastic. This would indicate whether the state of rectitude (no strabismus) is the result of a deviation at complete rest (appearing under general anesthesia) and corrected by spastic elements wakefulness or, in another case this righteousness is already present in the state of general anesthesia (due to static factors) and slightly modified by enlightenment.


title: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective

acronym: IPA

summary:
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.

The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).

In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.

The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.

location_facility:
CHU de Nantes
Centre Hospitalier Departemental Vendee


title: Non Traumatic Aortic Dissection : Chain of Care and Pre-hospital Risk Factors, a Retrospective, Multicenter Study

acronym: FFDA

summary:
Background :

Time between symptoms onset and treatment initiation is crucial in Acute aortic dissection (AAD). An anti-hypertensive treatment can be rapidly initiated before the arrival in Emergency Department (ED). A better understanding of the chain of care between symptoms onset and surgery could lead to a reduction of morbi-mortality. Our study have the objective to describe the chain of care of patients with AAD in the ED.

Methods :

This is an observational, retrospective, multicenter study. Patients were detected with a discharge of diagnostic of aortic dissection (ICD I71.0) in university medical center of Besançon. Data collection : patients records in the 8 hospitals centers of the area Franche-Comté.

ReferenceCitation: Axelsson C, Karlsson T, Pande K, Wigertz K, Örtenwall P, Nordanstig J, Herlitz J. A description of the prehospital phase of aortic dissection in terms of early suspicion and treatment. Prehosp Disaster Med. 2015 Apr;30(2):155-62. doi: 10.1017/S1049023X15000060. Epub 2015 Feb 10.

family: Axelsson

full_name: Christer Axelsson

given: Christer

family: Karlsson

full_name: Thomas Karlsson

given: Thomas

family: Pande

full_name: Katarina Pande

given: Katarina

family: Wigertz

full_name: Kristin Wigertz

given: Kristin

family: Örtenwall

full_name: Per Örtenwall

given: Per

family: Nordanstig

full_name: Joakim Nordanstig

given: Joakim

family: Herlitz

full_name: Johan Herlitz

given: Johan

journal_name: Prehospital and Disaster Medicine

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

title: A Description of the Prehospital Phase of Aortic Dissection in Terms of Early Suspicion and Treatment

ReferenceCitation: Dixon M. Misdiagnosing aortic dissection: a fatal mistake. J Vasc Nurs. 2011 Dec;29(4):139-46. doi: 10.1016/j.jvn.2011.08.003.

family: Dixon

full_name: Maria Dixon

given: Maria

journal_name: Journal of Vascular Nursing

title: Misdiagnosing aortic dissection: A fatal mistake

ReferenceCitation: Nazerian P, Giachino F, Vanni S, Veglio MG, Castelli M, Lison D, Bitossi L, Moiraghi C, Grifoni S, Morello F. Diagnostic performance of the aortic dissection detection risk score in patients with suspected acute aortic dissection. Eur Heart J Acute Cardiovasc Care. 2014 Dec;3(4):373-81. doi: 10.1177/2048872614527010. Epub 2014 Mar 6.

name: Emergency Department, Careggi University Hospital, Firenze, Italy

family: Nazerian

full_name: Peiman Nazerian

given: Peiman

name: Emergency Department, Molinette University Hospital, Torino, Italy

family: Giachino

full_name: Francesca Giachino

given: Francesca

family: Vanni

full_name: Simone Vanni

given: Simone

family: Veglio

full_name: Maria G Veglio

given: Maria G

family: Castelli

full_name: Matteo Castelli

given: Matteo

family: Lison

full_name: Davide Lison

given: Davide

family: Bitossi

full_name: Luca Bitossi

given: Luca

family: Moiraghi

full_name: Corrado Moiraghi

given: Corrado

family: Grifoni

full_name: Stefano Grifoni

given: Stefano

family: Morello

full_name: Fulvio Morello

given: Fulvio

journal_name: European Heart Journal: Acute Cardiovascular Care

ReferenceCitation: Pape LA, Awais M, Woznicki EM, Suzuki T, Trimarchi S, Evangelista A, Myrmel T, Larsen M, Harris KM, Greason K, Di Eusanio M, Bossone E, Montgomery DG, Eagle KA, Nienaber CA, Isselbacher EM, O'Gara P. Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection: 17-Year Trends From the International Registry of Acute Aortic Dissection. J Am Coll Cardiol. 2015 Jul 28;66(4):350-8. doi: 10.1016/j.jacc.2015.05.029.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Harris KM, Strauss CE, Eagle KA, Hirsch AT, Isselbacher EM, Tsai TT, Shiran H, Fattori R, Evangelista A, Cooper JV, Montgomery DG, Froehlich JB, Nienaber CA; International Registry of Acute Aortic Dissection (IRAD) Investigators. Correlates of delayed recognition and treatment of acute type A aortic dissection: the International Registry of Acute Aortic Dissection (IRAD). Circulation. 2011 Nov 1;124(18):1911-8. doi: 10.1161/CIRCULATIONAHA.110.006320. Epub 2011 Oct 3.

name: From the Minneapolis Heart Institute Foundation at Abbott–Northwestern Hospital, Minneapolis, MN (K.M.H., C.E.S.); Cardiovascular Division (C.E.S., A.T.H.) and Division of Epidemiology and Community Health (A.T.H.), School of Public Health, University of Minnesota, Minneapolis; University of Michigan, Ann Arbor (K.A.E., H.S., J.V.C., D.G.M., J.B.F.); Massachusetts General Hospital, Boston (E.M.I.); University of Colorado, Denver (T.T.T.); University Hospital S. Orsola, Bologna, Italy (R.F.);...

name: for the International Registry of Acute Aortic Dissection (IRAD) Investigators

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Correlates of Delayed Recognition and Treatment of Acute Type A Aortic Dissection

ReferenceCitation: Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264. Review.

name: Hospital General Universitari Vall d’Hebron, CIBER-CV, Barcelona, Spain (A.E.).

name: Massachusetts General Hospital, Boston (E.M.I.).

name: Robert-Bosch Krankenhaus, Stuttgart, Germany (U.S.).

name: IRCCS Policlinico San Donato, Italy (S.T.).

name: Washington University School of Medicine, St. Louis, MO (A.C.B.).

name: Tromso University Hospital, Norway (T.M.).

name: Minneapolis Heart Institute, MN (K.M.H.).

name: University of Calgary Medical Centre, Alberta, Canada (S.H.).

name: Brigham and Women’s Hospital, Boston, MA (P.O’G.).

name: University of Leicester, United Kingdom (T.S.).

name: The Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom (C.A.N.).

name: University of Michigan, Ann Arbor (K.A.E.).

ReferenceCitation: Booher AM, Isselbacher EM, Nienaber CA, Trimarchi S, Evangelista A, Montgomery DG, Froehlich JB, Ehrlich MP, Oh JK, Januzzi JL, O'Gara P, Sundt TM, Harris KM, Bossone E, Pyeritz RE, Eagle KA; IRAD Investigators. The IRAD classification system for characterizing survival after aortic dissection. Am J Med. 2013 Aug;126(8):730.e19-24. doi: 10.1016/j.amjmed.2013.01.020.

title: The IRAD Classification System for Characterizing Survival after Aortic Dissection

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Nord Franche-Comté
CHU de Besançon


title: Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

acronym: MODOBAT

summary: In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.

location_facility:
Hopital Nord Franche-Comté
CHU Besançon


title: Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

acronym: NOSO-COR

summary:
Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.

The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.

Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.

The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.

Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.

ReferenceCitation: Vanhems P. A breath of humanity in the era of Covid-19 vaccine. Vaccine. 2021 Jun 23;39(28):3649. doi: 10.1016/j.vaccine.2021.05.052. Epub 2021 May 24.

family: Vanhems

full_name: Philippe Vanhems

given: Philippe

journal_name: Vaccine

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

ReferenceCitation: Saadatian-Elahi M, Picot V, Hénaff L, Pradel FK, Escuret V, Dananché C, Elias C, Endtz HP, Vanhems P. Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project. BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.

apc_source: openAPC

family: Saadatian-Elahi

full_name: Mitra Saadatian-Elahi

given: Mitra

family: Picot

full_name: Valentina Picot

given: Valentina

family: Hénaff

full_name: Laetitia Hénaff

given: Laetitia

family: Pradel

full_name: Florence K Pradel

given: Florence K

family: Escuret

full_name: Vanessa Escuret

given: Vanessa

family: Dananché

full_name: Cédric Dananché

given: Cédric

family: Elias

full_name: Christelle Elias

given: Christelle

family: Endtz

full_name: Hubert P Endtz

given: Hubert P

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Service Hygiène, Epidémiologie et Prévention


title: Study of the Predictive Value of a Signature of 10 microRNA in Thyroid Cytologies of Undetermined Type

acronym: PREDICYTHY

summary: The aim is to validate a signature of 10 microRNA (micro Ribonucleic acid) selected in a first exploratory study allowing the stratification of the cytologies of indeterminate type (In a first step, the teams will focus on standardising the pre-analytical stages and defining a threshold of positivity. The results of microRNA signature on a cohort of 70 patients will be compared with the ultrasound and then histological data of the resection specimen.

ReferenceCitation: Jacques C, Guillotin D, Fontaine JF, Franc B, Mirebeau-Prunier D, Fleury A, Malthiery Y, Savagner F. DNA microarray and miRNA analyses reinforce the classification of follicular thyroid tumors. J Clin Endocrinol Metab. 2013 May;98(5):E981-9. doi: 10.1210/jc.2012-4006. Epub 2013 Apr 8.

ReferenceCitation: Russ G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8.

ReferenceCitation: Paschke R, Cantara S, Crescenzi A, Jarzab B, Musholt TJ, Sobrinho Simoes M. European Thyroid Association Guidelines regarding Thyroid Nodule Molecular Fine-Needle Aspiration Cytology Diagnostics. Eur Thyroid J. 2017 Jul;6(3):115-129. doi: 10.1159/000468519. Epub 2017 May 19.

ReferenceCitation: Cantara S, Marzocchi C, Pilli T, Cardinale S, Forleo R, Castagna MG, Pacini F. Molecular Signature of Indeterminate Thyroid Lesions: Current Methods to Improve Fine Needle Aspiration Cytology (FNAC) Diagnosis. Int J Mol Sci. 2017 Apr 6;18(4). pii: E775. doi: 10.3390/ijms18040775. Review.

ReferenceCitation: Sahli ZT, Smith PW, Umbricht CB, Zeiger MA. Preoperative Molecular Markers in Thyroid Nodules. Front Endocrinol (Lausanne). 2018 Apr 18;9:179. doi: 10.3389/fendo.2018.00179. eCollection 2018. Review.

ReferenceCitation: Dedhia PH, Rubio GA, Cohen MS, Miller BS, Gauger PG, Hughes DT. Potential effects of molecular testing of indeterminate thyroid nodule fine needle aspiration biopsy on thyroidectomy volume. World J Surg. 2014 Mar;38(3):634-8. doi: 10.1007/s00268-013-2430-x.

ReferenceCitation: Nikiforov YE, Seethala RR, Tallini G, Baloch ZW, Basolo F, Thompson LD, Barletta JA, Wenig BM, Al Ghuzlan A, Kakudo K, Giordano TJ, Alves VA, Khanafshar E, Asa SL, El-Naggar AK, Gooding WE, Hodak SP, Lloyd RV, Maytal G, Mete O, Nikiforova MN, Nosé V, Papotti M, Poller DN, Sadow PM, Tischler AS, Tuttle RM, Wall KB, LiVolsi VA, Randolph GW, Ghossein RA. Nomenclature Revision for Encapsulated Follicular Variant of Papillary Thyroid Carcinoma: A Paradigm Shift to Reduce Overtreatment of Indolent Tumors. JAMA Oncol. 2016 Aug 1;2(8):1023-9. doi: 10.1001/jamaoncol.2016.0386.

ReferenceCitation: Faquin WC, Wong LQ, Afrogheh AH, Ali SZ, Bishop JA, Bongiovanni M, Pusztaszeri MP, VandenBussche CJ, Gourmaud J, Vaickus LJ, Baloch ZW. Impact of reclassifying noninvasive follicular variant of papillary thyroid carcinoma on the risk of malignancy in The Bethesda System for Reporting Thyroid Cytopathology. Cancer Cytopathol. 2016 Mar;124(3):181-7. doi: 10.1002/cncy.21631. Epub 2015 Oct 12.

ReferenceCitation: Paulson VA, Shivdasani P, Angell TE, Cibas ES, Krane JF, Lindeman NI, Alexander EK, Barletta JA. Noninvasive Follicular Thyroid Neoplasm with Papillary-Like Nuclear Features Accounts for More Than Half of "Carcinomas" Harboring RAS Mutations. Thyroid. 2017 Apr;27(4):506-511. doi: 10.1089/thy.2016.0583. Epub 2017 Feb 24.

ReferenceCitation: Strickland KC, Howitt BE, Marqusee E, Alexander EK, Cibas ES, Krane JF, Barletta JA. The Impact of Noninvasive Follicular Variant of Papillary Thyroid Carcinoma on Rates of Malignancy for Fine-Needle Aspiration Diagnostic Categories. Thyroid. 2015 Sep;25(9):987-92. doi: 10.1089/thy.2014.0612. Epub 2015 Jul 29.

ReferenceCitation: Nabhan F, Porter K, Lupo MA, Randolph GW, Patel KN, Kloos RT. Heterogeneity in Positive Predictive Value of RAS Mutations in Cytologically Indeterminate Thyroid Nodules. Thyroid. 2018 Jun;28(6):729-738. doi: 10.1089/thy.2017.0635. Epub 2018 May 16.

ReferenceCitation: Finoux AL, Chartrand P. [Oncogenic and tumour suppressor microRNAs]. Med Sci (Paris). 2008 Dec;24(12):1049-54. doi: 10.1051/medsci/200824121049. Review. French.

ReferenceCitation: Boufraqech M, Klubo-Gwiezdzinska J, Kebebew E. MicroRNAs in the thyroid. Best Pract Res Clin Endocrinol Metab. 2016 Oct;30(5):603-619. doi: 10.1016/j.beem.2016.10.001. Epub 2016 Nov 1. Review.

ReferenceCitation: Dom G, Frank S, Floor S, Kehagias P, Libert F, Hoang C, Andry G, Spinette A, Craciun L, de Saint Aubin N, Tresallet C, Tissier F, Savagner F, Majjaj S, Gutierrez-Roelens I, Marbaix E, Dumont JE, Maenhaut C. Thyroid follicular adenomas and carcinomas: molecular profiling provides evidence for a continuous evolution. Oncotarget. 2017 Dec 8;9(12):10343-10359. doi: 10.18632/oncotarget.23130. eCollection 2018 Feb 13.

ReferenceCitation: Titov SE, Demenkov PS, Ivanov MK, Malakhina ES, Poloz TL, Tsivlikova EV, Ganzha MS, Shevchenko SP, Gulyaeva LF, Kolesnikov NN. Selection and validation of miRNAs as normalizers for profiling expression of microRNAs isolated from thyroid fine needle aspiration smears. Oncol Rep. 2016 Nov;36(5):2501-2510. doi: 10.3892/or.2016.5113. Epub 2016 Sep 20.

ReferenceCitation: Lithwick-Yanai G, Dromi N, Shtabsky A, Morgenstern S, Strenov Y, Feinmesser M, Kravtsov V, Leon ME, Hajdúch M, Ali SZ, VandenBussche CJ, Zhang X, Leider-Trejo L, Zubkov A, Vorobyov S, Kushnir M, Goren Y, Tabak S, Kadosh E, Benjamin H, Schnitzer-Perlman T, Marmor H, Motin M, Lebanony D, Kredo-Russo S, Mitchell H, Noller M, Smith A, Dattner O, Ashkenazi K, Sanden M, Berlin KA, Bar D, Meiri E. Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears. J Clin Pathol. 2017 Jun;70(6):500-507. doi: 10.1136/jclinpath-2016-204089. Epub 2016 Oct 26.

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

location_facility: Institut régional du Cancer de Montpellier


title: Antimicrobial Therapy for Ventilator-associated Pneumonia Among Patients Colonized With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae : Efficacy of a Strategy Using Piperacillin-tazobactam as Empirical Treatment.

acronym: PROBATAZO

summary: Antimicrobial resistance is a major threat worldwide and now concerns last-ressource antibiotics such as carbapenems. As the resistance to carbapenems is directly due to their use, their spare has become a public health emergency. Their efficacy in ventilator-associated pneumonia has never been compared to other classes of antibiotics such as piperacillin-tazobactam which can be an alternative to carbapenems.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Centre hospitalier de la Côte Basque
Hopital Pellegrin


title: Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test

acronym: PSORTI-BIO

summary: The investigators hypothesize that the inhibition of endogenous reverse transcriptase would: (1) reduce excess cytosolic DNA, stress initiating the inflammatory loop at the origin of psoriatic lesions, and (2) interrupt the loop and lighten lesions

location_facility:
CHU de Montpellier
CHU de Nimes


title: Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum

acronym: STADEH

summary: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Clinical studies have demonstrated a link between staphylococcal skin colonization and the pathogenesis of AD, but the implication of bacterial virulence factors remains largely uncharacterized. Finally, AD is often associated with herpes simplex skin infections. The aim of this project is to investigate the role of staphylococcal toxins in the exacerbation and maintenance of atopic skin inflammation and in the occurrence of infectious complications such as eczema herpeticum.

primary_purpose: Basic Science

lead_sponsor: Poitiers University Hospital

location_facility:
CHU de Poitiers
CHU de Bordeaux


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor and Pump Therapy in the Management of Type 1 Diabetes Prone to Hypoglycemia

summary: This study is a RCT of 3 month at home comparing closed-loop control (CLC) system vs sensor and pump therapy (S&P), with a 3-month extension phase, in Type 1 diabetic patient prone to hypoglycemia. After a 2-week run-in phase with blinded CGM, patients who spent 5% or more time below 70mg/dL will be eligible to continue. They will will be randomly assigned 2:1 to the use of closed-loop control (CLC) using Tandem Control-IQ vs S&P for 3 months, which is the timing of the primary outcome for the RCT. After 3 months, the S&P group will use CLC for up to 3 months and the CLC group will continue using CLC for up to 3 additional months.

ipd_sharing_description: Sharing with NIDDK

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital of Caen
UH Montpellier


title: Establishment of Squamous Cell Organoids of the Head and Neck to Assess Their Response to Innovative Therapies

acronym: ORGAVADS

summary: The emergence of tumor organoid cultures in recent years has made it possible to widen the repertoire of available preclinical tumor models and to bridge the gap between cell lines and tumors of xenografted patients in mice (PDXs).These organoids have the advantages of being able to be amplified fairly quickly after resection of the tumor, of having unlimited proliferation potential, a high rate of establishment success, and the possibility of being transfected and cryopreserved. These characteristics therefore allow them to summarize the clinical spectra of cancers, but also to be models for studying tumor progression as has been done with organoids for colorectal cancer. They are also very close morphologically and genetically to the tumor from which they derive.Finally, clinical trials are underway to determine whether the organoids of mammary, pulmonary and colorectal cancers can predict the response to patients' treatments and guide the therapeutic decision.It would therefore be possible to test multiple treatments on different samples. This would allow screening of a panel of treatments on a given tumor type but also to test a treatment ex vivo before administering it to the patient in vivo. This prospect is very interesting in particular in the tumors of the VADS where more than two thirds of the operated patients will benefit from a complementary treatment by radiotherapy and / or chemotherapy whose consequences can be important. Despite this adjuvant management, up to 30% of patients will relapse, highlighting a variable tumor chemosensitivity. This screening could make it possible to refine the choice of treatments adapted to each patient and thus limit the undesirable effects.The feasibility of establishing head and neck squamous cell organoid lines seems encouraging, with organoids derived from squamous cell carcinoma of the oral cavity and oropharynx having been recently established.

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU de Caen
Centre François Baclesse


title: Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study

acronym: COG-TAB-AGE

summary: Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.

location_facility:
Centre Henri Becquerel
Centre François Baclesse


title: Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy

acronym: GASTROXY

summary: Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: A Randomized Double-blinded Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome

acronym: NS-DUPI

summary: To date, there are no effective therapy for the management of Netherton Syndrome (NS) Patients use emollients with a limited efficacy on scaling and no efficacy on skin inflammation and pruritus. They may also use topical corticosteroids or calcineurin inhibitors in case of eczematous lesions. The use of therapies targeting skin inflammation has been reported in a few case reports. Their efficacy is very limited and their uses are limited because of the chronicity of the disease, the impaired skin barrier function and the risk for skin infections and skin cancers. Therefore, there is a huge medical need for novel therapies in NS.The expected consequences of this study are that a 16-week course of dupilumab will be more effective than placebo for the treatment of moderate to severe NS Dupilumab could therefore improve skin condition and quality of life.

lead_sponsor: University Hospital, Toulouse

location_facility:
Dermatology
Dermatologie Necker


title: Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study

acronym: MIDAS

summary:
Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.

The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.

location_facility: Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan

location_facility: Service de Médecine Gériatrique, CHU de LIMOGES


title: Source-monitoring Processes and Risk for Psychosis

acronym: SOURIPSY

summary:
Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Some studies have showed source-monitoring deficits in patients with schizophrenia as well as in individuals at ultra-high risk for psychosis (UHR) and in first-episode psychosis patients (FEP). Source-monitoring deficits have thus been proposed as a potential early risk factor for psychosis. However, further studies are needed to better characterize this deficit.

The aim of this project is to investigate source-monitoring performances in UHR, FEP patients and healthy controls (HC) and to characterize these deficits in terms of brain anatomy, basic auditory processes and social functioning.

lead_sponsor: Hôpital le Vinatier


title: Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus

summary:
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.

To be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results.

lead_sponsor: Nantes University Hospital

location_facility:
CHU d'Angers
CHU de Nantes


title: Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement

summary: This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.

lead_sponsor: Quantum Surgical

location_facility:
Chu Montpellier
Gustave Roussy Institut


title: Evaluation of the Right Ventricular Systolic Function Using Real-time Three-dimensional Echocardiography in Intensive Care Unit Patients

summary:
Right ventricular failure (RVF) is an independent factor of mortality for many pulmonary diseases. Currently, RVF is defined as the incapacity of the RV to maintain the flow without dilating to use the Frank-Starling law (i.e., increase of the ejection volume associated to an increase of the preload). RVF is associated to RV systolic dysfunction which is conventionally defined as a decrease of the RV ejection fraction (RVEF) < 45%.

In the intensive care unit (ICU), acute RVF is mainly due to the acute respiratory distress syndrome (ARDS), sepsis or septic shock, and less often to severe pulmonary embolism or RV infarction.

The anatomical complexity of the RV precludes any geometrical assumption to estimate its volume, hence its ejection fraction (EF) using two-dimensional (2D) echocardiography. For this reason, the evaluation of RV systolic function is currently based on parameters used as surrogates of RVEF: fraction area change in 2D-mode, tricuspid annular plane systolic excursion (TAPSE) in M-mode, and maximal velocity of the systolic S' wave using tissue Doppler imaging.

Real-time three-dimensional (3D) echocardiography now enables accurate on-line measurement of RV volume and provides at the bedside the non-invasive assessment of RVEF. 3D transthoracic echocardiography (TTE) has been validated to measure RV volume and RVEF compared to MRI which is the gold standard. However, 3D transesophageal echocardiography (TEE) has not yet been validated in this specific clinical setting, while 2D TEE is frequently used in ICU in ventilated and sedated patients. Accordingly, the diagnostic ability of 3D echocardiography to quantify RV systolic function in ICU patients with RVF of any origin is currently unknown.

location_facility:
CHU de TOURS
Limoges university hospital


title: French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis

acronym: Val-SpA

summary:
The aim is to do a French linguistic validation of three questionnaires used in axial Spondyloarthritis (BASFI, BAS-G, Dougados Functional Index).

In order to validate the questionnaires, a prospective, qualitative, observational and monocentric study will be conducted.

lead_sponsor: University Hospital, Grenoble

location_facility:
Chu Grenoble Alpes
CHU Grenoble Alpes


title: Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating - Predict4All

summary:
The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user.

The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist).

Adapting the prediction to user errors should also allow it to be more relevant throughout the text input. This software efficiency must increase text input speed, Reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
CMRRF Kerpape
Raymond Poincaré hospital


title: Evaluation of the Plasmatic and Urinary Neutrophil Gelatinase - Associated Lipocalin as a Predictive Marker of Renal Injury in Children With Febrile Urinary Infection

acronym: NGAL

summary:
Urinary infections in children is very common. Delay in the diagnosis may be followed by complications.

Pyelonephritis is a febrile urinary infection with a renal injury. In local experience, about 30-40% of the children don't have an inflammatory syndrome or echographical abnormalities. Do they really have a renal injury ? In fact, only the scintigraphy or the Magnetic Resonance Imaging (MRI) may show these lesions, but are done only in specific cases (diagnosis of uropathy or nephropathy). Recent studies have shown that plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) is associated traumatic or inflammatory renal lesions. But the plasmatic NGAL cutoff is fluctuant depending on the cohorts and gold standards. The main goal is to evaluate a new methodology of dosing NGAL, (immuno-dosage turbidimetric dosage). The investigators suppose that plasmatic NGAL protein will detect renal injury, which would be confirmed by MRI.

The aim of this study is to evaluate the area under the curve (AUC) of plasmatic NGAL protein with an automatised method, for the detection of renal injury. This would be confirmed by reno vesical MRI, in children over 2 years old with febrile urinary infections

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval


title: Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks

acronym: R-IMPAC

summary: Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Procedure


title: Comparison of Two Exercise Training Modalities on Left Myocardial Regional Function After MI (Myocardial Infarction) Evaluated by 2D Strain Ultrasound - a Randomized Controlled Bicentric Study

acronym: STRAICT

summary: Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown undeniable benefits in decreasing the overall mortality rate (13-26%), cardiovascular mortality (26-36%) and morbidity, by controlling cardiovascular risk factors and improving tolerance to effort and consequently improving the quality of life. Since the integration of physical exercise into the rehabilitation programs of patients suffering from coronary disease in the mid-90s, and throughout the following decade, the exercise training program has mainly relied on moderately intense continuous exercises (CONT) the aim of which is to improve the aerobic capacity. These efforts typically consist of performing a submaximal exercise with an intensity of 50 to 80% of the maximum capacity for effort (established according to studies depending on the maximum or reserve heart rate or even peak power, measured when performing a first test, then a progressive and maximum test), and a constant duration (about 20 to 60 minutes). In the 2000s, under the aegis of Scandinavian teams, the intermittent mode (IT) appeared, characterized by alternating high intensity efforts of a short duration with active recuperation phases (Rognmo et al., 2004). Superiority of the IT mode over the CONT mode is generally observed on aerobic capacity for effort, usually gauged via the maximal oxygen consumption peak measured during a graded and maximum effort test. An important methodological bias in the comparison of the two modalities, within meta-analyses or even in the same randomized controlled trial, is the absence of control/pairing on the overall volume of training. At the present time, and to the best of our knowledge, there have been no studies to compare the effects of CONT versus IT modes on the systolic or diastolic function of the myocardial region by 2D-strain following myocardial infarction. The aim of our study was to compare the outcomes of 2D strain scans upon inclusion and after 8 weeks of cardiovascular physiotherapy for 2 groups of patients benefiting from a CONT or IT program.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Clinique Lavarin, Centre de Rééducation Cardiaque,1 Rue Mère Térésa,


title: Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 3 Months).

acronym: SPIRIT

summary:
The SPIRIT study is interventional, national, prospective, open, bicentric each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting a non-traumatic acute-subacute hemiplegia. The primary endpoint is defined by the patient's ability to perform the 10 MWT with the Atalante system.

The study will include 16 patients and takes place in two french rehabilitation centers.

lead_sponsor: Wandercraft

location_facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape


title: Impact of the Transpulmonary Pressure on Right Ventricle Function in Acute Respiratory Distress Syndrome

acronym: VD-SDRA

summary:
Pulmonary distension induced by mechanical ventilation physiologically alters right ventricle pre and after-load, hence might lead to right ventricle failure. The hypothesis is that in Acute Respiratory Distress Syndrome, the occurence of a right ventricle failure under lung protective ventilation might :

i) be correlated to the transpulmonary pressure level, ii) lead to global heart failure, iii) and extremely result in poor outcome and death.

The primary objective is to test the impact of transpulmonary pressure on right ventricular function in Acute Respiratory Distress Syndrome in adults and children.

Secondary objectives are :

i) to compare thresholds of transpulmonary pressure associated with right ventricle failure between children and adults.

ii) to assess if there is an association between transpulmonary pressure and morbidity and mortality.

- For pediatric patients, a specific monitoring with electrical impedance tomography (EIT) will allow:

To assess if the transpulmonary pressure is associated with the level of regional pulmonary overdistention (or collapse) on electrical impedance tomography.(EIT)
To assess if there is an association between the occurrence of right ventricular failure, and distribution of ventilation on EIT.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Necker-Enfants Malades
Hôpital Ambroise Paré


title: Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

acronym: EVA

summary:
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized.

Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse

location_facility: Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot


title: Prospective Observational Study Studying the Influence of the Presence of Liver Cirrhosis During Chemotherapy for ENT Cancer, Upper Digestive Tract Cancer or Colorectal Cancer.

acronym: CHIMIOSE

summary:
Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs.

Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies.

The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy.

The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer.

Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients' outcomes with a control group of matched non-cirrhotic patients.

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Claude Huriez, CHU
Centre Oscar Lambret


title: Catastrophism in Chronic Inflammatory Rheumatism

acronym: CRIC

summary:
Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).

Recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.

In chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.

location_facility:
CHU de Montpellier
CHU de Nîmes


title: From Immune System Damage to Podocyte Cell Damage: Prospective Database and Biological Collection of Patients (Children and Adults) With Minimal Glomerular Injury Nephrotic Syndrome (MGLS) and Primary Segmental and Focal Hyalinosis (HSFP)

acronym: BiobankSNI

summary:
Idiopathic Nephrotic Syndrome (INS) is a kidney disease characterized by massive proteinuria and hypoalbuminemia. It includes two anatomopathological entities: nephrotic syndrome with minimal glomerular lesions (SNLGM) and primary segmental and focal hyalinosis (PHF). Renal biopsy reveals a fusion of the feet of the podocytes without inflammatory lesions or deposits of immune complexes. Clinical and experimental observations strongly suggest that the immune system and podocyte dysfunction are the two facets of the disease. There are currently no clinical or biological markers to predict the diagnosis of corticosteroid sensitivity, corticosteroid dependence, or risk of recurrence of kidney disease after kidney transplantation. To our knowledge, no prospective studies have been designed to study both immune system alterations and podocyte damage as well as genetic predisposition variants in NIS. Therefore, the use of steroids/immunosuppressive agents is purely empirical with a multitude of side effects.

The objective is to identify and test new therapeutic targets rather than conducting new trials with existing treatments, using either drug candidates or molecules selected by high throughput screening of libraries of repositioning molecules using an appropriate read-out. The biobank may also be used to analyze the effects of conventional treatments on identified new biomarkers. We expect the project to produce original and patentable results with subsequent valuation. Patentability will be anticipated before any publication on the subject. The patent and valorization cells of hospitals, INSERM and Universities will be involved in the results as soon as they are obtained.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
APHP
Nice Hospital


title: Placenta Accreta : Contrast-enhanced Ultrasound Analysis in High Risk Population

summary:
Abnormally invasive placenta (AIP) is defined as an abnormal placental attachment of a part or the entire chorionic plate with penetration of chorionic villi in the myometrium and absence of the decidua basalis. This anomaly is associated with significant maternal morbidity and mortality as it may result in severe haemorrhage during the post-partum. It has been demonstrated that prenatal diagnosis of AIP is essential to reduce maternal morbidity. In a recent study of Chantraine F. et al. prenatal diagnosis of AIP leads to better outcomes, due to fewer emergency operations and less mass transfusions. Currently, the diagnosis of AIP is based on a combination of conventional B-mode ultrasound and MRI. However, prenatal diagnosis of AIP remains challenging and recent reports demonstrated it is achieved in only thirds of cases.

Contrast enhanced ultrasound (CEUS) is a non-invasive technique based on the detection by ultrasound (US) of gas-filled microbubbles used as perfusion tracers. Intravascular rheological properties of these bubbles are similar to those of red blood cells and they remain entirely within the intravascular space. Previous studies have demonstrated that microbubbles do not transfer into fetal circulation. CEUS has been used for years in many US imaging applications (e.g. liver, kidneys and breast). In obstetrics, despite not yet approved for clinical use, CEUS offers the opportunity to analyze anatomical placental landmarks, improving the contrast between placenta and myometrium. In addition, quantification parameters related to the contrast enhancement have been proposed as objective indicators to estimate blood perfusion rates in the placental intervillous space.

The main objective of this study is to provide pre-clinical evaluation of CEUS for the diagnosis of AIP and to try to determine if AIP are characterised by differences in intervillous blood rheological properties. Conventional CEUS parameters will be: rise time, peak enhancement, wash-in rate, mean transit time and wash-in area under the curve.

As this study is a pre-clinical evaluation, sample size calculation remains subjective and imprecise. For this reason, a sample size of 100 pregnant women to be included in this prospective study has been decided.

The potential impact of this study will be to propose a more reliable tool with both improved sensibility and specificity compared to the combination US/MRI and therefore to reduce the maternal worldwide burden of AIP.

lead_sponsor: University Hospital, Tours

location_facility:
University Hospital of Tours
CHU La Millétrie


acronym: PAC CEF

location_facility:
CHU de Nîmes
Centre Hospitalier Lyon Sud,

title: A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia

summary:
The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.

The secondary aims are :

A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.

B- To define the optimal dose regimen for ceftobiprole in this population.

C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).

D- To evaluate the clinical evolution.

E- To evaluate the clinical and biological tolerance.


title: Predictive Factors of the Autonomy Level Change Related to Memory Disorders

acronym: MEMORA

summary: The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.

ReferenceCitation: Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.

family: Dauphinot

full_name: Virginie Dauphinot

given: Virginie

family: Moutet

full_name: Claire Moutet

given: Claire

family: Rouch

full_name: Isabelle Rouch

given: Isabelle

family: Verdurand

full_name: Mathieu Verdurand

given: Mathieu

family: Mouchoux

full_name: Christelle Mouchoux

family: Delphin-Combe

full_name: Floriane Delphin-Combe

given: Floriane

family: Gaujard

full_name: Sylvain Gaujard

given: Sylvain

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

journal_name: BMC Geriatrics

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

location_facility: Hospices Civils de Lyon - Hôpital des Charpennes


title: Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

acronym: MGM-Eval

summary: Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Institut Hospitalier Franco-Britannique


title: Diagnostic Performance of Optical Biopsy by Cellvizio® in Gynecological Surgery

acronym: GYNECOPTIC

summary:
Optical biopsy is a new technology that generates a real-time, cell-based, high-resolution view and analysis of tissues. Observation is instantaneous and non-invasive. This allows reliable and fast diagnosis which facilitates decision making as well as patient management.

The investigator have already conducted a feasibility study on the use of this new technology to evaluate ovarian and tubal pre-cancerous lesions in laparoscopy. In this new study, he wants to continue investigations, expand its use to other gynecological pathologies, and demonstrate the benefit of such a non-invasive technology in gynecology on the one hand in the diagnosis of lesions but also to appreciate the margins as accurately as possible surgical excision of tumors and / or endometriosis lesions.

The investigator have set up a prospective monocentric descriptive study. The hypothesis is that optical biopsy by Cellvizio® allows to observe in real time microscopically tissues and to characterize them in the field of gynecological surgery

location_facility: Service de Gynécologie, HFME, Hospices Civils de Lyon

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon


title: ScleroBiotique: Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

acronym: ScleroBiotique

summary: Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hôpital Européen Marseille
Hôpital Euroépen Marseille


title: HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

acronym: HYPIC

summary: Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.

lead_sponsor: Rennes University Hospital

location_facility:
Rennes University Hospital
Saint-Brieuc Hospital


title: Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections

summary: The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified

ReferenceCitation: Alexandre K, Réveillon-Istin M, Fabre R, Delbos V, Etienne M, Pestel-Caron M, Dahyot S, Caron F. Temocillin against Enterobacteriaceae isolates from community-acquired urinary tract infections: low rate of resistance and good accuracy of routine susceptibility testing methods. J Antimicrob Chemother. 2018 Jul 1;73(7):1848-1853. doi: 10.1093/jac/dky101.

name: Infectious Diseases Department, Rouen University Hospital, Rouen, France

name: EA 2656 (Groupe de Recherche sur l’Adaptation Microbienne 2.0), Institute for Research and Innovation in Biomedicine, Normandie Univ, Unirouen, Rouen, France

family: Alexandre

full_name: K Alexandre

given: K

family: Réveillon-Istin

full_name: M Réveillon-Istin

given: M

name: Laboratoire de Biologie Médicale Régional de Normandie, Elbeuf, France

family: Fabre

full_name: R Fabre

given: R

family: Delbos

full_name: V Delbos

given: V

family: Etienne

full_name: M Etienne

family: Pestel-Caron

full_name: M Pestel-Caron

family: Dahyot

full_name: S Dahyot

given: S

family: Caron

full_name: F Caron

given: F

journal_name: Journal of Antimicrobial Chemotherapy

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Rouen

location_facility:
Lbmr de Normandie
Rouen University Hospital


title: Sedation in Palliative Care Management Context for Cancer Patients

summary: This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.

ReferenceCitation: Vieille M, Dany L, Coz PL, Avon S, Keraval C, Salas S, Bernard C. Perception, Beliefs, and Attitudes Regarding Sedation Practices among Palliative Care Nurses and Physicians: A Qualitative Study. Palliat Med Rep. 2021 May 24;2(1):160-167. doi: 10.1089/pmr.2021.0022. eCollection 2021.

name: Aix-Marseille Université, LPS, Aix-en-Provence, France.

family: Vieille

full_name: Margaux Vieille

given: Margaux

name: APHM, Timone, Service d'Oncologie Médicale, Marseille, France.

family: Dany

full_name: Lionel Dany

given: Lionel

name: Aix Marseille Université, CNRS, EFS, ADES, Marseille, France.

family: Coz

full_name: Pierre Le Coz

given: Pierre Le

family: Avon

full_name: Sophie Avon

given: Sophie

family: Keraval

full_name: Charlotte Keraval

given: Charlotte

name: Aix Marseille Université, CRO2, Marseille, France.

family: Salas

full_name: Sébastien Salas

given: Sébastien

name: Clinique Sainte Elisabeth, Marseille, France.

family: Bernard

full_name: Cécile Bernard

given: Cécile

currency_apc_doaj: USD

journal_name: Palliative Medicine Reports

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

repository_normalized: HAL

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille