title: A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

summary:
The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.

Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.

status: Terminated

lead_sponsor: Poitiers University Hospital


acronym: RiskofADR

summary:
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.

Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia at the University Hospital of Reims, France.

Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Kanagaratnam L, Dramé M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R. Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit. Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296. doi: 10.1016/j.jagp.2016.07.002. Epub 2016 Sep 1.

lead_sponsor: CHU de Reims

lead_sponsor_type: academique

status_simplified: Completed


title: Habituation's Mechanisms in Preterm and Term Infants. Behavioral Evaluation: APIB (Assessment of Preterm Infant's Behavior). Assessment of the Cortical and Vegetative Responses

acronym: HABIPREMA

summary: Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light…). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest

intervention_type: Behavioral

status_simplified: Unknown


title: Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)

acronym: BConvinced

summary:
The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.

162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire Hautepierre

location_facility: Centre Hospitalier Universitaire Potcaillou

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Les Etablissements Hospitaliers du Bessin

location_facility: Centre Hospitalier Universitaire La Milétrie

intervention_type: Drug


title: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria: Pilot Study

acronym: POP-UP

summary:
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.

Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.

primary_purpose: Screening

ipd_sharing: No

lead_sponsor: Hopital Foch

intervention_type: Other


title: Prospective and Retrospective Neoadjuvant Breast Cancer Database

acronym: NEOADJ

summary:
The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way.

This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

status: Recruiting

lead_sponsor: Centre Georges Francois Leclerc

location_facility: Methodology, Biostatistics and Data Management Unit

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Phase I Multicenter Double-blind Placebo Controlled Dose Escalation Trial of an Adjuvanted Anti-CD40 mAb Fused to Env GP140 HIV Clade C ZM-96 (CD40.HIVRI.Env) Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Participants

summary:
Multicenter double-blind placebo controlled phase I dose-escalation trial that will be conducted in France and Switzerland to evaluate different dose levels of CD40.HIVRI.Env (adjuvanted with Hiltonol) alone and in co-administration with DNA-HIV-PT123.

A total of 72 eligible healthy participants will be recruited into 6 groups. Within each group, participants will be randomized in a double blind manner to active intervention or placebo in a 5:1 ratio. Enrolment into a given group (other than group "Solo 0.3") will open sequentially depending on the " go-criterion " based on the safety data of the preceding group(s).

The primary objective is to assess the safety of three dose levels of CD40.HIVRI.Env (0.3; 1; 3 mg) adjuvanted with Poly-ICLC (Hiltonol®), alone and in combination with DNA-HIV-PT123, administered at weeks 0, 4 and 24 in healthy participants.

Secondary objectives are to assess the capacity of poly-ICLC-adjuvanted CD40.HIVRI.Env alone and in combination with DNA-HIV-PT123 to elicit immune responses against HIV (immunogenicity):

Humoral (antibody) responses ;
B-cell responses ;
T-cell responses.

lead_sponsor: ANRS, Emerging Infectious Diseases

intervention_type: Biological


title: Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion

acronym: INTEM

summary:
Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

lead_sponsor: Rennes University Hospital

location_facility:
Nantes University Hospital
Tours University Hospital
Rennes University Hospital

intervention_type: Device


title: The DNA and Cell Bank of IFR of Neurosciences: Clinical and Genetic Study of Parkinson's Disease and Epilepsies

summary:
The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been running for the last 15 years at the Institut National de la Santé Et de la Recherche Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the support of research projects in genetics for neurological and psychiatric disorders. The cohorts established have led to discoveries in monogenic disorders, such as cerebellar ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson's and Alzheimer's disease, Charcot-Marie-Tooth disease and related entities. The research projects based on the study of the genetic bases in Parkinson's disease and epilepsies are especially developed for this grant.

Concerning Parkinson's disease, the project is based on the extension of the existing cohort throughout the French Parkinson's Disease Study Group network. Concerning epilepsies, this project is the occasion to build this network with the constitution of a new cohort.

The specific aims of the scientific projects are the following for Parkinson's disease:

to evaluate the frequency, the nature and the phenotype associated with parkin mutations in familial or sporadic forms of the disease, according to the age at onset, and
to identify the genetic susceptibility factors in Parkinson's disease with the study of affected sibpairs and with case/controls association studies.

For epilepsies, the aims are:

to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and GABR2 gene mutations in familial or sporadic forms of the affection associated with febrile seizures, and
to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these forms of epilepsies.

ReferenceType: result

ReferenceCitation: Ibáñez P, Bonnet AM, Débarges B, Lohmann E, Tison F, Pollak P, Agid Y, Dürr A, Brice A. Causal relation between alpha-synuclein gene duplication and familial Parkinson's disease. Lancet. 2004 Sep 25-Oct 1;364(9440):1169-71.

ReferenceCitation: Lesage S, Leutenegger AL, Ibanez P, Janin S, Lohmann E, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. LRRK2 haplotype analyses in European and North African families with Parkinson disease: a common founder for the G2019S mutation dating from the 13th century. Am J Hum Genet. 2005 Aug;77(2):330-2.

ReferenceCitation: Lesage S, Ibanez P, Lohmann E, Pollak P, Tison F, Tazir M, Leutenegger AL, Guimaraes J, Bonnet AM, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. G2019S LRRK2 mutation in French and North African families with Parkinson's disease. Ann Neurol. 2005 Nov;58(5):784-7.

ReferenceCitation: Lesage S, Leutenegger AL, Brice A. [LRRK2: a gene belonging to the ROCO family is implicated in the Parkinson's disease]. Med Sci (Paris). 2005 Dec;21(12):1015-7. French.

ReferenceCitation: Ibáñez P, Lesage S, Lohmann E, Thobois S, De Michele G, Borg M, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. Mutational analysis of the PINK1 gene in early-onset parkinsonism in Europe and North Africa. Brain. 2006 Mar;129(Pt 3):686-94. Epub 2006 Jan 9.

ReferenceCitation: Lesage S, Dürr A, Tazir M, Lohmann E, Leutenegger AL, Janin S, Pollak P, Brice A; French Parkinson's Disease Genetics Study Group. LRRK2 G2019S as a cause of Parkinson's disease in North African Arabs. N Engl J Med. 2006 Jan 26;354(4):422-3.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Pitié-Salpêtrière Hospital - Centre of Clinical Investigations


title: Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation

acronym: StimAOD

summary:
Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption > 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.

lead_sponsor: Institut Necker Enfants Malades


title: Assessement of Capacity to Consent in Depressed Patients

summary:
Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory.

Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode.

This is a Social and Human Sciences study which does not aim to modify the usual management of patients.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


type: Registry Identifier

title: Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme

acronym: CERESMARCHE

summary: In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. The specific role of these structures in both the capacity to go forward (locomotion) and stand upright (balance), but also in the different phases of the gait initiation process, are not known, however. In this study,the investigators aimed to assess the specific role of both the supplementary motor area (SMA) and the cerebellum in postural control during the initiation of gait. For this purpose, the investigators plan to study the gait initiation in 20 healthy subjects before and after functional inactivation (using inhibitory repetitive transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic and electromyographic parameters of the gait initiation will be recorded using a force platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG electrodes.

primary_purpose: Basic Science


title: Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

summary:
Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.

The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Sans A, Bailly L, Anty R, Sielezenef I, Gugenheim J, Tran A, Gual P, Iannelli A. Baseline Anthropometric and Metabolic Parameters Correlate with Weight Loss in Women 1-Year After Laparoscopic Roux-En-Y Gastric Bypass. Obes Surg. 2017 Nov;27(11):2940-2949. doi: 10.1007/s11695-017-2720-8. Erratum in: Obes Surg. 2017 Jul 5;:.

family: Sans

full_name: Arnaud Sans

given: Arnaud

sequence: first

family: Bailly

full_name: Laurent Bailly

given: Laurent

sequence: additional

family: Anty

full_name: Rodolphe Anty

given: Rodolphe

family: Sielezenef

full_name: Igor Sielezenef

given: Igor

family: Gugenheim

full_name: Jean Gugenheim

given: Jean

family: Tran

full_name: Albert Tran

given: Albert

family: Gual

full_name: Philippe Gual

given: Philippe

family: Iannelli

full_name: Antonio Iannelli

given: Antonio

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Obesity Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service d'Hépato-Gastroentérologie - Hôpital de l'Archet


title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

acronym: ELPAS

summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.

ReferenceCitation: Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. doi: 10.1001/archpediatrics.2007.2.

family: Paineau

full_name: Damien L. Paineau

given: Damien L.

family: Beaufils

full_name: François Beaufils

given: François

family: Boulier

full_name: Alain Boulier

given: Alain

family: Cassuto

full_name: Dominique-Adèle Cassuto

given: Dominique-Adèle

family: Chwalow

full_name: Judith Chwalow

given: Judith

family: Combris

full_name: Pierre Combris

given: Pierre

family: Couet

full_name: Charles Couet

given: Charles

family: Jouret

full_name: Béatrice Jouret

given: Béatrice

family: Lafay

full_name: Lionel Lafay

given: Lionel

family: Laville

full_name: Martine Laville

given: Martine

family: Mahe

full_name: Sylvain Mahe

given: Sylvain

family: Ricour

full_name: Claude Ricour

given: Claude

family: Romon

full_name: Monique Romon

given: Monique

family: Simon

full_name: Chantal Simon

given: Chantal

family: Tauber

full_name: Maïté Tauber

given: Maïté

family: Valensi

full_name: Paul Valensi

given: Paul

family: Chapalain

full_name: Véronique Chapalain

given: Véronique

family: Zourabichvili

full_name: Othar Zourabichvili

given: Othar

family: Bornet

full_name: Francis Bornet

given: Francis

bso_classification: Biology (fond.)

journal_name: Archives of Pediatrics & Adolescent Medicine

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control

lead_sponsor: Centre d'Etudes et de Documentation du Sucre


title: Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

acronym: FLOWERS

summary:
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.

In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.

primary_purpose: Health Services Research

ReferenceCitation: Nolan JP, Deakin CD, Soar J, Böttiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. Review.

ReferenceCitation: Eftestøl T, Sunde K, Steen PA. Effects of interrupting precordial compressions on the calculated probability of defibrillation success during out-of-hospital cardiac arrest. Circulation. 2002 May 14;105(19):2270-3.

ReferenceCitation: Eftestøl T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. Epub 2004 Jun 21.

ReferenceCitation: Adrie C, Cariou A, Mourvillier B, Laurent I, Dabbane H, Hantala F, Rhaoui A, Thuong M, Monchi M. Predicting survival with good neurological recovery at hospital admission after successful resuscitation of out-of-hospital cardiac arrest: the OHCA score. Eur Heart J. 2006 Dec;27(23):2840-5. Epub 2006 Nov 2. Erratum in: Eur Heart J. 2007 Mar;28(6):774.

ReferenceCitation: Edelson DP, Abella BS, Kramer-Johansen J, Wik L, Myklebust H, Barry AM, Merchant RM, Hoek TL, Steen PA, Becker LB. Effects of compression depth and pre-shock pauses predict defibrillation failure during cardiac arrest. Resuscitation. 2006 Nov;71(2):137-45. Epub 2006 Sep 18.

ReferenceCitation: Abella BS, Sandbo N, Vassilatos P, Alvarado JP, O'Hearn N, Wigder HN, Hoffman P, Tynus K, Vanden Hoek TL, Becker LB. Chest compression rates during cardiopulmonary resuscitation are suboptimal: a prospective study during in-hospital cardiac arrest. Circulation. 2005 Feb 1;111(4):428-34.

ReferenceCitation: Wiese CH, Bahr J, Bergmann A, Bergmann I, Bartels U, Graf BM. [Reduction in no flow time using a laryngeal tube: comparison to bag-mask ventilation]. Anaesthesist. 2008 Jun;57(6):589-96. doi: 10.1007/s00101-008-1358-2. German.

ReferenceCitation: Odegaard S, Pillgram M, Berg NE, Olasveengen T, Kramer-Johansen J. Time used for ventilation in two-rescuer CPR with a bag-valve-mask device during out-of-hospital cardiac arrest. Resuscitation. 2008 Apr;77(1):57-62. doi: 10.1016/j.resuscitation.2007.11.005.

ReferenceCitation: Wik L, Kramer-Johansen J, Myklebust H, Sørebø H, Svensson L, Fellows B, Steen PA. Quality of cardiopulmonary resuscitation during out-of-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):299-304.

ReferenceCitation: Abella BS, Alvarado JP, Myklebust H, Edelson DP, Barry A, O'Hearn N, Vanden Hoek TL, Becker LB. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):305-10.

ReferenceCitation: Valenzuela TD, Kern KB, Clark LL, Berg RA, Berg MD, Berg DD, Hilwig RW, Otto CW, Newburn D, Ewy GA. Interruptions of chest compressions during emergency medical systems resuscitation. Circulation. 2005 Aug 30;112(9):1259-65. Epub 2005 Aug 22.

ReferenceCitation: Kern KB, Hilwig RW, Berg RA, Ewy GA. Efficacy of chest compression-only BLS CPR in the presence of an occluded airway. Resuscitation. 1998 Dec;39(3):179-88.

ReferenceCitation: Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70.

ReferenceCitation: Yu T, Weil MH, Tang W, Sun S, Klouche K, Povoas H, Bisera J. Adverse outcomes of interrupted precordial compression during automated defibrillation. Circulation. 2002 Jul 16;106(3):368-72.

ReferenceCitation: Bowman FP, Menegazzi JJ, Check BD, Duckett TM. Lower esophageal sphincter pressure during prolonged cardiac arrest and resuscitation. Ann Emerg Med. 1995 Aug;26(2):216-9.

ReferenceCitation: Gabrielli A, Wenzel V, Layon AJ, von Goedecke A, Verne NG, Idris AH. Lower esophageal sphincter pressure measurement during cardiac arrest in humans: potential implications for ventilation of the unprotected airway. Anesthesiology. 2005 Oct;103(4):897-9.

ReferenceCitation: Wenzel V, Idris AH, Banner MJ, Kubilis PS, Williams JL Jr. Influence of tidal volume on the distribution of gas between the lungs and stomach in the nonintubated patient receiving positive-pressure ventilation. Crit Care Med. 1998 Feb;26(2):364-8.

ReferenceCitation: Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8.

ReferenceCitation: Lawes EG, Baskett PJ. Pulmonary aspiration during unsuccessful cardiopulmonary resuscitation. Intensive Care Med. 1987;13(6):379-82.

ReferenceCitation: Sayre MR, Sakles JC, Mistler AF, Evans JL, Kramer AT, Pancioli AM. Field trial of endotracheal intubation by basic EMTs. Ann Emerg Med. 1998 Feb;31(2):228-33.

ReferenceCitation: Bradley JS, Billows GL, Olinger ML, Boha SP, Cordell WH, Nelson DR. Prehospital oral endotracheal intubation by rural basic emergency medical technicians. Ann Emerg Med. 1998 Jul;32(1):26-32.

ReferenceCitation: Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med. 2001 Jan;37(1):32-7.

ReferenceCitation: Dörges V, Wenzel V, Schumann T, Neubert E, Ocker H, Gerlach K. Intubating laryngeal mask airway, laryngeal tube, 1100 ml self-inflating bag-alternatives for basic life support? Resuscitation. 2001 Nov;51(2):185-91.

ReferenceCitation: Ocker H, Wenzel V, Schmucker P, Steinfath M, Dörges V. A comparison of the laryngeal tube with the laryngeal mask airway during routine surgical procedures. Anesth Analg. 2002 Oct;95(4):1094-7, table of contents.

ReferenceCitation: Bein B, Carstensen S, Gleim M, Claus L, Tonner PH, Steinfath M, Scholz J, Dörges V. A comparison of the proseal laryngeal mask airway, the laryngeal tube S and the oesophageal-tracheal combitube during routine surgical procedures. Eur J Anaesthesiol. 2005 May;22(5):341-6.

ReferenceCitation: Genzwuerker HV, Finteis T, Slabschi D, Groeschel J, Ellinger K. Assessment of the use of the laryngeal tube for cardiopulmonary resuscitation in a manikin. Resuscitation. 2001 Dec;51(3):291-6.

ReferenceCitation: Figueredo E, Martínez M, Pintanel T. A comparison of the ProSeal laryngeal mask and the laryngeal tube in spontaneously breathing anesthetized patients. Anesth Analg. 2003 Feb;96(2):600-5, table of contents.

ReferenceCitation: Mihai R, Knottenbelt G, Cook TM. Evaluation of the revised laryngeal tube suction: the laryngeal tube suction II in 100 patients. Br J Anaesth. 2007 Nov;99(5):734-9. Epub 2007 Sep 14.

ReferenceCitation: Genzwuerker HV, Dhonau S, Ellinger K. Use of the laryngeal tube for out-of-hospital resuscitation. Resuscitation. 2002 Feb;52(2):221-4.

ReferenceCitation: Kette F, Reffo I, Giordani G, Buzzi F, Borean V, Cimarosti R, Codiglia A, Hattinger C, Mongiat A, Tararan S. The use of laryngeal tube by nurses in out-of-hospital emergencies: preliminary experience. Resuscitation. 2005 Jul;66(1):21-5.

ReferenceCitation: Dörges V, Ocker H, Wenzel V, Sauer C, Schmucker P. Emergency airway management by non-anaesthesia house officers--a comparison of three strategies. Emerg Med J. 2001 Mar;18(2):90-4.

ReferenceCitation: Dörges V, Wenzel V, Neubert E, Schmucker P. Emergency airway management by intensive care unit nurses with the intubating laryngeal mask airway and the laryngeal tube. Crit Care. 2000;4(6):369-76. Epub 2000 Oct 13.

ReferenceCitation: Asai T, Hidaka I, Kawachi S. Efficacy of the laryngeal tube by inexperienced personnel. Resuscitation. 2002 Nov;55(2):171-5.

ReferenceCitation: Asai T, Kawachi S. Use of the laryngeal tube by paramedic staff. Anaesthesia. 2004 Apr;59(4):408-9.

ReferenceCitation: Kurola J, Harve H, Kettunen T, Laakso JP, Gorski J, Paakkonen H, Silfvast T. Airway management in cardiac arrest--comparison of the laryngeal tube, tracheal intubation and bag-valve mask ventilation in emergency medical training. Resuscitation. 2004 May;61(2):149-53.

ReferenceCitation: Kurola JO, Turunen MJ, Laakso JP, Gorski JT, Paakkonen HJ, Silfvast TO. A comparison of the laryngeal tube and bag-valve mask ventilation by emergency medical technicians: a feasibility study in anesthetized patients. Anesth Analg. 2005 Nov;101(5):1477-1481. doi: 10.1213/01.ANE.0000182330.54814.70.

ReferenceCitation: Wiese CH, Bartels U, Schultens A, Steffen T, Torney A, Bahr J, Graf BM. Influence of airway management strategy on "no-flow-time" during an "advanced life support course" for intensive care nurses - a single rescuer resuscitation manikin study. BMC Emerg Med. 2008 Apr 10;8:4. doi: 10.1186/1471-227X-8-4.

ReferenceCitation: Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Bragança C, Billères X, Clotteau-Lambert MP, Fuster P, Thiercelin D, Debaty G, Ricard-Hibon A, Roux P, Espesson C, Querellou E, Ducros L, Ecollan P, Halbout L, Savary D, Guillaumée F, Maupoint R, Capelle P, Bracq C, Dreyfus P, Nouguier P, Gache A, Meurisse C, Boulanger B, Lae C, Metzger J, Raphael V, Beruben A, Wenzel V, Guinhouya C, Vilhelm C, Marret E. Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. N Engl J Med. 2008 Jul 3;359(1):21-30. doi: 10.1056/NEJMoa0706873.

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

given: Pierre-Yves

family: David

full_name: Jean-Stéphane David

given: Jean-Stéphane

family: Chanzy

full_name: Eric Chanzy

given: Eric

family: Hubert

full_name: Hervé Hubert

given: Hervé

family: Dubien

full_name: Pierre-Yves Dubien

family: Mauriaucourt

full_name: Patrick Mauriaucourt

given: Patrick

family: Bragança

full_name: Coralie Bragança

given: Coralie

family: Billères

full_name: Xavier Billères

given: Xavier

family: Clotteau-Lambert

full_name: Marie-Paule Clotteau-Lambert

given: Marie-Paule

family: Fuster

full_name: Patrick Fuster

family: Thiercelin

full_name: Didier Thiercelin

given: Didier

family: Debaty

full_name: Guillaume Debaty

given: Guillaume

family: Ricard-Hibon

full_name: Agnès Ricard-Hibon

given: Agnès

family: Roux

full_name: Patrick Roux

title: Vasopressin and Epinephrine vs. Epinephrine Alone in Cardiopulmonary Resuscitation

ReferenceCitation: Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, Carli P. A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group. N Engl J Med. 1998 Nov 26;339(22):1595-601.

ReferenceCitation: Asai T, Moriyama S, Nishita Y, Kawachi S. Use of the laryngeal tube during cardiopulmonary resuscitation by paramedical staff. Anaesthesia. 2003 Apr;58(4):393-4.

ReferenceCitation: Asai T, Shingu K. The laryngeal tube. Br J Anaesth. 2005 Dec;95(6):729-36. Review.

ReferenceCitation: Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett P, Becker L, Bossaert L, Delooz H, Dick W, Eisenberg M, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. Task Force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Ann Emerg Med. 1991 Aug;20(8):861-74. Review.

ReferenceCitation: Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M; ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med. 2005 Mar;31(3):476-9. Epub 2005 Feb 15.


summary: The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a relatively invasive endoscopic examination, often badly tolerated, and which, in France, is carried out in 50% of the cases under general anaesthesia. The development of a Capsule Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless exploration of the oesophagus, without infectious risk.The aim of this study is to validate the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these patients, after being informed and to have given their signed assent, will initially have an exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy then by the upper endoscopy will be analyzed by investigators different. This study should make it possible to evaluate the parameters of specificity, sensitivity and predictive values of Esophageal Capsule Endoscopy in this indication.

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital


title: The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

summary: The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.

ReferenceCitation: Lanternier F, Tubach F, Ravaud P, Salmon D, Dellamonica P, Bretagne S, Couret M, Bouvard B, Debandt M, Gueit I, Gendre JP, Leone J, Nicolas N, Che D, Mariette X, Lortholary O; Research Axed on Tolerance of Biotherapies Group. Incidence and risk factors of Legionella pneumophila pneumonia during anti-tumor necrosis factor therapy: a prospective French study. Chest. 2013 Sep;144(3):990-998. doi: 10.1378/chest.12-2820.

family: Lanternier

full_name: Fanny Lanternier

given: Fanny

family: Tubach

full_name: Florence Tubach

given: Florence

family: Ravaud

full_name: Philppe Ravaud

given: Philppe

family: Salmon

full_name: Dominique Salmon

given: Dominique

family: Dellamonica

full_name: Pierre Dellamonica

given: Pierre

family: Bretagne

full_name: Stephane Bretagne

given: Stephane

family: Couret

full_name: Marie Couret

given: Marie

family: Bouvard

full_name: Beatrice Bouvard

given: Beatrice

family: Debandt

full_name: Michel Debandt

given: Michel

family: Gueit

full_name: Isabelle Gueit

given: Isabelle

family: Gendre

full_name: Jean-Pierre Gendre

given: Jean-Pierre

family: Leone

full_name: Jean Leone

given: Jean

family: Nicolas

full_name: Nathalie Nicolas

given: Nathalie

family: Che

full_name: Dider Che

given: Dider

family: Mariette

full_name: Xavier Mariette

family: Lortholary

full_name: Olivier Lortholary

given: Olivier

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Incidence and Risk Factors of Legionella pneumophila Pneumonia During Anti-Tumor Necrosis Factor Therapy

ReferenceCitation: Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Bréban M, Pallot-Prades B, Pouplin S, Sacchi A, Chichemanian RM, Bretagne S, Emilie D, Lemann M, Lortholary O, Mariette X; Research Axed on Tolerance of Biotherapies Group. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum. 2009 Jul;60(7):1884-94. doi: 10.1002/art.24632. Erratum in: Arthritis Rheum. 2009 Aug;60(8):2540. Lorthololary, O [corrected to Lortholary, O].

full_name: F. Tubach

given: F.

full_name: D. Salmon

given: D.

full_name: P. Ravaud

given: P.

family: Allanore

full_name: Y. Allanore

given: Y.

family: Goupille

full_name: P. Goupille

family: Bréban

full_name: M. Bréban

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

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

title: Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective french research axed on tolerance of biotherapies registry

location_facility: All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine


title: Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy

acronym: ALVEOLE

summary:
Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy).

The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases.

The goals of this French Phase II trial are:

to evaluate the tolerance of the alveoscopy
to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases

ReferenceCitation: Salaün M, Guisier F, Dominique S, Genevois A, Jounieaux V, Bergot E, Thill C, Piton N, Thiberville L. In vivo probe-based confocal laser endomicroscopy in chronic interstitial lung diseases: Specific descriptors and correlation with chest CT. Respirology. 2019 Aug;24(8):783-791. doi: 10.1111/resp.13507. Epub 2019 Feb 27.

name: Normandie UniversitéUNIROUEN Rouen France

name: Department of Pulmonology and CIC‐CRB 1404Rouen University Hospital Rouen France

family: Salaün

full_name: Mathieu Salaün

given: Mathieu

family: Guisier

full_name: Florian Guisier

given: Florian

family: Dominique

full_name: Stéphane Dominique

given: Stéphane

name: Department of RadiologyRouen University Hospital Rouen France

family: Genevois

full_name: Anne Genevois

given: Anne

name: Department of PulmonologyAmiens University Hospital Amiens France

family: Jounieaux

full_name: Vincent Jounieaux

given: Vincent

name: Department of PulmonologyCaen University Hospital Caen France

family: Bergot

full_name: Emmanuel Bergot

given: Emmanuel

name: Department of BiostatisticsRouen University Hospital Rouen France

family: Thill

full_name: Caroline Thill

given: Caroline

name: Department of Cytology and PathologyRouen University Hospital Rouen France

family: Piton

full_name: Nicolas Piton

given: Nicolas

family: Thiberville

full_name: Luc Thiberville

given: Luc

journal_name: Respirology

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: In vivo probe‐based confocal laser endomicroscopy in chronic interstitial lung diseases: Specific descriptors and correlation with chest CT

lead_sponsor: University Hospital, Rouen


title: Study of Diagnostic Biomarkers of Acute Acoustic Trauma

acronym: BIOTSA

summary:
Every year, more than two thousand acute acoustic trauma occur in France, equally between the military and the civilian environment.

Currently, acute acoustic trauma is a pathology with no specific validated treatment, and it is the cause of many handicapping situations. Improving the future of patients requires a better understanding of the neurophysiological mechanisms of noise-induced hearing impairment. They are multiple and pure tone audiometry, the only reference examination, does not allow to differentiate them. Moreover, in the aftermath of acute acoustic trauma, pure tone audiometry tends to improve spontaneously, but this recovery is misleading, as a number of studies in animals have shown that irreversible lesions remain.

The hypothesis of this study is that it is possible to identify new entities, specific to the type of cochlear lesions, in order to clarify the diagnosis of acute acoustic trauma. These entities will be identified by the evaluation of noise-induced hearing impairment via a combination of molecular (proteomic and genomic), physiological and behavioral data. These diagnostic details may then be used to improve prevention or therapy.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program

acronym: REMUSCLON

summary:
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.

Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.

Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.

Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion

acronym: DOMASNA

summary:
The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

acronym: ARABICA

summary: Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. The endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. The use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. In oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. In this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. No study has specifically looked at the use of devices of this type in the context of digestive cancer. The investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.


title: Awareness on Cancer in Persons With Intellectual Disabilities

acronym: ONCODEFI

summary:
Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject.

Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique


title: Constitutional Genetics to Predict Prognostic and Somatic Alterations in Follicular Lymphoma

acronym: CONPIL

summary:
Follicular lymphoma is the second most common adult B-cell lymphoma. The acquisition of the t(14;18) translocation is the genetic hallmark of Follicular lymphoma. However, 50% to 70% of healthy individuals harbor low levels of circulating t(14;18)-positive cells but will never develop Follicular lymphoma. It was observed that individuals who developed Follicular lymphoma showed a higher t(14;18) frequency than controls (Roulland et al., J Clin Oncol 2014). High t(14;18) frequency in blood from healthy individuals could be a predictive biomarker for Follicular lymphoma development. Genetic instability of those t(14;18)+ B-cells as well as failure of the micro-environment to control the proliferation of these cells are proposed mechanisms linking these lymphoma precursors to true lymphoma cells. The prognosis of Follicular lymphoma patients has been significantly improved mainly with the development of anti-CD20 monoclonal antibodies, with a current median overall survival over 15 years. However, this lymphoma remains an incurable disease. The most commonly used tool for prognostication of patients with Follicular lymphoma is the Follicular Lymphoma International Prognostic Index (FLIPI) based on conventional clinical and pathology parameters. Although it has clinical utility, the Follicular Lymphoma International Prognostic Index does not reflect the biologic heterogeneity of Follicular lymphoma. First-degree relatives of Follicular lymphoma had a fourfold increased risk of Follicular lymphoma suggesting a genetic etiology.

Using the Genome wide association studies (GWAS) approach on Follicular lymphoma cohorts of 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data. The investigators also plan to analyze the influence of single-nucleotide polymorphisms on circulating t(14;18) levels in 318 healthy individuals included in EPIC cohort that will develop Follicular lymphoma later on, and assess if these biomarkers are helpful to refine the identification of high-risk Follicular lymphoma individuals.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

intervention_type: Genetic


title: Immune Response and Risk of Serious Infection to SARS-Cov2

summary:
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.


title: Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia

acronym: QUALITY BIS

summary:
Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.

To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.

The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).

However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.


title: Diagnostic Exclusion Value of a Negative Single Distal and Proximal Lower Limb Veins Compression Ultrasonography in Pregnant and Post-partum Women With a Clinically Suspected Deep Vein Thrombosis

acronym: EDVIGE

summary: The objective of the EDVIGE study is to determine whether a negative single distal and proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein thrombosis in pregnant and post-partum women with clinical suspicion of DVT.

ReferenceCitation: Le Gal G, Prins AM, Righini M, Bohec C, Lacut K, Germain P, Vergos JC, Kaczmarek R, Guias B, Collet M, Bressollette L, Oger E, Mottier D. Diagnostic value of a negative single complete compression ultrasound of the lower limbs to exclude the diagnosis of deep venous thrombosis in pregnant or postpartum women: a retrospective hospital-based study. Thromb Res. 2006;118(6):691-7. Epub 2006 Jan 18.

ReferenceCitation: Righini M, Robert-Ebadi H, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rutschmann OT, Poletti PA, Le Gal G; CT-PE-Pregnancy Group. Diagnosis of Pulmonary Embolism During Pregnancy: A Multicenter Prospective Management Outcome Study. Ann Intern Med. 2018 Dec 4;169(11):766-773. doi: 10.7326/M18-1670. Epub 2018 Oct 23.

name: Geneva University Hospitals, Geneva, Switzerland (M.R., H.R., O.T.R., P.P.)

family: Righini

full_name: Marc Righini

given: Marc

family: Robert-Ebadi

full_name: Helia Robert-Ebadi

given: Helia

name: Centre Hospitalier de Toulon, Toulon, France (A.E.)

family: Elias

full_name: Antoine Elias

given: Antoine

name: Université Paris Descartes, Sorbonne Paris Cité, and Hôpital Européen Georges Pompidou, Paris, France (O.S.)

family: Sanchez

full_name: Olivier Sanchez

name: INSERM UMR S 1140, Paris, France, F-CRIN INNOVTE, Saint-Etienne, France, and Université de Brest, Brest, France (E.L.)

family: Le Moigne

full_name: Emmanuelle Le Moigne

given: Emmanuelle

name: Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France (J.S.)

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

name: Centre Hospitalier d'Argenteuil, Argenteuil, France (C.L.)

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

name: Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (J.C.)

family: Cornuz

full_name: Jacques Cornuz

given: Jacques

name: Bern University Hospital, University of Bern, Bern, Switzerland (D.A.)

family: Aujesky

full_name: Drahomir Aujesky

given: Drahomir

name: University Hospital of Angers, Angers, France (P.R.)

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: INSERM U1059, University of Lyon, and University Hospital, Saint-Etienne, France (C.C.)

family: Chauleur

full_name: Céline Chauleur

given: Céline

family: Rutschmann

full_name: Olivier T. Rutschmann

given: Olivier T.

family: Poletti

full_name: Pierre-Alexandre Poletti

given: Pierre-Alexandre

name: Université de Brest, Brest, France, and Ottawa Health Research Institute, Ottawa, Ontario, Canada (G.L.)

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

ReferenceCitation: Righini M, Jobic C, Boehlen F, Broussaud J, Becker F, Jaffrelot M, Blondon M, Guias B, Le Gal G; EDVIGE study group. Predicting deep venous thrombosis in pregnancy: external validation of the LEFT clinical prediction rule. Haematologica. 2013 Apr;98(4):545-8. doi: 10.3324/haematol.2012.072009. Epub 2012 Oct 12.

full_name: M. Righini

given: M.

family: Jobic

full_name: C. Jobic

given: C.

family: Boehlen

full_name: F. Boehlen

family: Broussaud

full_name: J. Broussaud

given: J.

family: Becker

full_name: F. Becker

family: Jaffrelot

full_name: M. Jaffrelot

family: Blondon

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Le Gal G, Kercret G, Ben Yahmed K, Bressollette L, Robert-Ebadi H, Riberdy L, Louis P, Delluc A, Labalette ML, Baba-Ahmed M, Bounameaux H, Mottier D, Righini M; EDVIGE Study Group. Diagnostic value of single complete compression ultrasonography in pregnant and postpartum women with suspected deep vein thrombosis: prospective study. BMJ. 2012 Apr 24;344:e2635. doi: 10.1136/bmj.e2635.

repository_institution: University of Geneva - Archive ouverte UNIGE

location_facility: Division of Angiology and Hemostasis, Geneva University Hospital


title: Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)

acronym: ROTHY

summary:
Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.

ReferenceCitation: Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.

lead_sponsor: Centre Leon Berard


title: Effect of Urine Alkalinazation on Urinary Inflammatory Markers Analyzed Using Mass Spectrometry in Patients With Cystinuria

summary:
It has recently been described the presence of a urinary inflammatory signature in patients with cystinuria, the most common cause of renal lithiasis of genetical origin. These data are very innovative in this pathology but deserve further studies to establish the specificity of this inflammatory signature in patients with cystinuria compared to other nephropathies and other renal lithiasis diseases. Moreover, the effect of the usual treatment of cystinuria (namely urine alkalanization) on urinary inflammatory biomarkers deserves to be tested.

The objectives of the present study are: i) To study the urinary inflammatory profile by mass spectrometry (a very efficient tool to detect and identify proteins) in patients with cystinuria and in patients with lithiasis of other origin and in patients with inflammatory renal disease ; ii) To study the potential effect of urine alkalinazation with potassium citrate (usual treatment according to European recommendations) on the inflammatory signature of patients with cystinuria. To this aim, urine of non treated cystinuric patients will be collected before treatement initiation and 3 months after the start of the alkalizing treatment.

ReferenceCitation: Bourderioux M, Nguyen-Khoa T, Chhuon C, Jeanson L, Tondelier D, Walczak M, Ollero M, Bekri S, Knebelmann B, Escudier E, Escudier B, Edelman A, Guerrera IC. A new workflow for proteomic analysis of urinary exosomes and assessment in cystinuria patients. J Proteome Res. 2015 Jan 2;14(1):567-77. doi: 10.1021/pr501003q. Epub 2014 Nov 12.

family: Bourderioux

full_name: Matthieu Bourderioux

given: Matthieu

family: Nguyen-Khoa

full_name: Thao Nguyen-Khoa

given: Thao

family: Chhuon

full_name: Cerina Chhuon

given: Cerina

name:
INSERM/UMR
S933, Université Pierre et Marie Curie, 75005 Paris, France

family: Jeanson

full_name: Ludovic Jeanson

given: Ludovic

family: Tondelier

full_name: Danielle Tondelier

given: Danielle

family: Walczak

full_name: Marta Walczak

given: Marta

name:
INSERM
U955, Université Paris−Est Créteil Val-de-Marne, 94010 Créteil, France

family: Ollero

full_name: Mario Ollero

given: Mario

name:
Department
of Biochemistry, CHU Charles Nicolle, 76000 Rouen, France

family: Bekri

full_name: Soumeya Bekri

given: Soumeya

family: Knebelmann

full_name: Bertrand Knebelmann

given: Bertrand

family: Escudier

full_name: Estelle Escudier

given: Estelle

name:
Department
of Medical Oncology, Institut Gustave Roussy, 94805 Villejuif, France

full_name: Bernard Escudier

given: Bernard

family: Edelman

full_name: Aleksander Edelman

given: Aleksander

family: Guerrera

full_name: Ida Chiara Guerrera

given: Ida Chiara

journal_name: Journal of Proteome Research

publisher: American Chemical Society (ACS)

publisher_dissemination: American Chemical Society

publisher_group: American Chemical Society

publisher_normalized: American Chemical Society

title: A New Workflow for Proteomic Analysis of Urinary Exosomes and Assessment in Cystinuria Patients

ReferenceCitation: Prot-Bertoye C, Lebbah S, Daudon M, Tostivint I, Bataille P, Bridoux F, Brignon P, Choquenet C, Cochat P, Combe C, Conort P, Decramer S, Doré B, Dussol B, Essig M, Gaunez N, Joly D, Le Toquin-Bernard S, Méjean A, Meria P, Morin D, N'Guyen HV, Noël C, Normand M, Pietak M, Ronco P, Saussine C, Tsimaratos M, Friedlander G, Traxer O, Knebelmann B, Courbebaisse M; French Cystinuria Group. CKD and Its Risk Factors among Patients with Cystinuria. Clin J Am Soc Nephrol. 2015 May 7;10(5):842-51. doi: 10.2215/CJN.06680714. Epub 2015 Feb 25.

family: Prot-Bertoye

full_name: Caroline Prot-Bertoye

given: Caroline

family: Lebbah

full_name: Saïd Lebbah

given: Saïd

family: Daudon

full_name: Michel Daudon

given: Michel

family: Tostivint

full_name: Isabelle Tostivint

given: Isabelle

family: Bataille

full_name: Pierre Bataille

given: Pierre

family: Bridoux

full_name: Franck Bridoux

given: Franck

family: Brignon

full_name: Pierre Brignon

family: Choquenet

full_name: Christian Choquenet

given: Christian

journal_name: Clinical Journal of the American Society of Nephrology


lead_sponsor: University Hospital, Clermont-Ferrand

acronym: MAX-AMOX

type: EudraCT Number

source: euctr

title: Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment : Intra- and Inter-individual Variability, Factors Associated With Overdose and Adverse Events

summary: Amoxicillin is the most prescribed antibiotic in France. High dose intravenous amoxicillin, (dosage greater than or equal to 150 mg / kg / day or 12 g per day for patients over 80 kg) is used in the treatment, in particular, of infectious streptococcal endocarditis. oral, streptococci gallolyticus and enterococci, infections of the central nervous system with sensitive germs including Streptococcus pneumoniae and Listeria monocytogenes, osteo articular infections. The dose-related adverse effects of this antibiotic are nephrological (crystalluria may lead to acute renal failure) and neurologic. Recently, the number of amoxicillin crystalluria reported to pharmacovigilance centers has increased, having led the National Agency of drug and health products safety (ANSM) to recommend the determination of the residual level of amoxicillin during the first week of treatment of these patients. Nevertheless, there is no precise therapeutic target in patients treated with high dose amoxicillin except in the context of critical care. The authors suggest the interest of a target between 4 and 10 times the minimum inhibitory concentration (MIC) based on in vitro efficacy studies, and retrospective observations of toxicity cases.


title: Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons

acronym: RUGBY-COM

summary: Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.

lead_sponsor: University Hospital, Bordeaux


title: The Patient Navigator to Reduce Social Inequalities. A French Interventional Trial in Public Health

acronym: PRADO

summary: Variations in participation to the colorectal cancer screening seems to reveal social and geographical inequalities. Our study will investigate whether patient navigation could increase the participation to the colorectal cancer screening and in the same time, reduce the social inequalities.

ReferenceCitation: Dejardin O, Berchi C, Mignon A, Pornet C, Guillaume E, Guittet L, Bouvier V, Sailly M, Salinas A, Christophe V, Launoy G. [Social inequalities in health from observational studies to intervention: can the patient navigator reduce social inequalities in cancer patients?]. Rev Epidemiol Sante Publique. 2011 Feb;59(1):45-51. doi: 10.1016/j.respe.2010.10.008. Epub 2011 Jan 21. Review. French.

ReferenceCitation: De Mil R, Guillaume E, Guittet L, Dejardin O, Bouvier V, Pornet C, Christophe V, Notari A, Delattre-Massy H, De Seze C, Peng J, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. Value Health. 2018 Jun;21(6):685-691. doi: 10.1016/j.jval.2017.09.020. Epub 2017 Nov 10.

family: De Mil

full_name: Rémy De Mil

given: Rémy

family: Guillaume

full_name: Elodie Guillaume

given: Elodie

family: Guittet

full_name: Lydia Guittet

given: Lydia

family: Dejardin

full_name: Olivier Dejardin

given: Olivier

family: Bouvier

full_name: Véronique Bouvier

given: Véronique

family: Pornet

full_name: Carole Pornet

given: Carole

family: Christophe

full_name: Véronique Christophe

family: Notari

full_name: Annick Notari

given: Annick

family: Delattre-Massy

full_name: Hélène Delattre-Massy

given: Hélène

family: De Seze

full_name: Chantal De Seze

given: Chantal

family: Peng

full_name: Jérôme Peng

given: Jérôme

family: Launoy

full_name: Guy Launoy

given: Guy

family: Berchi

full_name: Célia Berchi

given: Célia

journal_name: Value in Health

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Guillaume E, Dejardin O, Bouvier V, De Mil R, Berchi C, Pornet C, Christophe V, Notari A, Delattre Massy H, De Seze C, Peng J, Guittet L, Launoy G. Patient navigation to reduce social inequalities in colorectal cancer screening participation: A cluster randomized controlled trial. Prev Med. 2017 Oct;103:76-83. doi: 10.1016/j.ypmed.2017.08.012. Epub 2017 Aug 16.


title: Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study

acronym: PYELOBLSE

summary:
Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal treatment of E-ESBL is nearly impossible at this time.

Our aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.

ReferenceCitation: Cheng CH, Tsai MH, Huang YC, Su LH, Tsau YK, Lin CJ, Chiu CH, Lin TY. Antibiotic resistance patterns of community-acquired urinary tract infections in children with vesicoureteral reflux receiving prophylactic antibiotic therapy. Pediatrics. 2008 Dec;122(6):1212-7. doi: 10.1542/peds.2007-2926.

ReferenceCitation: Paterson DL, Ko WC, Von Gottberg A, Mohapatra S, Casellas JM, Goossens H, Mulazimoglu L, Trenholme G, Klugman KP, Bonomo RA, Rice LB, Wagener MM, McCormack JG, Yu VL. Antibiotic therapy for Klebsiella pneumoniae bacteremia: implications of production of extended-spectrum beta-lactamases. Clin Infect Dis. 2004 Jul 1;39(1):31-7. Epub 2004 Jun 8.

ReferenceCitation: Boyer-Mariotte S, Duboc P, Bonacorsi S, Lemeland JF, Bingen E, Pinquier D. CTX-M-15-producing Escherichia coli in fatal neonatal meningitis: failure of empirical chemotherapy. J Antimicrob Chemother. 2008 Dec;62(6):1472-4. doi: 10.1093/jac/dkn362. Epub 2008 Sep 4.

ReferenceCitation: Fournier S, Brun-Buisson C, Jarlier V. Twenty years of antimicrobial resistance control programme in a regional multi hospital institution, with focus on emerging bacteria (VRE and CPE). Antimicrob Resist Infect Control. 2012 Feb 13;1(1):9. doi: 10.1186/2047-2994-1-9.

ReferenceCitation: Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315.

family: Birgy

full_name: André Birgy

given: André

family: Cohen

full_name: Robert Cohen

given: Robert

family: Levy

full_name: Corinne Levy

given: Corinne

family: Bidet

full_name: Philippe Bidet

given: Philippe

family: Courroux

full_name: Céline Courroux

given: Céline

family: Benani

full_name: Mohamed Benani

given: Mohamed

family: Thollot

full_name: Franck Thollot

family: Bingen

full_name: Edouard Bingen

given: Edouard

currency_apc_doaj: GBP

journal_name: BMC Infectious Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher_dissemination: Springer

publisher_group: Springer

title: Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceaein french children

ReferenceCitation: Madec JY, Lazizzera C, Châtre P, Meunier D, Martin S, Lepage G, Ménard MF, Lebreton P, Rambaud T. Prevalence of fecal carriage of acquired expanded-spectrum cephalosporin resistance in Enterobacteriaceae strains from cattle in France. J Clin Microbiol. 2008 Apr;46(4):1566-7. doi: 10.1128/JCM.02299-07. Epub 2008 Feb 13.

ReferenceCitation: Andriatahina T, Randrianirina F, Hariniana ER, Talarmin A, Raobijaona H, Buisson Y, Richard V. High prevalence of fecal carriage of extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in a pediatric unit in Madagascar. BMC Infect Dis. 2010 Jul 12;10:204. doi: 10.1186/1471-2334-10-204.

lead_sponsor: Fouad Madhi

location_facility: Hôpital Intercommunal de Villeneuve Saint-Georges

location_facility: Centre Hospitalier Général de Longjumeau


title: A Phase I-II Study to Evaluate, in Patients Operated for a Hepatic Resection of Colorectal Liver Metastases, a High Intensity Focused Ultrasound (HIFU) Procedure: Feasibility, Safety and Accuracy.

acronym: HIFU

summary: The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases. This is a phase I/II study.

ReferenceCitation: Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9.

ReferenceCitation: Bismuth H, Adam R, Lévi F, Farabos C, Waechter F, Castaing D, Majno P, Engerran L. Resection of nonresectable liver metastases from colorectal cancer after neoadjuvant chemotherapy. Ann Surg. 1996 Oct;224(4):509-20; discussion 520-2.

ReferenceCitation: Mulier S, Ni Y, Jamart J, Ruers T, Marchal G, Michel L. Local recurrence after hepatic radiofrequency coagulation: multivariate meta-analysis and review of contributing factors. Ann Surg. 2005 Aug;242(2):158-71. Review.

ReferenceCitation: Rivoire M, De Cian F, Meeus P, Négrier S, Sebban H, Kaemmerlen P. Combination of neoadjuvant chemotherapy with cryotherapy and surgical resection for the treatment of unresectable liver metastases from colorectal carcinoma. Cancer. 2002 Dec 1;95(11):2283-92.

ReferenceCitation: Antoniou A, Lovegrove RE, Tilney HS, Heriot AG, John TG, Rees M, Tekkis PP, Welsh FK. Meta-analysis of clinical outcome after first and second liver resection for colorectal metastases. Surgery. 2007 Jan;141(1):9-18. Epub 2006 Nov 17.

ReferenceCitation: Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142. Review.

ReferenceCitation: Garcea G, Lloyd TD, Aylott C, Maddern G, Berry DP. The emergent role of focal liver ablation techniques in the treatment of primary and secondary liver tumours. Eur J Cancer. 2003 Oct;39(15):2150-64. Review.

ReferenceCitation: Seifert JK, Morris DL. Indicators of recurrence following cryotherapy for hepatic metastases from colorectal cancer. Br J Surg. 1999 Feb;86(2):234-40.

ReferenceCitation: Coleman DJ, Lizzi FL, Driller J, Rosado AL, Burgess SE, Torpey JH, Smith ME, Silverman RH, Yablonski ME, Chang S, et al. Therapeutic ultrasound in the treatment of glaucoma. II. Clinical applications. Ophthalmology. 1985 Mar;92(3):347-53.

ReferenceCitation: Valtot F, Kopel J, Petit E, Moulin F, Haut J. [Treatment of refractory glaucoma with high density focused ultrasonics]. J Fr Ophtalmol. 1995;18(1):3-12. Review. French.

ReferenceCitation: Chapelon JY, Margonari J, Vernier F, Gorry F, Ecochard R, Gelet A. In vivo effects of high-intensity ultrasound on prostatic adenocarcinoma Dunning R3327. Cancer Res. 1992 Nov 15;52(22):6353-7.

ReferenceCitation: Poissonnier L, Chapelon JY, Rouvière O, Curiel L, Bouvier R, Martin X, Dubernard JM, Gelet A. Control of prostate cancer by transrectal HIFU in 227 patients. Eur Urol. 2007 Feb;51(2):381-7. Epub 2006 May 2.

ReferenceCitation: Kinsey AM, Diederich CJ, Rieke V, Nau WH, Pauly KB, Bouley D, Sommer G. Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: in vivo evaluation under MR guidance. Med Phys. 2008 May;35(5):2081-93.

ReferenceCitation: Madersbacher S, Pedevilla M, Vingers L, Susani M, Marberger M. Effect of high-intensity focused ultrasound on human prostate cancer in vivo. Cancer Res. 1995 Aug 1;55(15):3346-51.

ReferenceCitation: Vallancien G, Harouni M, Guillonneau B, Veillon B, Bougaran J. Ablation of superficial bladder tumors with focused extracorporeal pyrotherapy. Urology. 1996 Feb;47(2):204-7.

ReferenceCitation: Wu F, Wang ZB, Cao YD, Zhu XQ, Zhu H, Chen WZ, Zou JZ. "Wide local ablation" of localized breast cancer using high intensity focused ultrasound. J Surg Oncol. 2007 Aug 1;96(2):130-6.

ReferenceCitation: Melodelima D, Prat F, Fritsch J, Theillere Y, Cathignol D. Treatment of esophageal tumors using high intensity intraluminal ultrasound: first clinical results. J Transl Med. 2008 Jun 5;6:28. doi: 10.1186/1479-5876-6-28.

ReferenceCitation: Wu F, Wang ZB, Chen WZ, Zhu H, Bai J, Zou JZ, Li KQ, Jin CB, Xie FL, Su HB. Extracorporeal high intensity focused ultrasound ablation in the treatment of patients with large hepatocellular carcinoma. Ann Surg Oncol. 2004 Dec;11(12):1061-9. Epub 2004 Nov 15.

ReferenceCitation: Vaezy S, Fujimoto VY, Walker C, Martin RW, Chi EY, Crum LA. Treatment of uterine fibroid tumors in a nude mouse model using high-intensity focused ultrasound. Am J Obstet Gynecol. 2000 Jul;183(1):6-11.

ReferenceCitation: Marquet F, Pernot M, Aubry JF, Montaldo G, Marsac L, Tanter M, Fink M. Non-invasive transcranial ultrasound therapy based on a 3D CT scan: protocol validation and in vitro results. Phys Med Biol. 2009 May 7;54(9):2597-613. doi: 10.1088/0031-9155/54/9/001. Epub 2009 Apr 8.

ReferenceCitation: Uchida T, Ohkusa H, Nagata Y, Hyodo T, Satoh T, Irie A. Treatment of localized prostate cancer using high-intensity focused ultrasound. BJU Int. 2006 Jan;97(1):56-61.

ReferenceCitation: Melodelima D, N'Djin WA, Parmentier H, Chesnais S, Rivoire M, Chapelon JY. Thermal ablation by high-intensity-focused ultrasound using a toroid transducer increases the coagulated volume. Results of animal experiments. Ultrasound Med Biol. 2009 Mar;35(3):425-35. doi: 10.1016/j.ultrasmedbio.2008.09.020. Epub 2008 Dec 10.

ReferenceCitation: Parmentier H, Melodelima D, N'Djin A, Chesnais S, Chapelon JY, Rivoire M. High-intensity focused ultrasound ablation for the treatment of colorectal liver metastases during an open procedure: study on the pig. Ann Surg. 2009 Jan;249(1):129-36. doi: 10.1097/SLA.0b013e31818c70b6. Erratum in: Ann Surg. 2009 Sep;250(3):506. Hubert, Parmentier [corrected to Parmentier, Hubert]; David, Melodelima, David [corrected to Melodelima, David]; Apoutou, N'Djin [corrected to N'Djin, Apoutou]; Sabrina, Chesnais [corrected to Chesnais, Sabrina]; Yves, Chapelon Jean [corrected to Chapelon,.

ReferenceCitation: N'Djin WA, Melodelima D, Parmentier H, Chesnais S, Rivoire M, Chapelon JY. Utility of a tumor-mimic model for the evaluation of the accuracy of HIFU treatments. results of in vitro experiments in the liver. Ultrasound Med Biol. 2008 Dec;34(12):1934-43. doi: 10.1016/j.ultrasmedbio.2008.04.012. Epub 2008 Jul 14.

ReferenceCitation: Lee YJ, Wesley RA. Statistical contributions to phase II trials in cancer: interpretation, analysis and design. Semin Oncol. 1981 Dec;8(4):403-16.

ReferenceCitation: A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66.

ReferenceCitation: Dupré A, Melodelima D, Pérol D, Chen Y, Vincenot J, Chapelon JY, Rivoire M. First clinical experience of intra-operative high intensity focused ultrasound in patients with colorectal liver metastases: a phase I-IIa study. PLoS One. 2015 Feb 26;10(2):e0118212. doi: 10.1371/journal.pone.0118212. eCollection 2015. Erratum in: PLoS One. 2015;10(3):e0123751.

family: Dupré

full_name: Aurélien Dupré

given: Aurélien

family: Melodelima

full_name: David Melodelima

given: David

family: Pérol

full_name: David Pérol

family: Chen

full_name: Yao Chen

given: Yao

family: Vincenot

full_name: Jérémy Vincenot

given: Jérémy

family: Chapelon

full_name: Jean-Yves Chapelon

given: Jean-Yves

family: Rivoire

full_name: Michel Rivoire

given: Michel

currency_apc_doaj: USD

journal_name: PLOS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: First Clinical Experience of Intra-Operative High Intensity Focused Ultrasound in Patients with Colorectal Liver Metastases: A Phase I-IIa Study

intervention_type: Procedure


title: Nuchal Translucency Study - PAPP-A

summary: The aim of the study is to evaluate the risk of Down syndrome during the first trimester of the pregnancy. The risk assessment is evaluated using early ultrasound and maternal biochemical markers.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Centre Mère et Enfant LE PARC, Service de Gynécologie Obstétrique

location_facility: Service de Gynécologie-Obstétrique, SIHCUS, CMCO

location_facility: Département de Gynécologie-Obstétrique, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: A Multicenter Phase II Pilot Open Label Study to Evaluate the Efficacy and Safety of BKM120 in the Treatment of Patients With Advanced or Metastatic Differentiated Thyroid Cancers

summary:
In France, 7-8 000 new thyroid cancer cases are diagnosed each year. Although a good overall prognosis, it is usually estimated that 10 to 20% will rescue and 5% will become metastatic.

The standard treatment of advanced metastatic or recurrent thyroid cancer is limited to radioiodine therapy. It is estimated that 30 to 50% of patients will become resistant to radio iodine. Treatments options are limited in these refractory thyroid patients and long term survival is estimated to less than 10%. Nowadays, no drug is approved in this indication.

The recent explosion in knowledge in tumour biology and the identification of potential biological targets in thyroid cancer led to several clinical trials with targeted therapies, mainly focused on TKI inhibitors targeting the MAPkinase pathway and/or VEGF. Preliminary results were encouraging in papillary thyroid tumors.

Follicular (FTC) and poorly differentiated thyroid (PDTC) cancers account for 10% of thyroid cancer but 20-25% of cancers diagnosed at an advanced stage and near 50% of metastatic refractory thyroid cancers. These cancers with an aggressive behavior represent a major cause of death from thyroid cancer. In these subtypes, targeted therapies gave disappointing results. This may be related to the mutational profile of these tumors which is different from that of papillary cancers. Aberrant activation of the phosphatidylinositol-3-kinase (PI3K)/AKT pathway is thought to play a fundamental role in thyroid tumorigenenesis of follicular and poorly differentiated thyroid cancers. Many genetic alterations have been, recently, identified in this pathway. PIK3CA mutations are found in 10-15% of FTC and can also occur in metastases derived from PDTC. Amplification/genomic copy gain of the PIK3CA has been identified in 24% of FTC and 42% of PDTC. Epigenetic inactivation of PTEN which negatively regulates PI3K has been shown in FTC. Moreover, RAS mutations observed in 20-40% of FTC and PDTC can activate the PI3K/AKT by interacting with the RAS-binding site of the P110 catalytic subunit of PI3K.

Due to the high frequency of activation of PI3K and downstream effectors in progressive, recurrent and poorly differentiated cancers, inhibition of the PI3K signaling pathway with BKM120, a potent pan class I PI3K inhibitor, represents a particularly relevant therapeutic target and should be properly evaluated in advanced follicular and poorly differentiated thyroid carcinomas

ReferenceCitation: Borson-Chazot F, Dantony E, Illouz F, Lopez J, Niccoli P, Wassermann J, Do Cao C, Leboulleux S, Klein M, Tabarin A, Eberle MC, Benisvy D, de la Fouchardière C, Bournaud C, Lasolle H, Delahaye A, Rabilloud M, Lapras V, Decaussin-Petrucci M, Schlumberger M. Effect of Buparlisib, a Pan-Class I PI3K Inhibitor, in Refractory Follicular and Poorly Differentiated Thyroid Cancer. Thyroid. 2018 Sep;28(9):1174-1179. doi: 10.1089/thy.2017.0663.

name: Fédération d'Endocrinologie, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France.

family: Borson-Chazot

full_name: Francoise Borson-Chazot

given: Francoise

name: Service de Biostatistique-Bioinformatique, Hospices Civils de Lyon, Université Lyon 1, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France.

family: Dantony

full_name: Emmanuelle Dantony

given: Emmanuelle

name: Service d'Endocrinologie, Centre de Référence de la Thyroïde et des Récepteurs Hormonaux, Centre Hospitalier Universitaire d'Angers, France.

family: Illouz

full_name: Frederic Illouz

given: Frederic

name: Service de Biochimie et Biologie moléculaire, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Université Lyon 1, France.

family: Lopez

full_name: Jonathan Lopez

given: Jonathan

name: Departement d'Oncologie Médicale, Institut Paoli Calmette, Marseille, France.

family: Niccoli

full_name: Patricia Niccoli

given: Patricia

name: Département d'oncologie Médicale, Hôpital Pitié Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Sorbonne, Paris, France.

family: Wassermann

full_name: Johanna Wassermann

given: Johanna

name: Service d'Endocrinologie, Centre Hospitalier Regional et Universitaire Lille, France.

family: Do Cao

full_name: Christine Do Cao

given: Christine

name: Service de Médecine Nucléaire et de Cancérologie Endocrinienne, Institut Gustave Roussy, Villejuif et Université Paris Saclay, France.

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

name: Service d'Endocrinologie, Centre Hospitalier Universitaire et Université de Nancy, France.

family: Klein

full_name: Marc Klein

given: Marc

name: Service d'Endocrinologie, Centre Hospitalier Universitaire et Université de Bordeaux, France.

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

name: Service de Médecine Nucléaire, Institut du Cancer de Montpellier, France.

family: Eberle

full_name: Marie-Claude Eberle

given: Marie-Claude

name: Service de Médecine Nucléaire, Centre Antoine Lacassagne, Nice, France.

family: Benisvy

full_name: Danielle Benisvy

given: Danielle

name: Département d'Oncologie Médicale, Centre Léon Bérard, Lyon, France.

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

name: Centre de Médecine Nucléaire, Groupement Hospitalier Est, Hospices Civils de Lyon, France.

family: Bournaud

full_name: Claire Bournaud

given: Claire

family: Lasolle

full_name: Helene Lasolle

given: Helene

family: Delahaye

full_name: Armelle Delahaye

given: Armelle

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

name: Service de Radiologie, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, France.

family: Lapras

full_name: Véronique Lapras

given: Véronique

name: Service d'Anatomie et Cytologie Pathologiques, Groupement Hospitalier Lyon Sud, Hospices Civils de Lyon, et Université Lyon 1, France.

family: Decaussin-Petrucci

full_name: Myriam Decaussin-Petrucci

given: Myriam

family: Schlumberger

full_name: Martin Schlumberger

given: Martin

journal_name: Thyroid

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc


title: Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study

acronym: DOVISCAN

summary: The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).

lead_sponsor: Central Hospital, Nancy, France


title: Comparison of Two Modes of Administration of the IADL Questionnaire

acronym: IADL

summary:
In France, about 1 million people 65 and older are diagnosed with dementia syndrome characterized by cognitive decline and impairment of functional capacity. The assessment of the level of functional autonomy is therefore an essential step in monitoring patients in Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients' ability to perform daily tasks.

In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during a face-to-face interview between their primary caregiver and a nurse, using the IADL questionnaire. This assessment should be renewed every year. The IADL questionnaire is part of the information that the memories consultations shall transmit to the Alzheimer's National Bank (BNA).

However, current practice has shown that the systematic collection is problematic in the organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in order to measure changes in the level of autonomy during the disease, and improve the completeness of this collection. A study is conducted with the main objective to measure the reliability of the assessment of IADL questionnaires conducted during a telephone interview with the caregiver of the patient, in comparison to the reference mode: the face-to-face interview with the caregiver.

Materials and methods The experimental design of the study will be a randomized crossover trial (crossover), including 394 patients divided into two branches. In the first part, the collection of the IADL questionnaire will be performed according to the reference method in the consultation (face-to-face interview with the nurse), the measurement will be repeated at 1 month intervals by phone. In the second part the sequence of execution modes will be reversed. The reliability of the measurement of the level of autonomy will be studied by comparing repeated measurements based on handover modes. The correspondence between the repeated measures will also be considered in terms of patient characteristics. The feasibility of administration of the questionnaire by phone mode will be evaluated.

Expected results The mode of administration by phone should allow to obtain a reliable measurement of the level of patient autonomy when the administration is carried out in a standardized way. The study should also identify patients and situations for which this method of administration by phone may be appropriate.

ReferenceCitation: Dauphinot V, Boublay N, Moutet C, Achi S, Bathsavanis A, Krolak-Salmon P. Comparison of Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews: a randomized, crossover study. Alzheimers Res Ther. 2020 Mar 13;12(1):24. doi: 10.1186/s13195-020-00590-w.

apc_source: openAPC

family: Dauphinot

full_name: Virginie Dauphinot

given: Virginie

family: Boublay

full_name: Nawèle Boublay

given: Nawèle

family: Moutet

full_name: Claire Moutet

family: Achi

full_name: Sarah Achi

given: Sarah

family: Bathsavanis

full_name: Anthony Bathsavanis

given: Anthony

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

journal_name: Alzheimer's Research & Therapy

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

location_facility: Hospices Civils de Lyon - Hôpital Charpennes - Memory Research Centre Lyon, Clinical Research Centre (CVF)


title: A Pilot Study to Evaluate the Clinical and Biological Tolerance of Sitagliptin With Pegylated Interferon alfa2a Plus Ribavirin Combination Therapy in Chronic Hepatitis C Patients

summary:
Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously resolve infection and 40-80% of chronically infected patients (numbers vary depending on viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent natural immunity and current therapeutic strategies, resulting in significant morbidity and mortality.

To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance. One molecule that has gained significant attention is CXCL10 (also known as interferon-gamma induced protein-10 or IP-10) as an important negative prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.

The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of specific inhibitors, the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Centre Hospitalier Intercommunal Créteil


title: Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy

acronym: FATSEIN

summary: The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.

ReferenceCitation: Rotonda C, Guillemin F, Bonnetain F, Conroy T. Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study. Contemp Clin Trials. 2011 Mar;32(2):244-9. doi: 10.1016/j.cct.2010.11.007. Epub 2010 Nov 13.

family: Rotonda

full_name: C. Rotonda

given: C.

family: Guillemin

full_name: F. Guillemin

given: F.

family: Bonnetain

full_name: F. Bonnetain

family: Conroy

full_name: T. Conroy

given: T.

journal_name: Contemporary Clinical Trials

title: Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: The FATSEIN study

location_facility:
Centre Alexis Vautrin
Centre Georges François Leclerc
Centre Paul Strauss