acronym: MegaMOST

lead_sponsor: Centre Leon Berard

summary:
This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment.

Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion.

In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers.

All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent.

Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor:

Evidence of clinical benefit as assessed by the investigators,
Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease,
No decline in ECOG Performance Status (PS) that can be attributed to disease progression.

location_facility:
Institut Bergonié
Centre Léon Bérard
Institut de Cancérologie de Strasbourg
Institut Claudius Regaud
Centre Antoine LACASSAGNE
Institut Gustave Roussy
Institut Paoli Calmettes
Institut Curie

title: MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.


type: Registry Identifier

title: Effect of a Tailored Program of Physical Activity and Nutritional Therapeutic Education on Clinical, Psychological and Sociological Factors in Breast Cancer Patients Undergoing Adjuvant Treatment : Multicenter Randomized Controlled Trial

summary: This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

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

location_facility:
Centre Léon Bérard
CH Ambroise Paré
ICM
Institut de Cancéologie de l'Ouest
CH Montélimar
Centre Oscar Lambret
Institut Sainte Catherine
Centre Eugène Marquis

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Drug

lead_sponsor: Zambon SpA

summary:
Primary Objective:

The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.

Secondary Objectives:

The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Centre Hospitalier Universitaire d'Angers

status: Terminated

title: A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation

primary_purpose: Treatment

type: EudraCT Number

source: euctr

location_country: Germany Spain France

ipd_sharing: No

status_simplified: Unknown


title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

acronym: BACHELOR

summary:
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included.

Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment.

No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion.

From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Eli Lilly and Company

location_facility:
CH Le Mans
CHU Montpellier
Chu Tours
CHU Nice
Ch Morlaix
CHU Brest
CHU Strasbourg
Chu Bordeaux

lead_sponsor_type: academique


title: Endoscopic Ultrasound Guided Choledocoduodenostomy With the Lumen Apposing Metal Stent [Axios® Stent]

summary: Endoscopic Ultrasound (EUS) guided biliary drainage is indicated in case of impossibility or failure of classic biliary drainage by endoscopic retrograde cholangio-pancreatography (ERCP). Recently the investigators reported a good efficiency of EUS guided choledocoduodenostomy using the HOT-AXIOS device (Electrocautery enhanced lumen apposing metal stent) in a retrospective multicentric study. Utilization of the recommended technique (direct punction with the HOT AXIOS using a pure cut current + using a 6 mm Stent) was the only predicting factor of clinical success. The investigators reevaluate this procedure one year after in the same centers.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: University Hospital, Limoges

location_facility:
Hospital Cournouaille
APHM Hospital La Timone
Hospital Private Jean MERMOZ
Hospital University
APHP Hospital Saint-Antoine
Hospital Jacques Lacarin
University Hospital


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years

status: Recruiting

title: A Reactogenicity, Safety and Immunogenicity Study of GSK's Paediatric Herpes Zoster Subunit Candidate Vaccine (PED-HZ/su) GSK143713A in Immunocompromised Paediatric Renal Transplant Recipients

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

study_completion_date_type: Anticipated

location_country:
Italy
United Kingdom
Spain
France

status_simplified: Ongoing


title: Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery

acronym: SURGICONNECT

summary:
Postoperative management in digestive surgery has been modernized thanks to improved rehabilitation measures. These measures include an earlier refeeding, mobilization, restriction of infusions (out of a total of 22) and showed their benefit in colorectal, gastric and bariatric surgery. It is thus possible to perform sleeve gastrectomy, bypass, restorations of digestive continuity and colectomies with early discharge or one day surgery.

The most serious complications (fistula, sepsis) occur in the first 10 days postoperatively with an average readmission rate of 10%. Their screening is based on clinical signs (tachycardia, pain) or biological (C-Reactive Protein (CRP) assay on Day 3 or Day 4). It is important to manage these complications early so that their morbidity is lower, resulting in shorter stays and less severity.

The monitoring and safety of patients discharged early are therefore essential and for the moment poorly codified, ranging from simple nursing to follow-up via a health provider. Recently, coordination structures including nurse platform and smartphone follow up app have emerged. Thanks to this system, the patient collects his own history and biological results which allows him to be monitored continuously, as in the hospital. In case of no filling or sign of complication, the nurse platform contacts the patient.

This connected follow-up would make it possible to reinforce the safety of the patient discharged early after a complex digestive procedure performed on an outpatient basis. Its benefit has been poorly evaluated but it is however more and more used by surgeons convinced of its interest especially as it goes in the direction of the development of the outpatient activity requested by the High Authority of Health with economic benefits interesting also the administration of the care structures.

The purpose of the investigator's study is to evaluate the impact of e-assessed follow-up during 10 days after surgery compared to a conventional follow-up. The hypothesis is that this connected follow-up would allow earlier detection of complications requiring rehospitalization (within 48 hours), resulting in faster and less severe treatment.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd

location_facility: Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon

location_facility: Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble

location_facility: Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon

location_facility: Service de Chirurgie Viscérale et Digestive, CH Emile Roux

location_facility: Service de Chirurgie Digestive et Oncologie Digestive, Hôpital Nord, CHU Saint-Etienne

location_facility: Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon

intervention_type: Device

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: SURGICONNECT

titre: Impact du suivi connecté sur le délai de prise en charge des complications post opératoires en chirurgie digestive

discipline_principale: prévention en santé

nom_porteur: PASQUER

prenom_porteur: Arnaud


title: A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation

acronym: SILK BM

summary:
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation.

Fifty patients will have to be enrolled in this phase II trial.

Total duration of treatment will be 12 months.

Patients will be followed for a maximum of 2 years following the date of inclusion.

status: Active, not recruiting

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de Bourgogne - Auxerre

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Centre Hospitalier Universitaire Lyon Sud

intervention_type: Combination Product


acronym: EPICURE

summary:
The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis are spontaneous, very variable, may occur as often as several times every day, and are recurrent in 90% of patients and associated with chronic and severe anemia in 2-10%. They also significantly reduce quality of life.

Blood transfusions are sometimes required in 10-30% of patients. Previous studies showed that antiangiogenic treatments such as anti-VEGF treatment (bevacizumab) administered intravenously was efficient on epistaxis and dramatically reduced nosebleeds.

Tyrosine kinase inhibitors are anti-angiogenic molecules which are available orally and could therefore overcome the difficulties encountered with bevacizumab. The investigator hypothesized that nintedanib, acting by indirect inhibition of the VEGF receptor should allow a reduction of epistaxis in HHT patient.

Nintedanib has been used in one HHT patient following the diagnosis of Insterstitial Pulmonary Fibrosis (published case report in 2017, Kovacs et al) with encouraging results.

The aim is to evaluate efficacy of nintedanib for the treatment of epistaxis in HHT patients

location_facility: Hôpital Femme-Mère-Enfant-Centre de Référence pour la maladie de Rendu-Osler

title: Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. A National, Randomized, Multicentre Phase II Study

appel_a_projets: PHRCN

acronyme: EPICURE

titre: Efficacité du nintedanid dans le traitement des épistaxis liés à la maladie de Rendu-Osler. Etude de phase II, randomisée contre placebo, Nationale, multicentrique.

discipline_principale: genetic

nom_porteur: DUPUIS-GIROD

prenom_porteur: Sophie


type: Other Identifier

title: End-ischemic Hypothermic Oxygenated Perfusion for Extended Criteria Donors in Liver Transplantation - A Multicenter, Randomized Controlled Trial

acronym: HOPExt

summary:
Given the scarce donor supply, an increasing number of so-called marginal or extended criteria donor (ECD) organs have been used for liver transplantation. These ECD liver grafts are, however, known to be associated with a higher rate of early allograft dysfunction (EAD) and primary non-function because of a greater vulnerability to ischemia-reperfusion injury. The end-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE) technique may improve outcomes of liver transplantation with ECD grafts by decreasing reperfusion injury.

The study aim is to assess the efficacy of HOPE used before transplantation of ECD liver grafts from brain-dead donors in reducing postoperative EAD within the first 7 postoperative days (POD) compared to simple cold static storage.

The study is comparative open-label, multicenter, national, prospective, randomized, in two parallel groups, using the gold standard procedure as control.

ReferenceType: background

ReferenceCitation: Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.

ReferenceCitation: Pareja E, Cortes M, Hervas D, Mir J, Valdivieso A, Castell JV, Lahoz A. A score model for the continuous grading of early allograft dysfunction severity. Liver Transpl. 2015 Jan;21(1):38-46. doi: 10.1002/lt.23990. Epub 2014 Nov 24.

ReferenceCitation: Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040. Erratum In: JAMA Surg. 2018 May 1;153(5):498.

location_facility: Hôpital Hautepierre - Department of HPB surgery and liver transplantation

location_facility: Department of HPB surgery and liver transplantation Claude Huriez University Hospital

location_facility: CHU Grenoble Alpes - Department of HPB surgery and liver transplantation

location_facility: Department of HPB surgery and liver transplantation Pontchaillou University Hospital

location_facility: Department of HPB surgery and liver transplantation Paul Brousse University Hospital

location_facility: Department of HPB surgery and liver transplantation Beaujon University Hospital

acronyme: HOPExt

titre: Perfusion Hypothermique Oxygénée en fin d'Ischémie (HOPE) des Greffons à Critères Elargis en Transplantation Hépatique  Essai randomisé multicentrique.

discipline_principale: visceral and digestive surgery

nom_porteur: LESURTEL

prenom_porteur: Mickaël


title: Pronostic Assessment of Mortality Among Locally Advanced or Metastatic Renal Cell Carcinoma Patients After First Line Treatment : Multicenter Prospective Cohort Study With Historic Medical Data

acronym: MERLIN

summary:
The hypothesis of this study are as follows:

Prognostic evaluation of patients based on an integrative model provides better assessment of overall survival, and thus improves setting of care goals.
In a routine care population, antitumour drugs may have a significant impact on overall survival through their targeted antitumor effect, but also through their toxicity profile and their impact on comorbidities.
The optimization of patient support (supportive care, drug tolerance monitoring) can have an impact on the prognosis.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Hôpital d'Instruction des Armées de Bégin


acronym: Pen ASAP

lead_sponsor: Mundipharma SAS

summary: A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma

sponsor_collaborators:
Mundipharma SAS
AXONAL
Exystat

location_facility:
GH Carnelle Porte de l'Oise
CHU Purpan
Hôpital Avicenne - APHP
CH René Dubos
CHRU Lille
Hôpital Edouard Herriot
Hospice civil de Lyon
CH Annecy Genevois

title: Multicentre, Randomised, Double-blind Study Assessing the Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Comparison to a Placebo Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma

collaborators: AXONAL Exystat


title: Effectiveness of the RemedRugby Program, a Program of Ecological Cognitive Remediation of Social Cognition Disorders in Schizophrenia

acronym: RemedRugby

summary:
REMEDRUGBY's objective is to strengthen the capacity of users to interact with others in an assertive way and to fight against stigma. It proposes to specifically target the processes of "social cognition".

"Social cognition" brings together the mental mechanisms that allow everyone to decipher the social situations, emotions and intentions of others and interact with others in the different contexts of everyday life.

People with a psychic handicap frequently have difficulties in this area, which has often important consequences for their social and professional integration.

The REMEDRUGBY program proposes to work specifically on these processes in the context of sport (+ role Play and blog) to strengthen the ability to interact with others and to deal with the stigma that can be encountered on a daily basis.

design_allocation: Non-Randomized

ReferenceCitation: Abu-Akel A. A neurobiological mapping of theory of mind. Brain Res Brain Res Rev. 2003 Sep;43(1):29-40. doi: 10.1016/s0165-0173(03)00190-5.

ReferenceCitation: Addington J, Addington D. Neurocognitive and social functioning in schizophrenia: a 2.5 year follow-up study. Schizophr Res. 2000 Jul 7;44(1):47-56. doi: 10.1016/s0920-9964(99)00160-7.

ReferenceCitation: Addington J, Saeedi H, Addington D. Influence of social perception and social knowledge on cognitive and social functioning in early psychosis. Br J Psychiatry. 2006 Oct;189:373-8. doi: 10.1192/bjp.bp.105.021022.

ReferenceCitation: Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.

ReferenceCitation: Baudouin JY, Martin F, Tiberghien G, Verlut I, Franck N. Selective attention to facial emotion and identity in schizophrenia. Neuropsychologia. 2002;40(5):503-11. doi: 10.1016/s0028-3932(01)00114-2.

ReferenceCitation: Baron-Cohen S, Leslie AM, Frith U. Does the autistic child have a "theory of mind"? Cognition. 1985 Oct;21(1):37-46. doi: 10.1016/0010-0277(85)90022-8. No abstract available.

ReferenceCitation: Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. doi: 10.1007/s11920-996-0035-x.

ReferenceCitation: Bentall RP, Corcoran R, Howard R, Blackwood N, Kinderman P. Persecutory delusions: a review and theoretical integration. Clin Psychol Rev. 2001 Nov;21(8):1143-92. doi: 10.1016/s0272-7358(01)00106-4.

ReferenceCitation: Bengtsson-Tops A. Mastery in patients with schizophrenia living in the community: relationship to sociodemographic and clinical characteristics, needs for care and support, and social network. J Psychiatr Ment Health Nurs. 2004 Jun;11(3):298-304. doi: 10.1111/j.1365-2850.2003.00718.x.

ReferenceCitation: Bertrand MC, Sutton H, Achim AM, Malla AK, Lepage M. Social cognitive impairments in first episode psychosis. Schizophr Res. 2007 Sep;95(1-3):124-33. doi: 10.1016/j.schres.2007.05.033. Epub 2007 Jul 16.

ReferenceCitation: Blair RJ. Responding to the emotions of others: dissociating forms of empathy through the study of typical and psychiatric populations. Conscious Cogn. 2005 Dec;14(4):698-718. doi: 10.1016/j.concog.2005.06.004. Epub 2005 Sep 12.

ReferenceCitation: Blanchard JJ, Mueser KT, Bellack AS. Anhedonia, positive and negative affect, and social functioning in schizophrenia. Schizophr Bull. 1998;24(3):413-24. doi: 10.1093/oxfordjournals.schbul.a033336.

ReferenceCitation: Bora E, Yucel M, Pantelis C. Theory of mind impairment in schizophrenia: meta-analysis. Schizophr Res. 2009 Apr;109(1-3):1-9. doi: 10.1016/j.schres.2008.12.020. Epub 2009 Feb 4.

ReferenceCitation: Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.

ReferenceCitation: Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.

ReferenceCitation: Brune M. "Theory of mind" in schizophrenia: a review of the literature. Schizophr Bull. 2005 Jan;31(1):21-42. doi: 10.1093/schbul/sbi002. Epub 2005 Feb 16.

ReferenceCitation: Chang WC, Hui CL, Tang JY, Wong GH, Lam MM, Chan SK, Chen EY. Persistent negative symptoms in first-episode schizophrenia: a prospective three-year follow-up study. Schizophr Res. 2011 Dec;133(1-3):22-8. doi: 10.1016/j.schres.2011.09.006. Epub 2011 Oct 2.

ReferenceCitation: Choi J, Fiszdon JM, Medalia A. Expectancy-value theory in persistence of learning effects in schizophrenia: role of task value and perceived competency. Schizophr Bull. 2010 Sep;36(5):957-65. doi: 10.1093/schbul/sbq078. Epub 2010 Jul 15.

ReferenceCitation: Combs DR, Adams SD, Penn DL, Roberts D, Tiegreen J, Stem P. Social Cognition and Interaction Training (SCIT) for inpatients with schizophrenia spectrum disorders: preliminary findings. Schizophr Res. 2007 Mar;91(1-3):112-6. doi: 10.1016/j.schres.2006.12.010. Epub 2007 Feb 12.

ReferenceCitation: Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.

ReferenceCitation: Corcoran R, Rowse G, Moore R, Blackwood N, Kinderman P, Howard R, Cummins S, Bentall RP. A transdiagnostic investigation of 'theory of mind' and 'jumping to conclusions' in patients with persecutory delusions. Psychol Med. 2008 Nov;38(11):1577-83. doi: 10.1017/S0033291707002152. Epub 2007 Nov 16.

ReferenceCitation: Couture SM, Penn DL, Roberts DL. The functional significance of social cognition in schizophrenia: a review. Schizophr Bull. 2006 Oct;32 Suppl 1(Suppl 1):S44-63. doi: 10.1093/schbul/sbl029. Epub 2006 Aug 17.

ReferenceCitation: Couture SM, Granholm EL, Fish SC. A path model investigation of neurocognition, theory of mind, social competence, negative symptoms and real-world functioning in schizophrenia. Schizophr Res. 2011 Feb;125(2-3):152-60. doi: 10.1016/j.schres.2010.09.020. Epub 2010 Oct 20.

ReferenceCitation: Darba J, Minoves A, Rojo E, Jimenez F, Rejas J. Efficacy of second-generation-antipsychotics in the treatment of negative symptoms of schizophrenia: a meta-analysis of randomized clinical trials. Rev Psiquiatr Salud Ment. 2011 Jul;4(3):126-43. doi: 10.1016/j.rpsm.2011.02.005. Epub 2011 Jun 14. English, Spanish.

ReferenceCitation: de Haan L, Linszen DH, Lenior ME, de Win ED, Gorsira R. Duration of untreated psychosis and outcome of schizophrenia: delay in intensive psychosocial treatment versus delay in treatment with antipsychotic medication. Schizophr Bull. 2003;29(2):341-8. doi: 10.1093/oxfordjournals.schbul.a007009.

ReferenceCitation: Demily C, Franck N. Cognitive remediation: a promising tool for the treatment of schizophrenia. Expert Rev Neurother. 2008 Jul;8(7):1029-36. doi: 10.1586/14737175.8.7.1029.

ReferenceCitation: Deutsch F, Madle RA. Empathy: historic and current conceptualizations, measurement, and a cognitive theoretical perspective. Hum Dev. 1975;18(4):267-87. doi: 10.1159/000271488. No abstract available.

ReferenceCitation: Dziobek I, Rogers K, Fleck S, Bahnemann M, Heekeren HR, Wolf OT, Convit A. Dissociation of cognitive and emotional empathy in adults with Asperger syndrome using the Multifaceted Empathy Test (MET). J Autism Dev Disord. 2008 Mar;38(3):464-73. doi: 10.1007/s10803-007-0486-x. Epub 2007 Nov 8.

ReferenceCitation: Edwards J, Jackson HJ, Pattison PE. Emotion recognition via facial expression and affective prosody in schizophrenia: a methodological review. Clin Psychol Rev. 2002 Jul;22(6):789-832. doi: 10.1016/s0272-7358(02)00130-7. Erratum In: Clin Psychol Rev. 2002 Nov;22(8):1267-85.

ReferenceCitation: Fett AK, Viechtbauer W, Dominguez MD, Penn DL, van Os J, Krabbendam L. The relationship between neurocognition and social cognition with functional outcomes in schizophrenia: a meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):573-88. doi: 10.1016/j.neubiorev.2010.07.001. Epub 2010 Jul 8.

ReferenceCitation: Jolley S, Garety P, Bebbington P, Dunn G, Freeman D, Kuipers E, Fowler D, Hemsley D. Attributional style in psychosis--the role of affect and belief type. Behav Res Ther. 2006 Nov;44(11):1597-607. doi: 10.1016/j.brat.2005.12.002. Epub 2006 Jan 24.

ReferenceCitation: Frith CD. Schizophrenia and theory of mind. Psychol Med. 2004 Apr;34(3):385-9. doi: 10.1017/s0033291703001326. No abstract available.

ReferenceCitation: Galderisi S, Bucci P, Mucci A, Kirkpatrick B, Pini S, Rossi A, Vita A, Maj M. Categorical and dimensional approaches to negative symptoms of schizophrenia: focus on long-term stability and functional outcome. Schizophr Res. 2013 Jun;147(1):157-162. doi: 10.1016/j.schres.2013.03.020. Epub 2013 Apr 19.

ReferenceCitation: Galderisi S, Mucci A, Bitter I, Libiger J, Bucci P, Fleischhacker WW, Kahn RS; Eufest Study Group. Persistent negative symptoms in first episode patients with schizophrenia: results from the European First Episode Schizophrenia Trial. Eur Neuropsychopharmacol. 2013 Mar;23(3):196-204. doi: 10.1016/j.euroneuro.2012.04.019. Epub 2012 May 28.

ReferenceCitation: Green MF, Olivier B, Crawley JN, Penn DL, Silverstein S. Social cognition in schizophrenia: recommendations from the measurement and treatment research to improve cognition in schizophrenia new approaches conference. Schizophr Bull. 2005 Oct;31(4):882-7. doi: 10.1093/schbul/sbi049. Epub 2005 Aug 31.

ReferenceCitation: Green MF, Penn DL, Bentall R, Carpenter WT, Gaebel W, Gur RC, Kring AM, Park S, Silverstein SM, Heinssen R. Social cognition in schizophrenia: an NIMH workshop on definitions, assessment, and research opportunities. Schizophr Bull. 2008 Nov;34(6):1211-20. doi: 10.1093/schbul/sbm145. Epub 2008 Jan 8.

ReferenceCitation: Green MF, Leitman DI. Social cognition in schizophrenia. Schizophr Bull. 2008 Jul;34(4):670-2. doi: 10.1093/schbul/sbn045. Epub 2008 May 20.

ReferenceCitation: Hardy-Bayle MC, Sarfati Y, Passerieux C. The cognitive basis of disorganization symptomatology in schizophrenia and its clinical correlates: toward a pathogenetic approach to disorganization. Schizophr Bull. 2003;29(3):459-71. doi: 10.1093/oxfordjournals.schbul.a007019.

ReferenceCitation: Kalpakci A, Vanwoerden S, Elhai JD, Sharp C. The Independent Contributions of Emotion Dysregulation and Hypermentalization to the "Double Dissociation" of Affective and Cognitive Empathy in Female Adolescent Inpatients With BPD. J Pers Disord. 2016 Apr;30(2):242-60. doi: 10.1521/pedi_2015_29_192. Epub 2015 Apr 23.

ReferenceCitation: Harrington L, Siegert RJ, McClure J. Theory of mind in schizophrenia: a critical review. Cogn Neuropsychiatry. 2005 Aug;10(4):249-86. doi: 10.1080/13546800444000056.

ReferenceCitation: Harvey PD, Koren D, Reichenberg A, Bowie CR. Negative symptoms and cognitive deficits: what is the nature of their relationship? Schizophr Bull. 2006 Apr;32(2):250-8. doi: 10.1093/schbul/sbj011. Epub 2005 Oct 12.

ReferenceCitation: Hoekert M, Kahn RS, Pijnenborg M, Aleman A. Impaired recognition and expression of emotional prosody in schizophrenia: review and meta-analysis. Schizophr Res. 2007 Nov;96(1-3):135-45. doi: 10.1016/j.schres.2007.07.023. Epub 2007 Sep 4.

ReferenceCitation: Kee KS, Green MF, Mintz J, Brekke JS. Is emotion processing a predictor of functional outcome in schizophrenia? Schizophr Bull. 2003;29(3):487-97. doi: 10.1093/oxfordjournals.schbul.a007021.

ReferenceCitation: Kohler CG, Bilker W, Hagendoorn M, Gur RE, Gur RC. Emotion recognition deficit in schizophrenia: association with symptomatology and cognition. Biol Psychiatry. 2000 Jul 15;48(2):127-36. doi: 10.1016/s0006-3223(00)00847-7.

ReferenceCitation: Jones AP, Happe FG, Gilbert F, Burnett S, Viding E. Feeling, caring, knowing: different types of empathy deficit in boys with psychopathic tendencies and autism spectrum disorder. J Child Psychol Psychiatry. 2010 Nov;51(11):1188-97. doi: 10.1111/j.1469-7610.2010.02280.x.

ReferenceCitation: Lahera G, Benito A, Montes JM, Fernandez-Liria A, Olbert CM, Penn DL. Social cognition and interaction training (SCIT) for outpatients with bipolar disorder. J Affect Disord. 2013 Mar 20;146(1):132-6. doi: 10.1016/j.jad.2012.06.032. Epub 2012 Jul 25.

ReferenceCitation: Lawrence EJ, Shaw P, Baker D, Patel M, Sierra-Siegert M, Medford N, David AS. Empathy and enduring depersonalization: the role of self-related processes. Soc Neurosci. 2007;2(3-4):292-306. doi: 10.1080/17470910701391794.

ReferenceCitation: Lin CH, Huang CL, Chang YC, Chen PW, Lin CY, Tsai GE, Lane HY. Clinical symptoms, mainly negative symptoms, mediate the influence of neurocognition and social cognition on functional outcome of schizophrenia. Schizophr Res. 2013 May;146(1-3):231-7. doi: 10.1016/j.schres.2013.02.009. Epub 2013 Mar 9.

ReferenceCitation: Livingston JD, Boyd JE. Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis. Soc Sci Med. 2010 Dec;71(12):2150-61. doi: 10.1016/j.socscimed.2010.09.030. Epub 2010 Oct 12.

ReferenceCitation: Lysaker PH, Beattie NL, Strasburger AM, Davis LW. Reported history of child sexual abuse in schizophrenia: associations with heightened symptom levels and poorer participation over four months in vocational rehabilitation. J Nerv Ment Dis. 2005 Dec;193(12):790-5. doi: 10.1097/01.nmd.0000188970.11916.76.

ReferenceCitation: MacLeod J, Nelson G. Programs for the promotion of family wellness and the prevention of child maltreatment: a meta-analytic review. Child Abuse Negl. 2000 Sep;24(9):1127-49. doi: 10.1016/s0145-2134(00)00178-2.

ReferenceCitation: Medalia A, Choi J. Cognitive remediation in schizophrenia. Neuropsychol Rev. 2009 Sep;19(3):353-64. doi: 10.1007/s11065-009-9097-y. Epub 2009 May 15.

ReferenceCitation: Medalia A, Saperstein A. The role of motivation for treatment success. Schizophr Bull. 2011 Sep;37 Suppl 2(Suppl 2):S122-8. doi: 10.1093/schbul/sbr063.

ReferenceCitation: Medalia A, Richardson R. What predicts a good response to cognitive remediation interventions? Schizophr Bull. 2005 Oct;31(4):942-53. doi: 10.1093/schbul/sbi045. Epub 2005 Aug 24.

ReferenceCitation: McGuire PK, Shah GM, Murray RM. Increased blood flow in Broca's area during auditory hallucinations in schizophrenia. Lancet. 1993 Sep 18;342(8873):703-6. doi: 10.1016/0140-6736(93)91707-s.

ReferenceCitation: McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.

ReferenceCitation: Montag C, Dziobek I, Richter IS, Neuhaus K, Lehmann A, Sylla R, Heekeren HR, Heinz A, Gallinat J. Different aspects of theory of mind in paranoid schizophrenia: evidence from a video-based assessment. Psychiatry Res. 2011 Apr 30;186(2-3):203-9. doi: 10.1016/j.psychres.2010.09.006. Epub 2010 Oct 14.

ReferenceCitation: Nakagami E, Hoe M, Brekke JS. The prospective relationships among intrinsic motivation, neurocognition, and psychosocial functioning in schizophrenia. Schizophr Bull. 2010 Sep;36(5):935-48. doi: 10.1093/schbul/sbq043. Epub 2010 May 12.

ReferenceCitation: Nasrallah H, Morosini P, Gagnon DD. Reliability, validity and ability to detect change of the Personal and Social Performance scale in patients with stable schizophrenia. Psychiatry Res. 2008 Nov 30;161(2):213-24. doi: 10.1016/j.psychres.2007.11.012. Epub 2008 Oct 11.

ReferenceCitation: Penn DL, Spaulding W, Reed D, Sullivan M. The relationship of social cognition to ward behavior in chronic schizophrenia. Schizophr Res. 1996 Jul 5;20(3):327-35. doi: 10.1016/0920-9964(96)00010-2.

ReferenceCitation: Penn DL, Corrigan PW, Bentall RP, Racenstein JM, Newman L. Social cognition in schizophrenia. Psychol Bull. 1997 Jan;121(1):114-32. doi: 10.1037/0033-2909.121.1.114.

ReferenceCitation: Penn D, Roberts DL, Munt ED, Silverstein E, Jones N, Sheitman B. A pilot study of social cognition and interaction training (SCIT) for schizophrenia. Schizophr Res. 2005 Dec 15;80(2-3):357-9. doi: 10.1016/j.schres.2005.07.011. Epub 2005 Aug 31. No abstract available.

ReferenceCitation: Penn DL, Sanna LJ, Roberts DL. Social cognition in schizophrenia: an overview. Schizophr Bull. 2008 May;34(3):408-11. doi: 10.1093/schbul/sbn014. Epub 2008 Mar 28.

lead_sponsor: Hospital Center Alpes-Isère

collaborators: Centre Hospitalier Spécialisé de la Savoie (Chambéry)

collaborators: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Centre Hospitalier Sainte Marie de Clermont Ferrand

sponsor_collaborators: Centre Hospitalier Spécialisé de la Savoie (Chambéry)

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

sponsor_collaborators: Centre Hospitalier Sainte Marie de Clermont Ferrand

location_facility:
Ch Annecy-Genevois
Ch Le Vinatier
HCAlpesIsere
Chu Saint-Etienne
CHU de CLERMONT-FERRAND
Chs Le Valmont
Ch Sainte-Marie
Chs de La Savoie


title: Study on the Occurrence of Head and Neck Cancers During Pregnancy

acronym: REFCORbirth

summary: Head and neck cancers that occurred during pregnancy

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
French scientific group REFCOR

location_facility:
Chu Poitiers
Chu Toulouse
Chu Bordeaux
Institut Gustave Roussy IGR
Chu Besancon
Ap-Hp Tenon
Centre François Baclesse
Chu Grenoble Alpes


title: PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)

acronym: PILBOUTOX

summary: Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Labadie M, Vaucel JA, Courtois A, Nisse P, Legeay M, Medernach C, Patat AM, Von Fabeck K, Gallart JC; French PCC Research Group; Tournoud C, Puskarczyk E. Button Battery Ingestion in Children (PilBouTox(R)): A Prospective Study Describing the Clinical Course and Identifying Factors Related to Esophageal Impaction or Severe Cases. Dysphagia. 2023 Feb;38(1):446-456. doi: 10.1007/s00455-022-10485-7. Epub 2022 Jul 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Bordeaux


title: DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression

acronym: DEPREDICT

summary:
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.

There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility: CHU de Tours, Clinique Psychiatrique Universitaire

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: DEPREDICT

titre: Détermination du profil clinique et neurobiologique prédictif de l'évolution péjorative de la dépression

discipline_principale: autre

nom_porteur: BATAIL

prenom_porteur: Jean-Marie


title: Optimization of Correcting Molecules of Nonsense Mutations in Epithelial Cells of the Upper Airways of Patients With Cystic Fibrosis With Nonsense Mutations in the CFTR Gene

summary:
The presence of a nonsense mutation leads to the rapid degradation of the carrier mRNA mutation by a mechanism called NMD (nonsense-mediated mRNA decay) [6, 13]. There are currently 3 main strategies at least for correcting nonsense mutations: exon skipping, inhibition of NMD and nonsense mutation readthrough.

In the laboratory, we developed a strategy for correcting nonsense mutations combining inhibition of NMD and activation of translecture. For this purpose, we have constructed screening systems to identify NMD-inhibiting and/or readthrough enhancers. The molecules thus identified are then tested on cell lines and in murine models carrying a nonsense mutation.

One of our goals is to select a set of molecules that can correct effectively nonsense mutations. For this we have to test these molecules on a great diversity of nonsense mutations.

This work will:

determine if we can correct all the nonsense mutations tested with at least one of our molecules
determine what is common within a group of mutations corrected by a given molecule
be able to assign the parameters that make one mutation is corrected by one molecule and not or little by another.

This study will therefore improve our theoretical knowledge on the recognition of premature stop codons but also to propose therapeutic approaches for the correction of nonsense mutations of the CFTR gene in cystic fibrosis in a targeted way for a patient.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Vaincre la Mucoviscidose

location_facility: Hu Paris Centre Site Cochin Aphp - Paris 14


title: Medico Economic Study, Randomized, Comparing Intraoperative Radiotherapy With Intrabeam® on Surgical Resection Bed Versus Conventional Surgery + EBRT in Postmenopausal Patients Operated by Conservative Surgery for Low Risk Breast Cancer

acronym: RIOP-SEIN

summary:
Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy.

This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with :

25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general);
16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence.

In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae.

Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation.

Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence.

The main advantages of IBRTare :

Improvement of the quality of life due to a single session of radiotherapy associated with surgical ;
Increased precision to deliver the necessary dose in tumour tissue;
Preservation of surrounding healthy tissue ;
Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions.

RIOP SEIN is a project supported by Institut National du Cancer (INCa)

, which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: INSTITUT REGIONAL DU CANCER MONTPELLIER - Val D'Aurelle

intervention_type: Radiation


title: Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

acronym: DFG

summary: This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.

ReferenceType: result

ReferenceCitation: Adler DG, Baron TH, Davila RE, Egan J, Hirota WK, Leighton JA, Qureshi W, Rajan E, Zuckerman MJ, Fanelli R, Wheeler-Harbaugh J, Faigel DO; Standards of Practice Committee of American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of ERCP in diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2005 Jul;62(1):1-8. doi: 10.1016/j.gie.2005.04.015. No abstract available.

ReferenceCitation: Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc. 2005 Jan;61(1):112-25. doi: 10.1016/s0016-5107(04)02463-0. No abstract available.

ReferenceCitation: Hisa T, Matsumoto R, Takamatsu M, Furutake M. Impact of changing our cannulation method on the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis after pancreatic guidewire placement. World J Gastroenterol. 2011 Dec 28;17(48):5289-94. doi: 10.3748/wjg.v17.i48.5289.

ReferenceCitation: Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.

ReferenceCitation: Artifon EL, Sakai P, Cunha JE, Halwan B, Ishioka S, Kumar A. Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation. Am J Gastroenterol. 2007 Oct;102(10):2147-53. doi: 10.1111/j.1572-0241.2007.01378.x. Epub 2007 Jun 20.

ReferenceCitation: Cennamo V, Fuccio L, Repici A, Fabbri C, Grilli D, Conio M, D'Imperio N, Bazzoli F. Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):473-9. doi: 10.1016/j.gie.2008.09.037.

ReferenceCitation: Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can early precut implementation reduce endoscopic retrograde cholangiopancreatography-related complication risk? Meta-analysis of randomized controlled trials. Endoscopy. 2010 May;42(5):381-8. doi: 10.1055/s-0029-1243992. Epub 2010 Mar 19.

ReferenceCitation: Parlak E, Cicek B, Disibeyaz S, Kuran S, Sahin B. Early decision for precut sphincterotomy: is it a risky preference? Dig Dis Sci. 2007 Mar;52(3):845-51. doi: 10.1007/s10620-006-9546-x.

ReferenceCitation: Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. doi: 10.1016/s0016-5107(96)70038-x. No abstract available.

ReferenceCitation: Gotoh Y, Tamada K, Tomiyama T, Wada S, Ohashi A, Satoh Y, Higashizawa T, Miyata T, Ido K, Sugano K. A new method for deep cannulation of the bile duct by straightening the pancreatic duct. Gastrointest Endosc. 2001 Jun;53(7):820-2. doi: 10.1067/mge.2001.113387. No abstract available.

ReferenceCitation: Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652-6. doi: 10.1067/mge.2002.129086.

ReferenceCitation: Caletti GC, Vandelli A, Bolondi L, Fontana G, Labo G. Endoscopic retrograde cholangiography (ERC) through artificial endoscopic choledocho-duodenal fistula. Endoscopy. 1978 Aug;10(3):203-6. doi: 10.1055/s-0028-1098295.

ReferenceCitation: Siegel JH. Precut papillotomy: a method to improve success of ERCP and papillotomy. Endoscopy. 1980 May;12(3):130-3. doi: 10.1055/s-2007-1021728.

ReferenceCitation: Osnes M, Kahrs T. Endoscopic choledochoduodenostomy for choledocholithiasis through choledochoduodenal fistula. Endoscopy. 1977 Aug;9(3):162-5. doi: 10.1055/s-0028-1098510.

ReferenceCitation: Dumonceau JM, Deviere J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy. 1998 Sep;30(7):S80. doi: 10.1055/s-2007-1001379. No abstract available.

ReferenceCitation: Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Ponauthai Y, Kullavanijaya P. Success rate and cannulation time between precut sphincterotomy and double-guidewire technique in truly difficult biliary cannulation. J Gastroenterol Hepatol. 2012 Feb;27(2):356-61. doi: 10.1111/j.1440-1746.2011.06927.x.

ReferenceCitation: Cote GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial. Dig Dis Sci. 2012 Dec;57(12):3271-8. doi: 10.1007/s10620-012-2269-2. Epub 2012 Jun 26.

ReferenceCitation: Herreros de Tejada A, Calleja JL, Diaz G, Pertejo V, Espinel J, Cacho G, Jimenez J, Millan I, Garcia F, Abreu L; UDOGUIA-04 Group. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc. 2009 Oct;70(4):700-9. doi: 10.1016/j.gie.2009.03.031. Epub 2009 Jun 27.

ReferenceCitation: Yoo YW, Cha SW, Lee WC, Kim SH, Kim A, Cho YD. Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation. World J Gastroenterol. 2013 Jan 7;19(1):108-14. doi: 10.3748/wjg.v19.i1.108.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Baishideng Publishing Group Inc.

ReferenceCitation: Xinopoulos D, Bassioukas SP, Kypreos D, Korkolis D, Scorilas A, Mavridis K, Dimitroulopoulos D, Paraskevas E. Pancreatic duct guidewire placement for biliary cannulation in a single-session therapeutic ERCP. World J Gastroenterol. 2011 Apr 21;17(15):1989-95. doi: 10.3748/wjg.v17.i15.1989.

ReferenceCitation: Lee TH, Hwang SO, Choi HJ, Jung Y, Cha SW, Chung IK, Moon JH, Cho YD, Park SH, Kim SJ. Sequential algorithm analysis to facilitate selective biliary access for difficult biliary cannulation in ERCP: a prospective clinical study. BMC Gastroenterol. 2014 Feb 17;14:30. doi: 10.1186/1471-230X-14-30.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: Springer

ReferenceCitation: Goff JS. Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy. Gastrointest Endosc. 1999 Nov;50(5):642-5. doi: 10.1016/s0016-5107(99)80012-1.

ReferenceCitation: Tang SJ, Haber GB, Kortan P, Zanati S, Cirocco M, Ennis M, Elfant A, Scheider D, Ter H, Dorais J. Precut papillotomy versus persistence in difficult biliary cannulation: a prospective randomized trial. Endoscopy. 2005 Jan;37(1):58-65. doi: 10.1055/s-2004-826077.

ReferenceCitation: Laquiere A, Privat J, Jacques J, Legros R, Urena-Campos R, Belkhodja H, Subtil C, Kanafi L, Lecomte L, Boustiere C, Katsogiannou M, Karsenti D. Early double-guidewire versus repeated single-guidewire technique to facilitate selective bile duct cannulation: a randomized controlled trial. Endoscopy. 2022 Feb;54(2):120-127. doi: 10.1055/a-1395-7485. Epub 2021 Apr 15.

publisher_dissemination: Georg Thieme

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility: Groupe Hospitalier Diaconesses - La Croix Saint-Simon

intervention_type: Procedure


title: LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens

acronym: LUCSO

summary:
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

Screening activity indicator: screening coverage rate over two years
Test quality indicator: validity of self-administered questionnaires to target the high-risk population
Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).

In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).

The trial will be conducted in several steps:

Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
Evaluation of occupational exposure to lung carcinogens
Evaluation of the lung cancer risk level and verification of eligibility
Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

ReferenceCitation: Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaid C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pelissier S, Pairon JC. LUCSO-1-French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol. BMJ Open. 2019 Mar 23;9(3):e025026. doi: 10.1136/bmjopen-2018-025026.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Centre Hospitalier Régional et Universitaire de Brest

collaborators: Centre Hospitalier Universitaire de Rouen

collaborators: Direction Centrale du Service de Santé des Armées

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial

acronym: MONTSAS

summary: This study compares the effect of Montelukast vs Placebo on Flow Mediated Dilatation of the Brachial Artery (FMD) in patients with obstructive sleep apnea syndrome.

ReferenceCitation: Ingelsson E, Yin L, Back M. Nationwide cohort study of the leukotriene receptor antagonist montelukast and incident or recurrent cardiovascular disease. J Allergy Clin Immunol. 2012 Mar;129(3):702-707.e2. doi: 10.1016/j.jaci.2011.11.052. Epub 2012 Jan 12.

ReferenceCitation: Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

ReferenceCitation: Cereza G, Garcia Dolade N, Laporte JR. Nightmares induced by montelukast in children and adults. Eur Respir J. 2012 Dec;40(6):1574-5. doi: 10.1183/09031936.00092812. No abstract available.

ReferenceCitation: Marchand MS, Jonville-Bera AP, Autret-Leca E; Association francaise des centres regionaux de pharmacovigilance. [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch Pediatr. 2013 Mar;20(3):269-73. doi: 10.1016/j.arcped.2012.12.006. Epub 2013 Feb 1. French.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Act For Chronic Diseases
Direction Générale de l'Offre de Soins

location_facility:
Métropole Savoie Hospital
Annecy Genevois Hospital
University Hospital Grenoble
University Hospital

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: MontSAS

titre: Impact du blocage de la voie des cysteinyl leucotriènes sur la fonction endothéliale des patients présentant un syndrome d'apnées obstructives du sommeil: essai en cross-over multicentrique randomisé contrôlé versus placebo.

discipline_principale: hors cancer

nom_porteur: DOUTRELEAU

prenom_porteur: Stéphane


title: Randomized Controlled Multicenter Prospective Open-label Study of the Efficacy of the Percutaneous Cryotherapy Combined or Not With a Medical Analgesia in the Treatment of Patients With Uncontrolled Painful Musculoskeletal Metastasis

acronym: CRYO

summary: The primary objective of this trial is to compare the efficacy of 2 analgesic strategies, based on percutaneous cryotherapy plus medical supportive care versus medical supportive care alone in the treatment of cancer patients with painful musculoskeletal metastasis.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de Montpellier-Val d'Aurelle

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

appel_a_projets: PHRCK

nom_etablissement: CENTRE LEON BERARD

type_etablissement: CLCC

titre: CRYOANALGESIE 01 - Etude randomisée contrôlée, multicentrique, prospective, en ouvert, évaluant  l'efficacité de la cryothérapie en association avec une analgésie médicamenteuse versus une analgésie médicamenteuse seule dans la prise en charge des patients porteurs de métastases douloureuses non contrôlées

discipline_principale: cancer

nom_porteur: MASTIER

prenom_porteur: Charles


title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™

acronym: ECRO

summary:
Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.

The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.

ReferenceCitation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

sponsor_collaborators:
Hospices Civils de Lyon
Baxter Healthcare Corporation

location_facility: Anesthesia and Critical Care Medicine Department - Edouard Herriot Hospital

location_facility: Hôpital Pasteur 2 - Hôpital Universitaire de Nice

location_facility: L'Hôpital Nord-Ouest - Villefranche sur Saone

location_facility: Hopital Universitaire de Clermont Ferrand


title: Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis

summary:
The Impact of cystic fibrosis (CF) on psychological and emotional functioning has been the focus of several studies over the past 20 years. The results from a current meta-analysis indicated that depressed patients were three times more likely to be noncompliant with treatment recommendations than nondepressed patients with chronic illness.

To date, most studies of the prevalence of psychiatric symptoms have been limited by small sample size; reliance on samples of convenience that are potentially biased in term of rates of symptomatology, and measures that contain legitimate symptoms that are part of the respondent's chronic disease. Estimating the prevalence of depression and anxiety has become important as new evidence indicates that these symptoms may have a significant impact on health outcomes, including adherence to medical treatments, utilization of health care services, and rates of morbidity and mortality. More depressive the symptoms are associated with poorer lung function, and that in the absence of depression, poor lung function is minimally associated with lower patient ratings of quality of life.

The purpose of the current study is to estimate the regional, and if possible the national prevalence of depressive and anxious symptoms in children and adults with CF and parents caregivers. Patients with CF ages 14 to 17, and parents of children ages 14 to 17, will complete and depression/anxiety screening measure at a routine clinic visit. These will then be linked with demographic and medical variables reported to the CF registry and analyzed cross sectionally. Adults with CF ages 18 and older will also complete the depression / anxiety screening measure at a routine clinic visit. Efforts will be made to recruit a representative sample of patients from each clinic.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose

location_facility: CRCM / Service de Pédiatrie _ Hôpital de Clocheville - CHRU de Tours

location_facility: CRCM - Service de Pédiatrie A - American Memorial Hospital

location_facility: CRCM - Service de Pneumologie Pédiatrique - CHU Amiens - Site Sud

location_facility: CRCM - Service de Pédiatrie - Pôle FEH - CHU Caen)

location_facility: CRCM / Service de Médecine Infantile - Hôpital d'Enfants - CHRU Nancy

location_facility: CRCM Enfants - Service de Pneumologie - Hôpital Jean Minjoz

location_facility: Department of Pneumology - CRCM- Necker - Enfants malades Hospital (AP-HP) -


title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study

acronym: EMMIE

summary: The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.

lead_sponsor: Symatese Aesthetics

sponsor_collaborators:
Symatese Aesthetics
MedPass International

location_facility:
Chu Pasteur
Clinique BIZET
Institut Gustave Roussy
Centre F.X. Michelet Chu Bordeaux
Hopital Tenon
Institut du Sein
Clinique des Champs Elysées
Clinique Charcot


title: Detection and Characteristic of Whipple Diseases in the Great Britany

acronym: WHO

summary:
Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma.

Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.

None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis.

As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.

lead_sponsor: University Hospital, Brest

location_facility:
CH le MAns
CH d'ORLEANS
CHRU de Brest
CHU de POITIERS
CHU de Tours
CHU d'ANGERS
CHU de Rennes
CHU de Nantes


title: Interest of iRECIST Radiological Assessment for Disease Control Rate (DCR) for Evaluation of Patients With Metastatic Colorectal Cancer dMMR and/or MSI Treated With Nivolumab and Ipilimumab. A GERCOR Open-label Phase II Study NIPICOL C17-01

acronym: NIPICOL

summary:
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks.

Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators).

A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.

ReferenceCitation: Ratovomanana T, Cohen R, Svrcek M, Renaud F, Cervera P, Siret A, Letourneur Q, Buhard O, Bourgoin P, Guillerm E, Dorard C, Nicolle R, Ayadi M, Touat M, Bielle F, Sanson M, Le Rouzic P, Buisine MP, Piessen G, Collura A, Flejou JF, de Reynies A, Coulet F, Ghiringhelli F, Andre T, Jonchere V, Duval A. Performance of Next-Generation Sequencing for the Detection of Microsatellite Instability in Colorectal Cancer With Deficient DNA Mismatch Repair. Gastroenterology. 2021 Sep;161(3):814-826.e7. doi: 10.1053/j.gastro.2021.05.007. Epub 2021 May 13.

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

repositories_concat: HAL

publisher_dissemination: Elsevier

ReferenceCitation: Cohen R, Bennouna J, Meurisse A, Tournigand C, De La Fouchardiere C, Tougeron D, Borg C, Mazard T, Chibaudel B, Garcia-Larnicol ML, Svrcek M, Vernerey D, Menu Y, Andre T. RECIST and iRECIST criteria for the evaluation of nivolumab plus ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the GERCOR NIPICOL phase II study. J Immunother Cancer. 2020 Nov;8(2):e001499. doi: 10.1136/jitc-2020-001499.

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Henri Mondor Hospital
Centre Leon Berard
CHU Nantes - Hôtel Dieu
IHFB
CHU Poitiers
CHRU Besançon
Institut Sainte Catherine
Hospital Saint Antoine


title: Observational Prospective Multicentered Study Evaluating Initial Clinical Presentation of Inflammatory Optic Neuritis (ON) Associated or Not With Autoantibodies Anti- Myelin-oligodendrocyte-glycoprotein (MOG-Ab)

acronym: MOG

summary: In eight ophthalmic units, the investigator will include all inflammatory optic neuritis (ON) during acute phase and rank them in two groups: 1/ ON with autoantibodies anti-myelin-oligodendrocyte-glycoprotein (ON MOG+) 2/ ON MOG-. The investigators will measure incidence of MOG-Ab in our prospective population of inflammatory ON. Then the investigator will compare clinical and radiological presentation of ON MOG+ versus ON MOG-.

ReferenceCitation: Ramanathan S, Dale RC, Brilot F. Anti-MOG antibody: The history, clinical phenotype, and pathogenicity of a serum biomarker for demyelination. Autoimmun Rev. 2016 Apr;15(4):307-24. doi: 10.1016/j.autrev.2015.12.004. Epub 2015 Dec 17.

ReferenceCitation: Akaishi T, Nakashima I, Takeshita T, Kaneko K, Mugikura S, Sato DK, Takahashi T, Nakazawa T, Aoki M, Fujihara K. Different etiologies and prognoses of optic neuritis in demyelinating diseases. J Neuroimmunol. 2016 Oct 15;299:152-157. doi: 10.1016/j.jneuroim.2016.09.007. Epub 2016 Sep 14.

ReferenceCitation: Ramanathan S, Reddel SW, Henderson A, Parratt JD, Barnett M, Gatt PN, Merheb V, Kumaran RY, Pathmanandavel K, Sinmaz N, Ghadiri M, Yiannikas C, Vucic S, Stewart G, Bleasel AF, Booth D, Fung VS, Dale RC, Brilot F. Antibodies to myelin oligodendrocyte glycoprotein in bilateral and recurrent optic neuritis. Neurol Neuroimmunol Neuroinflamm. 2014 Oct 29;1(4):e40. doi: 10.1212/NXI.0000000000000040. eCollection 2014 Dec.

ReferenceCitation: Havla J, Kumpfel T, Schinner R, Spadaro M, Schuh E, Meinl E, Hohlfeld R, Outteryck O. Myelin-oligodendrocyte-glycoprotein (MOG) autoantibodies as potential markers of severe optic neuritis and subclinical retinal axonal degeneration. J Neurol. 2017 Jan;264(1):139-151. doi: 10.1007/s00415-016-8333-7. Epub 2016 Nov 14.

ReferenceCitation: Sato DK, Callegaro D, Lana-Peixoto MA, Waters PJ, de Haidar Jorge FM, Takahashi T, Nakashima I, Apostolos-Pereira SL, Talim N, Simm RF, Lino AM, Misu T, Leite MI, Aoki M, Fujihara K. Distinction between MOG antibody-positive and AQP4 antibody-positive NMO spectrum disorders. Neurology. 2014 Feb 11;82(6):474-81. doi: 10.1212/WNL.0000000000000101. Epub 2014 Jan 10.

ReferenceCitation: Jarius S, Ruprecht K, Kleiter I, Borisow N, Asgari N, Pitarokoili K, Pache F, Stich O, Beume LA, Hummert MW, Ringelstein M, Trebst C, Winkelmann A, Schwarz A, Buttmann M, Zimmermann H, Kuchling J, Franciotta D, Capobianco M, Siebert E, Lukas C, Korporal-Kuhnke M, Haas J, Fechner K, Brandt AU, Schanda K, Aktas O, Paul F, Reindl M, Wildemann B; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 2: Epidemiology, clinical presentation, radiological and laboratory features, treatment responses, and long-term outcome. J Neuroinflammation. 2016 Sep 27;13(1):280. doi: 10.1186/s12974-016-0718-0.

ReferenceCitation: Hoftberger R, Sepulveda M, Armangue T, Blanco Y, Rostasy K, Calvo AC, Olascoaga J, Ramio-Torrenta L, Reindl M, Benito-Leon J, Casanova B, Arrambide G, Sabater L, Graus F, Dalmau J, Saiz A. Antibodies to MOG and AQP4 in adults with neuromyelitis optica and suspected limited forms of the disease. Mult Scler. 2015 Jun;21(7):866-874. doi: 10.1177/1352458514555785. Epub 2014 Oct 24.

ReferenceCitation: The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.

ReferenceCitation: Stiebel-Kalish H, Lotan I, Brody J, Chodick G, Bialer O, Marignier R, Bach M, Hellmann MA. Retinal Nerve Fiber Layer May Be Better Preserved in MOG-IgG versus AQP4-IgG Optic Neuritis: A Cohort Study. PLoS One. 2017 Jan 26;12(1):e0170847. doi: 10.1371/journal.pone.0170847. eCollection 2017.

ReferenceCitation: Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.

ReferenceCitation: Elsone L, Panicker J, Mutch K, Boggild M, Appleton R, Jacob A. Role of intravenous immunoglobulin in the treatment of acute relapses of neuromyelitis optica: experience in 10 patients. Mult Scler. 2014 Apr;20(4):501-4. doi: 10.1177/1352458513495938. Epub 2013 Aug 28.

ReferenceCitation: Optic Neuritis Study Group. Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology. 2008 Jun;115(6):1079-1082.e5. doi: 10.1016/j.ophtha.2007.08.004. Epub 2007 Nov 5.

ReferenceCitation: Garcia-Martin E, Ara JR, Martin J, Almarcegui C, Dolz I, Vilades E, Gil-Arribas L, Fernandez FJ, Polo V, Larrosa JM, Pablo LE, Satue M. Retinal and Optic Nerve Degeneration in Patients with Multiple Sclerosis Followed up for 5 Years. Ophthalmology. 2017 May;124(5):688-696. doi: 10.1016/j.ophtha.2017.01.005. Epub 2017 Feb 7.

ReferenceCitation: Beck RW, Gal RL, Bhatti MT, Brodsky MC, Buckley EG, Chrousos GA, Corbett J, Eggenberger E, Goodwin JA, Katz B, Kaufman DI, Keltner JL, Kupersmith MJ, Miller NR, Moke PS, Nazarian S, Orengo-Nania S, Savino PJ, Shults WT, Smith CH, Trobe JD, Wall M, Xing D; Optic Neuritis Study Group. Visual function more than 10 years after optic neuritis: experience of the optic neuritis treatment trial. Am J Ophthalmol. 2004 Jan;137(1):77-83. doi: 10.1016/s0002-9394(03)00862-6. Erratum In: Am J Ophthalmol. 2004 Apr;137(4):following 793. Am J Ophthalmol. 2004 Aug;138(2):following 321.

ReferenceCitation: Pache F, Zimmermann H, Mikolajczak J, Schumacher S, Lacheta A, Oertel FC, Bellmann-Strobl J, Jarius S, Wildemann B, Reindl M, Waldman A, Soelberg K, Asgari N, Ringelstein M, Aktas O, Gross N, Buttmann M, Ach T, Ruprecht K, Paul F, Brandt AU; in cooperation with the Neuromyelitis Optica Study Group (NEMOS). MOG-IgG in NMO and related disorders: a multicenter study of 50 patients. Part 4: Afferent visual system damage after optic neuritis in MOG-IgG-seropositive versus AQP4-IgG-seropositive patients. J Neuroinflammation. 2016 Nov 1;13(1):282. doi: 10.1186/s12974-016-0720-6.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
Chu Angers
Ch Challans
Ch Cholet
Ch Saint Nazaire
Chr Le Mans
Chd La Roche Sur Yon
Ch Laval


title: Protection During Cardiac Surgery.

acronym: ProCCard

summary: This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

ReferenceCitation: Chiari P, Mewton N, Maucort-Boulch D, Desebbe O, Durand M, Fischer MO, Lena-Quintard D, Palao JC, Ovize M, Fellahi JL. Multimodal Strategy for Myocardial Protection During Cardiac Surgery: The ProCCard Study. J Am Coll Cardiol. 2021 Feb 16;77(6):827-829. doi: 10.1016/j.jacc.2020.12.020. No abstract available.

ReferenceCitation: Chiari P, Durand M, Desebbe O, Fischer MO, Lena-Quintard D, Palao JC, Mercier C, Samson G, Varillon Y, Pozzi M, Mewton N, Maucort-Boulch D, Ovize M, Fellahi JL. Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial. Trials. 2019 Sep 11;20(1):560. doi: 10.1186/s13063-019-3638-3.

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut Arnault Tzanck - Saint-Laurent du Var

location_facility: Unité de Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

location_facility: service de Chirurgie Cardiaque CHU Gabriel Montpied

location_facility: Service d'Anesthésie-Réanimation, Hôpital Cardiologique et Pneumologique Louis Pradel

acronyme: ProCCard

titre: Protection per-opératoire en Chirurgie Cardiaque

nom_porteur: FELLAHI

prenom_porteur: Jean-Luc


title: COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction, a Phase II, Multicenter, Randomized, Double Blinded, Placebo Controlled Clinical Trial

acronym: COVERT-MI

summary:
Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury in ST-segment elevation myocardial infarction. They add additional damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. All the different anti-inflammatory approaches to reduce reperfusion injury have been disappointing.

Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase release) with a short course treatment of colchicine in comparison to placebo.

One mechanism to explain this effect could be the reduction of adverse left ventricular (LV) remodelling. LV remodelling is part of the healing process of myocardium after MI. It is defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV remodelling is increased by inflammation and ultimately leads to heart failure.

Our main hypothesis is that colchicine with its anti-inflammatory properties significantly reduces the initiation of adverse LV remodelling, together with a significant reduction of infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients referred for PPCI.

After inclusion and randomisation, patients will receive the first part of their experimental treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5 days. They will be followed up during their hospitalization and until one year. In order to evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during their participation: one during their hospitalization and a second at 3 months. At 1 year, adverse events will be collected by phone.

ReferenceCitation: Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

publisher_dissemination: Wolters Kluwer Health

location_facility:
CHU Arnaud de Villeneuve
Centre Hospitalier Universitaire Angers
CHU de Poitiers
CHU de Mulhouse
CHRU de Tours
Hôpital Saint Joseph
Hôpital Louis Pradel
CHU de Rangueil

acronyme: COVERT MI

titre: Colchicine comme traitement du remodelage ventriculaire gauche dans l'infarctus aiguë du myocarde.

discipline_principale: cardiologie

nom_porteur: MEWTON

prenom_porteur: Nathan


title: Non Invasive Prenatal Diagnosis on Isolated Circulating Fetal Trophoblastic Cells (CFTC) for Triplet Repeat Diseases

acronym: DIACCIMEX

summary: The purpose of this study is to develop and validate an analytical and clinical NIPD test for triplet repeat diseases by isolated circulating fetal trophoblastic cells (CFTC) analysis from maternal blood, searching for the familial mutation in families at risk of having one of the following triplet repeat diseases: Huntington's disease, Steinert Myotonic dystrophy, Fragile X syndrome, spinocerebellar ataxia (SCA) 1, 2 and 3.

primary_purpose: Diagnostic

ReferenceCitation: Cayrefourcq L, Vincent MC, Pierredon S, Moutou C, Imbert-Bouteille M, Haquet E, Puechberty J, Willems M, Liautard-Haag C, Molinari N, Zordan C, Dorian V, Rooryck-Thambo C, Goizet C, Chaussenot A, Rouzier C, Boureau-Wirth A, Monteil L, Calvas P, Miry C, Favre R, Petrov Y, Khau Van Kien P, Le Boette E, Fradin M, Alix-Panabieres C, Guissart C. Single Circulating Fetal Trophoblastic Cells Eligible for Non Invasive Prenatal Diagnosis: the Exception Rather than the Rule. Sci Rep. 2020 Jun 17;10(1):9861. doi: 10.1038/s41598-020-66923-9.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier
CHU Toulouse
CHU Nîmes
CH Saint Brieuc
CHU Nice
CHU Rennes
CHU Bordeaux
CHU Strasbourg

intervention_type: Genetic

region: Occitanie

nom_etablissement: CHU MONTPELLIER

acronyme: DIACCIMEX

titre: DIagnostic Anté-natal sur Cellules foetales trophoblastiques CIrculantes (CFTC) de Maladies à EXpansions de triplets à partir de sang maternel

discipline_principale: diagnostic prénatal des maladies neurodégénératives

nom_porteur: VINCENT

prenom_porteur: Marie-Claire


title: Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months

acronym: DexEnceph

summary:
Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV).

HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. It is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with HSV encephalitis. The aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with HSV Encephalitis.

ReferenceCitation: Whitley RJ. Herpes simplex encephalitis: adolescents and adults. Antiviral Res. 2006 Sep;71(2-3):141-8. doi: 10.1016/j.antiviral.2006.04.002. Epub 2006 Apr 25.

ReferenceCitation: Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15. Erratum In: Lancet Infect Dis. 2011 Feb;11(2):79.

ReferenceCitation: Tunkel AR, Glaser CA, Bloch KC, Sejvar JJ, Marra CM, Roos KL, Hartman BJ, Kaplan SL, Scheld WM, Whitley RJ; Infectious Diseases Society of America. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2008 Aug 1;47(3):303-27. doi: 10.1086/589747.

sponsor_collaborators:
University Hospital, Grenoble
University of Liverpool

location_facility:
CHRU de Nancy, Hopitaux de Brabois
Hôpital Gui de Chauliac
CHU Strasbourg
CHU Hôtel-Dieu
Hôpital Bichat-Claude Bernard, APHP
CHU Rennes, Hôpital Pontchaillou
Hôpital Charles Nicolle
Hôpital Delafontaine

acronyme: DEX Enceph

titre: Traitement par Dexamethasone des encéphalites à Herpes Simplex Virus (HSV). Essai contrôlé randomisé

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: STAHL

prenom_porteur: Jean Paul


title: Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.

acronym: QUANARIE

summary:
Physician mainly use RECIST progression-free survival (PFS) and NCI CTCAE safety as a guide to evaluate treatment efficiency. In contrast Health Related Quality of Life (HRQOL) assessment is often restricted to clinical trial. It could be of particular interest to evaluate HRQOL in daily clinical practice in order to adequately choose and manage first line therapy, especially since HRQOL at diagnosis was shown to be a prognostic factor of overall survival in advanced or metastatic renal cell carcinoma (mRCC). A systematic collection in daily clinical practice of the HRQoL data using standardized questionnaires could strengthen management of symptoms : improve symptom control, improve patient-clinician communication, satisfaction with care and well-being of the patient and in fine the overall survival.

The objective of the QUANARIE Study is to assess the use of HRQOL assessment in daily clinical practice for patients with mRCC treated with tyrosine kinase inhibitor (TKI) using electronic patient reported outcome (PRO).

Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to clinicians, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on patient reported outcomet.

ReferenceCitation: Mouillet G, Fritzsch J, Paget-Bailly S, Pozet A, Es-Saad I, Meurisse A, Vernerey D, Mouyabi K, Berthod D, Bonnetain F, Anota A, Thiery-Vuillemin A. Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol. Health Qual Life Outcomes. 2019 Feb 4;17(1):25. doi: 10.1186/s12955-019-1085-1.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre de lutte contre le cancer Jean Godinot

location_facility: Centre de lutte contre le cancer Alexis Vautrin - Institut de Cancérologie de Lorraine

location_facility: Centre de lutte contre le cancer Georges François Leclerc

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

acronyme: QUANARIE

titre: Recueil en routine de la qualité de vie relative à la santé (QdV) des patients atteints d'un cancer du rein métastatique (CRM) traités par inhibiteur de tyrosine kinase (TKI) grâce aux nouvelles technologies au sein de l'interregion nord-est

nom_porteur: MOUILLET

prenom_porteur: Guillaume


title: Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

summary:
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.

The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.

lead_sponsor: Oticon Medical

location_facility:
CHU Bordeaux Pellegrin
CHU Lyon Hôpital Edouard Herriot
APHM - Hôpital Nord Marseille
CHU Rennes Pontchaillou
IUFC - CHU Nice
APHP Pitie salpetriere
CHRU de Nancy hôpital Central
CHRU Lille Hôpital Roger Salengro


acronym: PROMET

lead_sponsor: Swiss Group for Clinical Cancer Research

summary: The main objective of the trial is to explore the efficacy of salvage radiotherapy (SRT) plus metformin compared to SRT in the endpoint of time to progression after prostatectomy failure.

location_facility: Centre de lutte contre le cancer Léon Bérard

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Centre Hospitalier Régional Universitaire (CHRU) Jean Minjoz

location_facility: Clinique Pasteur - Centre finistérien de radiothérapie et d'oncologie

location_facility: EOC-Istituto Oncologico della Svizzera Italiana

location_facility: Institut de Cancérologie de L'Ouest René Gauducheau

title: SAKK 08/15 - PROMET - Multicenter, Randomized Phase II Trial of Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy

location_country: Germany Switzerland France


title: Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto

acronym: PoP IN VAuto

summary: Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

lead_sponsor: ResMed

location_facility:
Cabinet de Pneumologie
Clinique Aguilera
Polyclinique Saint-Laurent
HCL - Croix-Rousse Hospital
Centre médical du sommeil
CH de Belfort
Hopital Saint Antoine
APHM


title: AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment

acronym: ANTICIPATE

summary:
During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats.

Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size.

Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes.

In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.

ReferenceCitation: van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodriguez-Bano J, Herghea D, Cornely OA, Biehl LM, Bernard L, Dominguez-Luzon MA, Maraki S, Barraud O, Nica M, Jazmati N, Sablier-Gallis F, de Gunzburg J, Mentre F, Malhotra-Kumar S, Bonten MJM, Vehreschild MJGT; ANTICIPATE Study Group. Incidence and predictive biomarkers of Clostridioides difficile infection in hospitalized patients receiving broad-spectrum antibiotics. Nat Commun. 2021 Apr 14;12(1):2240. doi: 10.1038/s41467-021-22269-y.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Universidad de Sevilla - idUS

ReferenceCitation: Berkell M, Mysara M, Xavier BB, van Werkhoven CH, Monsieurs P, Lammens C, Ducher A, Vehreschild MJGT, Goossens H, de Gunzburg J, Bonten MJM, Malhotra-Kumar S; ANTICIPATE study group. Microbiota-based markers predictive of development of Clostridioides difficile infection. Nat Commun. 2021 Apr 14;12(1):2241. doi: 10.1038/s41467-021-22302-0.

ipd_sharing_description: 16S rRNA and shotgun metagenomic sequence data generated and analyzed in this study have been deposited in the NCBI Sequence Read Archive with the accession code PRJNA685914. Human reads were identified and removed prior to shotgun metagenomics data upload. Access to clinical data is restricted as the informed consent provided does not allow for use of clinical data outside the research institution. Data are available from the corresponding author upon reasonable requests.

lead_sponsor: MJM Bonten

sponsor_collaborators:
MJM Bonten
Da Volterra
Universitätsklinikum Köln
Universiteit Antwerpen

location_country: Germany Romania Netherlands Spain Greece France

location_facility: Clinical Hospital Of Infectious Diseases Of Iasi

location_facility: Cluj Napoca Infectious disease Clinical Hospital

location_facility: The National Institute of Infectious Diseases Matei Bals

location_facility: Infectious and Tropical Diseases Hospital "Dr. Victor Babes"

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Oncology Institute Ion Chiricuta Cluj Napoca


title: Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

acronym: PRINGEN

summary:
Despite a large diffusion for generic anti-hypertensive, they are not currently used.

Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only.

A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria.

The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
CH du PUY EN VELAY
CH de SAINT-CHAMOND
CH de FEURS
CH d'ANNONAY
CH de FIRMINY
CH de ROANNE
CH de MONTBRISON