acronym: TOBRAMUC

title: Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

location_facility: CRCM mixte - CHU de Caen Hôpital Côte de Nacre

location_facility: CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres

location_facility: CRCM mixte - CHU de Rouen Hôpital Charles Nicolle

location_facility: CRCM pédiatrique - CHU d'Amiens Hôpital Nord

location_facility: CRCM adulte - CHRU de Lille Hôpital Calmette

summary: The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.


title: Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study

acronym: REPLAY

summary: Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Merdrignac A, Garnier J, Dokmak S, Regenet N, Lesurtel M, Mabrut JY, Sa Cunha A, Fuks D, Bergeat D, Robin F, Le Pabic E, Boudjema K, Turrini O, Laviolle B, Sulpice L. Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula After Distal Pancreatectomy: Results of the REPLAY (REinforcement of the Pancreas in distaL pAncreatectomY) Multicenter Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):769-775. doi: 10.1097/SLA.0000000000005618. Epub 2022 Jul 25.

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: Service de chirurgie Hépato-pancréato-biliaire

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou

location_facility: AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive

location_facility: Service de chirurgie générale, digestive et de la transplantation hépatique

location_facility: Service de chirurgie digestive et endocrienne

location_facility: Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer

acronym: CHIMOVIP

summary: CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

status: Recruiting

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

intervention_type: Drug


title: A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

acronym: NIVOREN

summary: The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Rassy E, Dalban C, Colomba E, Derosa L, Alves Costa Silva C, Negrier S, Chevreau C, Gravis G, Oudard S, Laguerre B, Barthelemy P, Goupil MG, Geoffrois L, Rolland F, Thiery-Vuillemin A, Joly F, Ladoire S, Tantot F, Escudier B, Albiges L. Efficacy and Safety of Concomitant Proton Pump Inhibitor and Nivolumab in Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. Clin Genitourin Cancer. 2022 Oct;20(5):488-494. doi: 10.1016/j.clgc.2022.07.003. Epub 2022 Jul 10.

ReferenceCitation: Billon E, Chanez B, Rochigneux P, Albiges L, Vicier C, Pignot G, Walz J, Chretien AS, Gravis G, Olive D. Soluble BTN2A1 Is a Potential Prognosis Biomarker in Pre-Treated Advanced Renal Cell Carcinoma. Front Immunol. 2021 Apr 20;12:670827. doi: 10.3389/fimmu.2021.670827. eCollection 2021.

ReferenceCitation: Flippot R, Dalban C, Laguerre B, Borchiellini D, Gravis G, Négrier S, Chevreau C, Joly F, Geoffrois L, Ladoire S, Mahammedi H, Rolland F, Gross-Goupil M, Deluche E, Priou F, Laramas M, Barthélémy P, Narciso B, Houedé N, Culine S, Oudard S, Chenot M, Tantot F, Chabaud S, Escudier B, Albiges L. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019 Aug 10;37(23):2008-2016. doi: 10.1200/JCO.18.02218. Epub 2019 Jun 13.

lead_sponsor: UNICANCER

location_facility: Gustave Roussy Cancer Campus Grand Paris

lead_sponsor_type: industriel

status_simplified: Completed


title: Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients

acronym: LUPUS

summary: Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Chu de Brest
Hopital Pellegrin
Hopital Pontchaillon - Chu de Rennes
CHR d'Orléans
Chru de Tours
CH du MANS
CHU Hôtel Dieu

intervention_type: Other


title: Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

acronym: HYCOREMA

summary: The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
APHM La Timone
Centre Paul Strauss
Institut de Cancerologie de Lorraine
CH Bastia
CHRU de Brest
Centre Léon Bérard
Chu Bordeaux-Pellegrin

status_simplified: Unknown


title: Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

acronym: SCOLEVOL

summary: The hypothesis of this study is that progressive AIS is characterized by a disorder of orthostatic postural control. The analysis and the treatment of posturographic signal on computerized integrate force plates, coupled to clinical and radiographic examinations, could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the clinician in his therapeutic approach, based on the postural control improvement (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by corset). This method is non-invasive, without side effects, fast and achievable in routine care at the moment of the diagnosis of AIS.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Lille Catholic University

location_facility: Centre de MPR pour enfants de Bois Larris


type: Other Identifier

title: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

acronym: MICROPRUNG

summary:
Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.

primary_purpose: Basic Science

ReferenceCitation: Arnaud AP, Cousin I, Schmitt F, Petit T, Parmentier B, Levard G, Podevin G, Guinot A, DeNapoli S, Hervieux E, Flaum V, De Vries P, Randuineau G, David-Le Gall S, Buffet-Bataillon S, Boudry G. Different Fecal Microbiota in Hirschsprung's Patients With and Without Associated Enterocolitis. Front Microbiol. 2022 Jun 30;13:904758. doi: 10.3389/fmicb.2022.904758. eCollection 2022.

ipd_sharing_description: Case Report Form

location_facility:
Poitiers University Hospital
Caen Univeristy Hospital
Tours University Hospital
Brest University Hospital
Rennes University Hospital
Angers University Hospital
Nantes University Hospital


title: Influence de l'ORientation de la réponse LYmphocytaire Sur la Survenue de Complications athéromateuses après Transplantation rénale (étude ORLY-EST 2)

acronym: ORLY-Est

summary:
The incidence of atherosclerotic complications is increased after kidney transplantation. Traditional risk factors do not fully explain this increased risk. Atherosclerosis is an inflammatory disease in which all players in the immune response are involved. The impact of these immune responses is not well known in immunocompromised patients, particularly among organ transplant. Nevertheless, the work of our group suggest that innate and acquired responses through different mechanisms influencing the evolution of atheromatous disease after transplantation.

The investigators therefore propose to study the impact of the expansion of regulatory T cells on the risk of atherosclerotic complications after transplantation.

Since November 2008, the investigators began a multicenter, prospective study whose purpose is to study in detail the immunological mechanisms of atherosclerosis after transplantation via immunomonitoring cohort of renal transplant patients in the Grand East Interregion. It was planned to include 500 patients and to date a little more than half have been included. After completion of the blood test, the tubes are routed over the Biomonitoring Platform (CIC-BT 506 Besançon) and the samples are stored in CRB Dijon.

The atherosclerotic events are recorded prospectively. The investigators hope to implement as part of ORLY IS, a second study to determine the impact of an expansion of regulatory T cells on the risk of atherosclerotic events.

Our hypothesis is that a cell rate regulatory T below the median results in an increase of 5% of atherosclerotic complications.

ReferenceCitation: Ducloux D, Courivaud C, Bamoulid J, Crepin T, Gaiffe E, Laheurte C, Vauchy C, Rebibou JM, Saas P, Borot S. Immune phenotype predicts new onset diabetes after kidney transplantation. Hum Immunol. 2019 Nov;80(11):937-942. doi: 10.1016/j.humimm.2019.08.006. Epub 2019 Sep 10.

ReferenceCitation: Ducloux D, Legendre M, Bamoulid J, Rebibou JM, Saas P, Courivaud C, Crepin T. ESRD-associated immune phenotype depends on dialysis modality and iron status: clinical implications. Immun Ageing. 2018 Jul 17;15:16. doi: 10.1186/s12979-018-0121-z. eCollection 2018.

ipd_sharing: Yes

ipd_sharing_description: Identified individual participant data for all outcome measures will be made available within 6 monts of study completion

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHU Clermont-Ferrand, 58 rue Montalembert, 63003 Clermont-Ferrand

location_facility: CHU Reims, 45 rue Cognacq-Jay 51092 Reims Cedex

location_facility: Hôpital du Kremlin Bicêtre 78, rue du Général Leclerc, 94275 Le Kremlin-Bicêtre Cedex

location_facility: Hôpital Civil- 1, place de l'hôpital BP426 ; 67091 Strasbourg Cedex

location_facility: CHU Dijon, Hôpital du Bocage, 2 Bd du Maréchal de Lattre de Tassigny, 21079 Dijon cedex


title: Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient: Multicentre Randomized Trial

acronym: RENOMAP

summary: Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

lead_sponsor: University Hospital, Tours

location_facility: Coordination des prélèvements d'organes et de Tissus Pôle Anesthésie-Réanimations,University Hospital

location_facility: Coordination Hospitalière de PMO , Pôle USSAR-Anestéthésie -Réa CHU-ANGERS

location_facility: Coordination des prélèvements d'organes et de Tissus,CHU-NANTES

location_facility: Coordination Hospitalière de PMO-Anestésiste -réanimateur, CHU-Bordeaux -GROUPE HOSPITALIER PELLEGRIN DAR I

location_facility: Chirurgien-Chirurgie de la transplantation et d'Urologie, Pavillon V, Hôpital Edouard HERRIOT

location_facility: Coordination des prélèvements d'organes et de Tissus- CHU-Limoges -CHU- DUPUYTREN


title: Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

acronym: PhiNESS

summary: The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

location_facility:
Chu de Bordeaux
Ch de Libourne
Chu de Brest
Chu Angers
Ch de La Cöte Basque
Ch de Dax
Crlcc Bergonie

intervention_type: Biological


title: Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

type: EudraCT Number

source: euctr

ReferenceCitation: Marret G, Isambert N, Rezai K, Gal J, Saada-Bouzid E, Rolland F, Chausson M, Borcoman E, Alt M, Klijanienko J, Vansteene D, Guigay J, Kamal M, Bièche I, Le Tourneau C; UNICANCER Head, Neck Group. Phase I trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Invest New Drugs. 2021 Dec;39(6):1641-1648. doi: 10.1007/s10637-021-01152-z. Epub 2021 Jul 28.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

location_facility:
Centre Georges François Leclerc
Centre Antoine Lacassagne
Institut de Cancérologie de Lorraine
Institut de Cancérologie de l'Ouest
Centre Léon Bérard
Centre Oscar Lambret
Institut Curie

summary:
The study consists of two distinct and sequential parts:

A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination (copanlisib/cetuximab) and the RP2D
A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended Phase 2 Dose)

All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in association with Cetuximab.


title: Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)

acronym: SAB

summary: The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHRU Nancy
CHR Metz-Thionville- Mercy Hospital
Centre Hospitalier Emile Durkheim
CHU Dijon
Clinique Saint Francois
CHR METZ THIONVILLE- Bel-Air Hospital
CHRU Strasbourg


title: Phase 2 Gene Therapy Trial of Locally Advanced Pancreatic Adenocarcinoma Using Intratumoral Injection of CYL-02 in Combination With Gemcitabine

summary:
Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries, and its incidence has increased over the last 40 years. Curative surgery to manage PDAC is possible in only a fraction of patients; indeed, a vast majority (85%) of patients is diagnosed with locally advanced tumors and/or metastases because they lack specific symptoms and early markers for this disease. For these patients, palliative armamentarium consists of conventional chemotherapeutic agents such as Gemcitabine and, more recently, FOLFIRINOX, which offer marginal survival benefits. Consequently, the prognosis for PDAC is still very poor and there is great need for new treatments that can change this poor outcome. In this context, the investigators have devised, in the past few years, a highly innovative approach based on therapeutic gene transfer, which does not rely on a specific genetic and/or cellular background to inhibit PDAC tumor growth. the investigators found that SSTR2 and DCK::UMK gene transfer demonstrated complementary therapeutic effects to inhibit tumor progression and dissemination, and reduced tumor burden, respectively. On the basis of these promising preclinical data, the investigators conducted past three years the first clinical study of non-viral vector-mediated therapeutic gene delivery, guided by endoscopy (EUS), and combined with standard Gemcitabine therapy in patients with locally advanced and metastatic PDAC. The phase 1 demonstrated that the gene-therapy product CYL-02 is expressed in PDAC tumors (with long-lasting expression within tumor tissues), is distributed within the bloodstream in some extent, when combined with Gemcitabine it can inhibit primary-tumor progression and dissemination. Our results tend to demonstrate therapeutic efficacy, especially in patients with locally advanced tumors. Based on these encouraging results, the investigators propose that patients with locally advanced PDAC at the time of diagnosis may clinically benefit from this approach.

This phase II study is designed to compare the efficacy of intra-tumoral gene delivery of CYL-02 plus Gemcitabine treatment or Gemcitabine alone in patient with locally advanced PDAC.

lead_sponsor: University Hospital, Toulouse

location_facility:
APHP Hôpital Beaujon
Institut régional du Cancer
Rangueil Hospital
Institut Paoli Calmettes
CHU de Marseille Hôpital Nord
Institut Gustave Roussy
Hôpital privé Jean Mermoz


title: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)

summary: Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.

primary_purpose: Prevention

ReferenceCitation: Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.

lead_sponsor: Hospices Civils de Lyon

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


title: Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative

acronym: THEODORA

summary: THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A & MS bioassays on tumor control by radiotherapy.

ReferenceType: background

ReferenceCitation: Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. Erratum in: Cancer. 2006 Aug 1;107(3):660.

ReferenceCitation: Bentzen SM, Heeren G, Cottier B, Slotman B, Glimelius B, Lievens Y, van den Bogaert W. Towards evidence-based guidelines for radiotherapy infrastructure and staffing needs in Europe: the ESTRO QUARTS project. Radiother Oncol. 2005 Jun;75(3):355-65. Epub 2005 Mar 16.

ReferenceCitation: Lievens Y, Grau C. Health economics in radiation oncology: introducing the ESTRO HERO project. Radiother Oncol. 2012 Apr;103(1):109-12. doi: 10.1016/j.radonc.2011.12.026. Epub 2012 Feb 8.

ReferenceCitation: Dörr W, Hendry JH. Consequential late effects in normal tissues. Radiother Oncol. 2001 Dec;61(3):223-31. Review.

ReferenceCitation: Bodgi L, Granzotto A, Devic C, Vogin G, Lesne A, Bottollier-Depois JF, Victor JM, Maalouf M, Fares G, Foray N. A single formula to describe radiation-induced protein relocalization: towards a mathematical definition of individual radiosensitivity. J Theor Biol. 2013 Sep 21;333:135-45. doi: 10.1016/j.jtbi.2013.05.020. Epub 2013 Jun 2.

ReferenceCitation: Foray N, Colin C, Bourguignon M. 100 years of individual radiosensitivity: how we have forgotten the evidence. Radiology. 2012 Sep;264(3):627-31. doi: 10.1148/radiol.12112560.

ReferenceCitation: Joubert A, Zimmerman KM, Bencokova Z, Gastaldo J, Chavaudra N, Favaudon V, Arlett CF, Foray N. DNA double-strand break repair defects in syndromes associated with acute radiation response: at least two different assays to predict intrinsic radiosensitivity? Int J Radiat Biol. 2008 Feb;84(2):107-25. doi: 10.1080/09553000701797039.

ReferenceCitation: Granzotto A, Joubert A, Viau M, Devic C, Maalouf M, Thomas C, Vogin G, Malek K, Colin C, Balosso J, Foray N. [Individual response to ionising radiation: What predictive assay(s) to choose?]. C R Biol. 2011 Feb;334(2):140-57. doi: 10.1016/j.crvi.2010.12.018. Review. French.

ReferenceCitation: Rothkamm K, Löbrich M. Evidence for a lack of DNA double-strand break repair in human cells exposed to very low x-ray doses. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5057-62. Epub 2003 Apr 4.

ReferenceCitation: COPERNIC project investigators, Granzotto A, Benadjaoud MA, Vogin G, Devic C, Ferlazzo ML, Bodgi L, Pereira S, Sonzogni L, Forcheron F, Viau M, Etaix A, Malek K, Mengue-Bindjeme L, Escoffier C, Rouvet I, Zabot MT, Joubert A, Vincent A, Dalla Venezia N, Bourguignon M, Canat EP, d'Hombres A, Thébaud E, Orbach D, Stoppa-Lyonnet D, Radji A, Doré E, Pointreau Y, Bourgier C, Leblond P, Defachelles AS, Lervat C, Guey S, Feuvret L, Gilsoul F, Berger C, Moncharmont C, de Laroche G, Moreau-Claeys MV, Chavaudra N, Combemale P, Biston MC, Malet C, Martel-Lafay I, Laude C, Hau-Desbat NH, Ziouéche A, Tanguy R, Sunyach MP, Racadot S, Pommier P, Claude L, Baleydier F, Fleury B, de Crevoisier R, Simon JM, Verrelle P, Peiffert D, Belkacemi Y, Bourhis J, Lartigau E, Carrie C, De Vathaire F, Eschwege F, Puisieux A, Lagrange JL, Balosso J, Foray N. Influence of Nucleoshuttling of the ATM Protein in the Healthy Tissues Response to Radiation Therapy: Toward a Molecular Classification of Human Radiosensitivity. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):450-60. doi: 10.1016/j.ijrobp.2015.11.013. Epub 2015 Nov 14.

ReferenceCitation: Bodgi L, Foray N. The nucleo-shuttling of the ATM protein as a basis for a novel theory of radiation response: resolution of the linear-quadratic model. Int J Radiat Biol. 2016;92(3):117-31. doi: 10.3109/09553002.2016.1135260.

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ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Gérard A, Buyse M, Nordlinger B, Loygue J, Pène F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC). Ann Surg. 1988 Nov;208(5):606-14.

ReferenceCitation: Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40.

ReferenceCitation: Fleming FJ, Påhlman L, Monson JR. Neoadjuvant therapy in rectal cancer. Dis Colon Rectum. 2011 Jul;54(7):901-12. doi: 10.1007/DCR.0b013e31820eeb37. Review.

ReferenceCitation: Movsas B, Diratzouian H, Hanlon A, Cooper H, Freedman G, Konski A, Sigurdson E, Hoffman J, Meropol NJ, Weiner LM, Coia L, Lanciano R, Stein J, Kister D, Eisenberg B. Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer. Am J Clin Oncol. 2006 Oct;29(5):435-41.

ReferenceCitation: Wagman R, Minsky BD, Cohen AM, Guillem JG, Paty PP. Sphincter preservation in rectal cancer with preoperative radiation therapy and coloanal anastomosis: long term follow-up. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):51-7.

ReferenceCitation: Pisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. J Clin Oncol. 1996 Mar;14(3):859-68.

ReferenceCitation: Yang JC, Chang AE, Baker AR, Sindelar WF, Danforth DN, Topalian SL, DeLaney T, Glatstein E, Steinberg SM, Merino MJ, Rosenberg SA. Randomized prospective study of the benefit of adjuvant radiation therapy in the treatment of soft tissue sarcomas of the extremity. J Clin Oncol. 1998 Jan;16(1):197-203.

ReferenceCitation: Koshy M, Rich SE, Mohiuddin MM. Improved survival with radiation therapy in high-grade soft tissue sarcomas of the extremities: a SEER analysis. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):203-9. doi: 10.1016/j.ijrobp.2009.04.051. Epub 2009 Aug 11.

ReferenceCitation: Strander H, Turesson I, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in soft tissue sarcomas. Acta Oncol. 2003;42(5-6):516-31. Review.

ReferenceCitation: Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, Piovesan C, Dileo P, Torri V, Gronchi A, Casali PG. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology. 2009 May;251(2):447-56. doi: 10.1148/radiol.2512081403. Epub 2009 Mar 4.

ReferenceCitation: Stahl R, Wang T, Lindner LH, Abdel-Rahman S, Santl M, Reiser MF, Issels RD. Comparison of radiological and pathohistological response to neoadjuvant chemotherapy combined with regional hyperthermia (RHT) and study of response dependence on the applied thermal parameters in patients with soft tissue sarcomas (STS). Int J Hyperthermia. 2009 Jun;25(4):289-98. doi: 10.1080/02656730902873616.

ReferenceCitation: O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41.

ReferenceCitation: Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7.

ReferenceCitation: Ishikura S, Nihei K, Ohtsu A, Boku N, Hironaka S, Mera K, Muto M, Ogino T, Yoshida S. Long-term toxicity after definitive chemoradiotherapy for squamous cell carcinoma of the thoracic esophagus. J Clin Oncol. 2003 Jul 15;21(14):2697-702.

ReferenceCitation: Morota M, Gomi K, Kozuka T, Chin K, Matsuura M, Oguchi M, Ito H, Yamashita T. Late toxicity after definitive concurrent chemoradiotherapy for thoracic esophageal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):122-8. doi: 10.1016/j.ijrobp.2008.10.075. Epub 2009 Mar 26.

ReferenceCitation: Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1:122S-50S. doi: 10.2967/jnumed.108.057307. Review.

lead_sponsor: Centre Leon Berard

location_facility: Hopital Nord Ouest Villefranche Sur Saone

location_facility: ICL - Institut de Cancérologie de la Lorraine

intervention_type: Radiation


title: Dysfunctions of Human Muscle Stem Cells in Sepsis

acronym: DISCUSS

summary: Severe critical illness is often complicated by Intensive Care Unit - Acquired Weakness (ICU-AW), which is associated with increased in and post-ICU mortality, with delayed weaning from mechanical ventilation and with long-term functional. Several mechanisms have been incriminated in the pathophysiology of ICU-AW, but muscle regeneration has not been well investigated in this context, even though its involvement is suggested by the protracted functional consequences of ICU-AW. Recent data suggest that muscle regeneration could be impaired after sepsis, and that Mesenchymal Stem Cells (MSCs) treatment could improve the post-injury muscle recovery.

ReferenceCitation: Rocheteau P, Chatre L, Briand D, Mebarki M, Jouvion G, Bardon J, Crochemore C, Serrani P, Lecci PP, Latil M, Matot B, Carlier PG, Latronico N, Huchet C, Lafoux A, Sharshar T, Ricchetti M, Chrétien F. Sepsis induces long-term metabolic and mitochondrial muscle stem cell dysfunction amenable by mesenchymal stem cell therapy. Nat Commun. 2015 Dec 15;6:10145. doi: 10.1038/ncomms10145.

ReferenceCitation: Duceau B, Blatzer M, Bardon J, Chaze T, Giai Gianetto Q, Castelli F, Fenaille F, Duarte L, Lescot T, Tresallet C, Riou B, Matondo M, Langeron O, Rocheteau P, Chrétien F, Bouglé A. Using a multiomics approach to unravel a septic shock specific signature in skeletal muscle. Sci Rep. 2022 Nov 5;12(1):18776. doi: 10.1038/s41598-022-23544-8.

lead_sponsor: Institut Pasteur

location_facility: Hôpital Pitié Salpêtrière, Anesthésie et Réanimation, Institut de Cardiologie

location_facility: Hôpital Pitié Salpétrière, Salle de surveillance post-interventionnelle, Accueil des Polytraumatisés

location_facility: Hôpital Pitié Salpêtrière, Service de réanimation chirurgicale polyvalente

location_facility: Hopital Henri Mondor, Service de Réanimation chirurgicale polyvalente

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Générale, Viscérale et Endocrinienne

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-réanimation

location_facility: Hôpital Pitié Salpêtrière, Service de Chirurgie Hépatobiliaire et de Transplantation Hépatique

intervention_type: Procedure


title: Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis

acronym: HOPE

summary:
Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. Because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. Several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to FVIII/FIX levels. However there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional FVIII measurement.

The main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and FVIII levels in severe haemophilia patients and compare these two laboratory results with:

the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months
the number of additional FVIII units used in the last 6 months

This project requires no change in term of type of treatment : During the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage).

The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results

status: Unknown status

location_facility: CHU Dijon Bourgogne Hôpital François Mitterrand

location_facility: Unité d'Hémostase Clinique Centre Régional de Traitement des Hémophiles Centre de Référence de Maladies Hémorragiques Hôpital Cardiologique Louis Pradel


title: A Phase I-II Study of NBTXR3 Activated by Sterostatic Body Radiation Therapy (SBRT) In the Treatment of Liver Cancers

summary: The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.

lead_sponsor: Nanobiotix

location_facility:
Centre René Gauducheau
CHU de NANCY
Institut de Cancérologie de Loraine
CHU La Croix Rousse
Institut Gustave Roussy
Hôpital Haut-Lévêque
Centre Eugène Marquis


title: An Open Label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Anetumab Ravtansine in Subjects With Mesothelin-expressing Advanced Solid Cancers and Different Stages of Concurrent Hepatic or Renal Impairment

summary: To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment

design_allocation: Non-Randomized

lead_sponsor: Bayer

location_country:
France
Moldova, Republic of


title: Evaluation of the Implementation of a Clinical Pathway for Improving the Performance of Medical and Surgical Management of Hip Prosthesis Infections

acronym: OSCAR-PH

summary: The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

lead_sponsor: University Hospital, Grenoble

location_facility: Groupe Hospitalier Mutualiste de Grenoble.


title: Study of the Performance of Acute Stroke Management in the Rhône Area After Implementation of a Multi-action Program

acronym: STROKE 69

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. However, only a small percentage of patients access to thrombolysis on time. Various actions have been implemented since 2006 in the Rhone area as part of research projects and of the 2010-2014 national stroke action plan: training of health professionals involved in the stroke management, increase of public awareness through sensibilization campaigns, implementation of telemedicine and increase of the number of hospital beds dedicated to stroke (stroke units beds).

The main objective of the STROKE 69 study is to assess the impact of these actions on intra-hospital acute stroke management times in the Rhône area. The secondary objectives are to assess the impact of these actions on the rate and place of thrombolysis, the rate of post- thrombolysis hemorrhage, the rate of thrombectomies, mortality in the acute phase, at 3 and 12 months, the level of disability at 3 and 12 months, pre-hospital times, the number of calls to SAMU centre 15 (French mobile emergency medical services, equivalent to 911) and management channels.

The investigator will perform a prospective cohort study between 06/11/2015 and 06/06/2016 and data will be compared to data collected in a previous cohorts study, the AVC-69 cohort study (Porthault Chatard et al, Int J Stroke. 2012 Oct;7(7):E13), between 06/11/2006 and 06/06/2007, before the implementation of the actions in the Rhône area.

The cohort will be constituted of all consecutive patients treated for a stroke suspicion by the Rhône SAMU centre 15, or in one of the emergency unit or stroke unit of the Rhône area, and presenting a symptom-onset (the last time the patient was seen without deficit) less than 24 hours.

After collecting data in the acute phase, patients with a confirmed diagnosis of stroke or transient ischemic attack (TIA) will be followed for 12 months after their inclusion by telephone calls at 3 and 12 months to assess the level of disability and mortality.

AVC 69 study allowed us to include 1306 patients between 2006 to 2007, the investigator plan to include at least 1300 patients in the STROKE 69 cohort with approximately 1000 confirmed strokes or TIAs.

location_facility: Urgences et Réanimation Médicale et SAMU, Hôpital Edouard Herriot

location_facility: Department of stroke unit - Hospices Civils de Lyon


title: Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

summary: HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

location_facility:
DEMARCHI Martin
BENGRINE-LEVEVRE Leïla
KURTZ Jean-Emmanuel
GAVOILLE Céline
SAVOYE Aude-Marie
KALBACHER Elsa
LONGO Raphaelle


title: Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.

acronym: STIMCONE

summary:
Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure.

The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level.

In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation.

The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.

lead_sponsor: Nantes University Hospital

location_facility:
Lille University Hospital
Colmar Hospital
Hôpital Foch
Nantes Hospital
Clinic Catherine de Sienne
Bordeaux University Hospital
Lyon University Hospital


acronym: OAsIs

title: A Phase I/II Trial of Obinutuzumab, ABT-199 (GDC-0199) Plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma Patients

ReferenceCitation: Le Gouill S, Morschhauser F, Chiron D, Bouabdallah K, Cartron G, Casasnovas O, Bodet-Milin C, Ragot S, Bossard C, Nadal N, Herbaux C, Tessoulin B, Tchernonog E, Rossi C, McCulloch R, Gastinne T, Callanan MB, Rule S. Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial. Blood. 2021 Feb 18;137(7):877-887. doi: 10.1182/blood.2020008727.

location_country:
France
United Kingdom

location_facility: Derriford Hospital _ Plymouth Hospitals NHS Trust

summary:
This is an open label, multicenter, fixed dose and dose escalation, phase I/II study.

The study will be conducted in 3 steps. The first one (step A) will be to ensure the safety of the combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or refractory Mantle Cell Lymphoma (MCL).

A total of 9 patients have been included in the first step with grouped inclusions of three patients (safety evaluation performed at each inclusion of 3 patients).

No unacceptable toxicity has been observed during step A, thefore the second step (step B) was initiated. The aim of the second step was to determine the MTD of the GDC-0199 (400-600-800mg/d) in combination of GA101 and Ibrutinib (both respecting the previous doses) by using a Continual Reassessment Method. This dose escalation method was used until the 12th patient (3 patients included at 400mg/d of GDC-0199-(no DLT), 3 at 600mg/d- (no DLT) and 6 at 800mg/d, (not DLT reported so far). Once the last patient of the 800mg cohort is evaluated for DLT, all other patients will be treated at the dose of 400mg/d of GDC-0199.

The third step (step C) for untreated patients will be conducted at the dose of 400mg/d of GDC-0199. The aim of step C is to confirm the safety profile of the GA101 + Ibrutininb + GDC-199 combination according to step B result. 15 patients will be included in this step.


title: Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients

summary:
Haemophilia is a rare and serious congenital defect of blood coagulation due to a genetic mutation on a sexual chromosome. It affects quasi-essentially the men and it is responsible for bleeding. There are two types of haemophilia: Haemophilia A, (85 % of cases), due to a factor VIII (FVIII) deficiency and Haemophilia B (15 % of cases) due to factor IX (FIX) deficiency. According to the intensity of the defect, there are three forms of haemophilia: severe (FVIII or FIX lower than 1 %), moderate (factor level between 1 and 5 %), minor (factor level between 5 and 40 %). For a same level of factor VIII or IX, hemorrhagic manifestations are variable from one patient to the other. Moreover, several studies showed that haemophilic B patients bleed less and consume fewer anti-hemophilic concentrate that haemophilic A patients.

The main inhibitors of the coagulation are antithrombin, Protein C-Protein S-Thrombomodulin system, and tissue factor pathway inhibitor (TFPI). TFPI is the specific and exclusive inhibitor of tissue factor pathway that is the main way by which plasmatic coagulation starts. TFPI is a potent direct inhibitor of factor Xa and Xa-dependent inhibitor of the VIIa-Tissue Factor (TF) complex. In hemophilic patient, the production of Xa by the amplification pathway being strongly altered because of factor VIII or IX deficiency, thrombin generation (via Xa) comes exclusively from TFPI regulated tissue factor pathway. We can thus say that if haemophilic patients bleed, it is also because of the presence of TFPI that inhibits at the same time Xa and the complex TF-VIIa as soon as factor Xa is generated.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
HCL
CHU Saint-Etienne
Chu Nancy
Chu Reims
Chu Tours
AP-HM
CHRU Lille


title: OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS

lead_sponsor: Chiesi Farmaceutici S.p.A.

ReferenceType: result

ReferenceCitation: Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.

location_facility: Nephrology department CHU de Saint-Etienne Hospital Nord

location_facility: CHU Rangueil, 1 avenue J Poulhes TSA 50032.

location_facility: Nephrology Department Hopital La Cavale Blanche

location_facility: Unité de transplantation rénale -Hopital Pasteur

summary: Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.


title: Phase II Study of NAB-PACLITAXEL Plus FOLFOX as Perioperative Chemotherapy in Patients With Operable Oesogastric Adenocarcinoma

acronym: FOXAGAST

summary:
This is a non-randomized pauci-centre, open-label phase II study. The treatment will consist in a chemotherapy by FOLFOX and nab-paclitaxel following modalities determined in the Brown University Phase I study.

In neoadjuvant setting : 3 months of treatment

Main criteria of Withdraw of the treatment: in case of tumor progression, non acceptable toxicity, or patient decision.

Post-operative treatment (for 6 additional cycles) is recommended, but will depend on the result of the neo-adjuvant treatment and the ability of patients to receive adjuvant chemotherapy based on tolerance of neo-adjuvant treatment and general post-operative condition (i.e. adjuvant treatment if no progression during neo-adjuvant chemotherapy, less than 80% of residual viable tumor compared to initial tumor volume, acceptable tolerance and post-operative PS 0 - 2). Adjuvant treatment must be initiated within 8 weeks post-operatively.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

acronym: DSOPAL

summary:
Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

lead_sponsor: University Hospital, Limoges

location_facility:
Hospital
Joseph Ducuing hospital
University hospital


title: In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III

acronym: FIBRATLAS

summary:
White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.

Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.

location_facility:
University Hospital of Nancy
University Hospital of Brest
University Hospital of Angers
University Hospital of Amiens
University Hospital of Rennes
University Hospital of Tours
Hospital of Charpennes - Lyon


title: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

acronym: MACMAN

summary: The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

ReferenceCitation: Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.

ReferenceCitation: Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Tours
CHU Saint Louis
CHU Strasbourg Nouvel Hôpital Civil
CHU Paris Cochin
CHD Vendee
CHU Louis Mourier
CHU Orleans


title: Open-label, Multicenter, Dose-escalating Phase II Study to Investigate the Safety, Tolerability, and Early Signs of Efficacy of Subcutaneous Administrations of Tadekinig Alfa (IL-18BP) in Patients With Adult -Onset Still's Disease (AoSD) During 12 Weeks

summary:
The objective of this study is to assess safety, tolerability and early signs of efficacy of the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic auto-inflammatory disorder for which treatment remains empirical.

This disease is characterized by a daily spiking fever, arthralgia / arthritis, and skin rashes with frequent components of sore throat, lymphadenopathies and neutrophilic leukocytosis. The etiology is unknown. In addition to the above-mentioned clinical features, the diagnosis includes some laboratory components that reflect the systemic inflammation: high erythro-sedimentation rate, C-reactive protein, high serum ferritin and high levels of interleukin 18 (IL-18).

Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein (IL-18BP). This investigational drug was tested in healthy volunteers, psoriasis and rheumatoid arthritis patients in phase I studies. It demonstrated good safety and tolerability profile with only mild adverse events in the injection site.

ReferenceCitation: Bagnari V, Colina M, Ciancio G, Govoni M, Trotta F. Adult-onset Still's disease. Rheumatol Int. 2010 May;30(7):855-62. doi: 10.1007/s00296-009-1291-y. Epub 2009 Dec 18. Review.

ReferenceCitation: Bywaters EG. Still's disease in the adult. Ann Rheum Dis. 1971 Mar;30(2):121-33.

ReferenceCitation: Efthimiou P, Kontzias A, Ward CM, Ogden NS. Adult-onset Still's disease: can recent advances in our understanding of its pathogenesis lead to targeted therapy? Nat Clin Pract Rheumatol. 2007 Jun;3(6):328-35. Review.

ReferenceCitation: Fautrel B. Adult-onset Still disease. Best Pract Res Clin Rheumatol. 2008 Oct;22(5):773-92. doi: 10.1016/j.berh.2008.08.006. Review.

ReferenceCitation: Kawashima M, Yamamura M, Taniai M, Yamauchi H, Tanimoto T, Kurimoto M, Miyawaki S, Amano T, Takeuchi T, Makino H. Levels of interleukin-18 and its binding inhibitors in the blood circulation of patients with adult-onset Still's disease. Arthritis Rheum. 2001 Mar;44(3):550-60.

ReferenceCitation: Yamaguchi M, Ohta A, Tsunematsu T, Kasukawa R, Mizushima Y, Kashiwagi H, Kashiwazaki S, Tanimoto K, Matsumoto Y, Ota T, et al. Preliminary criteria for classification of adult Still's disease. J Rheumatol. 1992 Mar;19(3):424-30.

ReferenceCitation: Gabay C, Fautrel B, Rech J, Spertini F, Feist E, Kötter I, Hachulla E, Morel J, Schaeverbeke T, Hamidou MA, Martin T, Hellmich B, Lamprecht P, Schulze-Koops H, Courvoisier DS, Sleight A, Schiffrin EJ. Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease. Ann Rheum Dis. 2018 Jun;77(6):840-847. doi: 10.1136/annrheumdis-2017-212608. Epub 2018 Feb 22.

lead_sponsor: AB2 Bio Ltd.

location_country: Germany France Switzerland

location_facility: St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Rheumazentrum Ruhrgebiet

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin III Rheumatologie/Osteologie

location_facility: Medizinische Klinik - Rheumatologie und Klinische

location_facility: UNIVERSITÄTSMEDIZIN der Johannes-Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Rheumatologie

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Innere Medizin II - Rheumatologie Schlosspark-Klinik

location_facility: CHU Paris-GH La Pitié Salpêtrière-Charles Foix - Hôpital Pitié-Salpêtrière


title: Effect of Bosentan in Patients With Non Arteritic Ischemic Optic Neuropathy

acronym: ENDOTHELION

summary: Acute ischemic optic neuropathy are the second leading cause of optic neuropathy after glaucoma in the population aged over 50 years. The visual prognosis of the condition is unfavorable in the great majority of cases, with significant effects on the visual field and vision. The severity of the unilateral condition is also associated with bilateralization in 15% at 5 years. There is no effective treatment for the acute phase of the disease or to reduce the rate of bilateralization. In this context, it is essential to develop new therapeutic strategies in the acute phase of the disease to reduce the anatomical optic nerve damage.

ReferenceCitation: Chiquet C, Vignal C, Gohier P, Heron E, Thuret G, Rougier MB, Lehmann A, Flet L, Quesada JL, Roustit M, Milea D, Pepin JL; ENDOTHELION group. Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)-a multicentre randomised controlled trial protocol. Trials. 2022 Oct 29;23(1):916. doi: 10.1186/s13063-022-06786-9.

location_facility: Ophtalmological fondation of Rothschild + Bichat Hospital

location_facility: University Hospital of Grenoble Michallon


title: Phase 3 Prospective, Multicentric Randomized Study of Endoscopic Versus Surgical Treatment of Bile Duct Stricture in Chronic Pancreatitis

acronym: PASTEC

summary:
Biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. Morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures.

The PASTEC trial is a multicenter, phase III, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis.

The primary end point is 18-months normalization of serum alkaline phosphatase. Secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. Eighty-six patients need to be included.

lead_sponsor: University Hospital, Lille

location_facility:
Clinique de la Louvière
Centre Hospitalier Dr Schaffner
Centre hospitalier
Hôpital St Philibert


title: Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2

summary:
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.

Ninety-six patients and 9 centers are included in the protocol.

ReferenceCitation: Jmour O, Benna M, Champagnol P, Ben Mrad M, Hamrouni A, Obeid L, Lahmamssi C, Bousarsar A, Vial N, Rehailia-Blanchard A, Sotton S, Lan M, Langrand-Escure J, Vallard A, Magné N. CBCT evaluation of inter- and intra-fraction motions during prostate stereotactic body radiotherapy: a technical note. Radiat Oncol. 2020 Apr 19;15(1):85. doi: 10.1186/s13014-020-01534-2.

location_facility: Clinique Claude Bernard Service de radiothérapie CMCO Claude Bernard

location_facility: Site Hospitalier Nord Boulevard Jacques Monod


title: Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

acronym: PHYSICOSMICI

summary: This study is an observational study. The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD. Physical activity is an important determinant of health throughout the whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important health benefits. Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.

time_perspective: Cross-Sectional

location_facility:
Clinical Investigation Center
Centre Hospitalier
Centre hospitalier
Chu Amiens-Picardie - Site Sud
Centre Hospitalier St Vincent


title: A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia

ReferenceCitation: Fouquet G, Guidez S, Petillon MO, Louni C, Ohyba B, Dib M, Poulain S, Herbaux C, Martin A, Thielemans B, Brice P, Choquet S, Bakala J, Bories C, Demarquette H, Nudel M, Tournilhac O, Arnulf B, LeGouill S, Morel P, Banos A, Karlin L, Salles G, Leblond V, Leleu X. Lenalidomide is safe and active in Waldenström macroglobulinemia. Am J Hematol. 2015 Nov;90(11):1055-9. doi: 10.1002/ajh.24175. Epub 2015 Oct 6.

location_facility:
Ch Nantes
Centre Hospitalier de la côte basque
Ch Clermond Ferrand
CH LENS
Chru Lille
Centre Hospitalier Lyon Sud
Groupe hospitalier Pitié Salpétrière

summary: The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.


title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

acronym: PRISM

summary:
Primary objective:

To assess the efficacy of I10E in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Spain
Italy
United Kingdom
Tunisia
Turkey
France

location_facility: Marmara Universitesi Egitim Ve Arastirma Hastanesi

location_facility: Azienda Ospedaliere Universitaria san Giovanni

location_facility: IRRCS Istituto Nazionale Neurologico Besta

location_facility: Hacettepe University Medical School Neurology

location_facility: Ankara University medical School Neurology

location_facility: Uludag University Medical School Neurology

location_facility: Hospital clinico Universitario de Santiago

location_facility: Istanbul UniversityCerrahpasa Medical School Neurology

location_facility: University Hospital of North Straffordshire

location_facility: Hospital Universitario i Politècnico La Fe

location_facility: Azienda Ospedaliere Universitaria di Padova


title: Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

acronym: IDASPHERE II

summary:
The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and epirubicin (12%). But until recently, there were no obvious reasons to use one product over another. In fact, systemic chemotherapy is considered ineffective in HCC [hepatocellular carcinoma], which does not allow any argument in favour of the product. Moreover, 2 randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative in terms of survival.

Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was noted especially on the SNU-449 line, which is known for its resistance to several chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1) idarubicin has a better intracellular penetration than the other anthracyclines. This is probably due to its more considerable lipophily, facilitating thus its passage through the membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane pumps transporting the molecule outside the cell. These two particularities could explain a more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its toxicity profile (especially, haematological and cardiac) is known.

On these grounds, A pilot study has been conducted in order to assess the tolerance and efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and less toxic.

Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The DLT [dose-limiting toxicity] and MTD [maximum tolerated dose] have been determined in 21 patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m². There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) = approx. 10 mg of idarubicin.

It has been already demonstrated that hepatic extraction of idarubicin is better than those of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC 0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was 35% higher.

The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised trial on CHE published. The PRECISION V data can be thus used to compare the other studies in terms of efficacy and tolerance.

To continue our preliminary study and the phase I IDASPHERE study, investigators wish to assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.

ReferenceCitation: Guiu B, Chevallier P, Assenat E, Barbier E, Merle P, Bouvier A, Dumortier J, Nguyen-Khac E, Gugenheim J, Rode A, Oberti F, Valette PJ, Yzet T, Chevallier O, Barbare JC, Latournerie M, Boulin M. Idarubicin-loaded Beads for Chemoembolization of Hepatocellular Carcinoma: The IDASPHERE II Single-Arm Phase II Trial. Radiology. 2019 Jun;291(3):801-808. doi: 10.1148/radiol.2019182399. Epub 2019 Apr 30.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
CHU - Hôpital François Mitterand
CHU St Eloi
Hôpital Edouard Herriot
CHU d'ANGERS
Hôpital La Croix Rousse
Hôpital de l'Archet II
CHU Amiens


title: Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

acronym: Radiointer

summary:
The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.

Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,

This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :

Arm A: Percutaneous vertebroplasty
Arm B: External radiotherapy

This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

location_facility:
Institut Bergonié
Centre Paul Strauss
Centre Antoine Lacassagne
Institut Gustave Roussy
Centre Leon Berard
Institut Curie
HCL- Hopital Edouard Herriot


title: A Prospective, Multicenter and Observational Trial to Evaluate Evolution of Quality of Life (SF-36) After Total Thyroidectomy.

acronym: ThyrQol

summary: The purpose of this study is to evaluate the evolution of quality of life and voice function with different questionnaires (VIH, SF36) before and after total thyroidectomy.

location_facility:
La Pitié-Salpétrière - AP-HP
Limoges University Hospital
CHD La Roche sur Yon
Lyon University Hospital
Angers University Hospital
Nancy University Hospital
Nantes University Hospital


title: IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes

acronym: IMAGE

summary: Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.

primary_purpose: Screening

location_facility: Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition

location_facility: Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie

location_facility: CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition

location_facility: Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8

location_facility: CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition


title: Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease

acronym: VICCOINBODI

summary:
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.

This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.

If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.

Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.

location_facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP

location_facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP

location_facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux

location_facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

location_facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille

location_facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes


title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

acronym: RINO

summary: The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

ReferenceCitation: Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

ReferenceCitation: Chaudhuri D, Granton D, Wang DX, Einav S, Helviz Y, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson C, Jaber S, Brochard L, Burns KEA, Rochwerg B. Moderate Certainty Evidence Suggests the Use of High-Flow Nasal Cannula Does Not Decrease Hypoxia When Compared With Conventional Oxygen Therapy in the Peri-Intubation Period: Results of a Systematic Review and Meta-Analysis. Crit Care Med. 2020 Apr;48(4):571-578. doi: 10.1097/CCM.0000000000004217.

lead_sponsor: Catholic University of the Sacred Heart

location_country: France Italy Spain Greece

location_facility: Università del Piemonte Orientale, Sant'Andrea Hospital

location_facility: La Pitie-Salpetriere University Hospital

location_facility: Università del Piemonte Orientale, Ospedale della Carità

location_facility: Catholic University of the Sacred Heart, A. Gemelli Hospital


title: A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.

acronym: RACE

summary: The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

ReferenceCitation: Peffault de Latour R, Kulasekararaj A, Iacobelli S, Terwel SR, Cook R, Griffin M, Halkes CJM, Recher C, Barraco F, Forcade E, Vallejo JC, Drexler B, Mear JB, Smith AE, Angelucci E, Raymakers RAP, de Groot MR, Daguindau E, Nur E, Barcellini W, Russell NH, Terriou L, Iori AP, La Rocca U, Sureda A, Sánchez-Ortega I, Xicoy B, Jarque I, Cavenagh J, Sicre de Fontbrune F, Marotta S, Munir T, Tjon JML, Tavitian S, Praire A, Clement L, Rabian F, Marano L, Hill A, Palmisani E, Muus P, Cacace F, Frieri C, van Lint MT, Passweg JR, Marsh JCW, Socié G, Mufti GJ, Dufour C, Risitano AM; Severe Aplastic Anemia Working Party of the European Society for Blood and Marrow Transplantation. Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia. N Engl J Med. 2022 Jan 6;386(1):11-23. doi: 10.1056/NEJMoa2109965.

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Netherlands

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: Hospital Universitari Germans Trias I Pujol


title: Medico-economic Evaluation of the Management of Weight Regain After Gastric Bypass by Gastrointestinal Narrowing of Jejunal Anastomosis by Endoscopic Suturing: Apollo Endosurgery OverStitch Technical

summary: Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment

lead_sponsor: University Hospital, Montpellier

location_facility:
Villeurbanne clinic
Nice Hospital
Strasbourg Hospital
Louis Mourier Hospital
HEGP Hospital
Lille Hospital
Montpellier Hospital

intervention_type: Diagnostic Test


title: Frequency of Diagnostic Symptomatic Pulmonary Embolism's in Patients Hospitalized for Clinical Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

acronym: PEP

summary: A standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised Geneva score), plasma D-dimer assay and if necessary, a multidetector-row CT angiography thoracic and venous ultrasound of the lower limbs. All the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.

lead_sponsor: University Hospital, Brest

location_facility:
HIA
CHU Clermont-Ferrand
CH de Cornouaille Quimper
Hôpital Nord
Hôpital Européen Georges Pompidou
CHU
CHRU de Brest


type: Other Grant/Funding Number

title: Impact of Music Therapy on Prescription of Neuroleptics in Alzheimer's Disease ou Related Symptoms Associated With Disruptive Behaviours.

acronym: PRE-MUSICAL

summary:
The primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with AD or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the Neuropsychiatric Inventory (NPI).

The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

ReferenceCitation: Aalten P, de Vugt ME, Jaspers N, Jolles J, Verhey FR. The course of neuropsychiatric symptoms in dementia. Part I: findings from the two-year longitudinal Maasbed study. Int J Geriatr Psychiatry. 2005 Jun;20(6):523-30.

ReferenceCitation: Aldridge D. Music and Alzheimer's disease--assessment and therapy: discussion paper. J R Soc Med. 1993 Feb;86(2):93-5.

ReferenceCitation: Benoit M, Robert PH, Staccini P, Brocker P, Guerin O, Lechowski L, Vellas B; REAL.FR Group. One-year longitudinal evaluation of neuropsychiatric symptoms in Alzheimer's disease. The REAL.FR Study. J Nutr Health Aging. 2005;9(2):95-9.

ReferenceCitation: Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84.

lead_sponsor: University Hospital, Toulouse

location_facility:
EHPAD Les Quietudes
Centre Hospitalier Gérard Marchant
University Hospital Toulouse
EHPAD L'Oustal d'en Thibaud
Residence Christian Bressole
EHPAD La Villegiale
EHPAD KORIAN Grand Maison

intervention_type: Behavioral


title: A European Multicentre Double-blind Placebo-controlled Phase III Trial of Nilvadipine in Mild to Moderate Alzheimer's Disease

acronym: NILVAD

summary:
Alzheimer's disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).

Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.

ReferenceCitation: Brogden RN, McTavish D. Nilvadipine. A review of its pharmacodynamic and pharmacokinetic properties, therapeutic use in hypertension and potential in cerebrovascular disease and angina. Drugs Aging. 1995 Feb;6(2):150-71. Review. Erratum in: Drugs Aging 1995 Aug;7(2):116.

ReferenceCitation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83.

ReferenceCitation: Facchinetti F, Fasolato C, Del Giudice E, Burgo A, Furegato S, Fusco M, Basso E, Seraglia R, D'Arrigo A, Leon A. Nimodipine selectively stimulates beta-amyloid 1-42 secretion by a mechanism independent of calcium influx blockage. Neurobiol Aging. 2006 Feb;27(2):218-27.

ReferenceCitation: Fleckenstein A. Specific pharmacology of calcium in myocardium, cardiac pacemakers, and vascular smooth muscle. Annu Rev Pharmacol Toxicol. 1977;17:149-66. Review.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Birkenhäger WH, Babarskiene MR, Babeanu S, Bossini A, Gil-Extremera B, Girerd X, Laks T, Lilov E, Moisseyev V, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Fagard R. Prevention of dementia in randomised double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial. Lancet. 1998 Oct 24;352(9137):1347-51.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Babarskiene MR, Babeanu S, Bossini A, Fagard R, Gil-Extremera B, Laks T, Kobalava Z, Sarti C, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Birkenhäger WH; Systolic Hypertension in Europe Investigators. The prevention of dementia with antihypertensive treatment: new evidence from the Systolic Hypertension in Europe (Syst-Eur) study. Arch Intern Med. 2002 Oct 14;162(18):2046-52. Erratum in: Arch Intern Med. 2003 Jan 27;163(2):241..

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Furuichi Y, Takakura S, Satoh H, Mori J, Kohsaka M. The effect of nilvadipine, a dihydropyridine type calcium channel blocker, on local cerebral blood flow in rats. Jpn J Pharmacol. 1992 Apr;58(4):457-60.

ReferenceCitation: Gélinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81.

ReferenceCitation: Hanyu H, Hirao K, Shimizu S, Sato T, Kiuchi A, Iwamoto T. Nilvadipine prevents cognitive decline of patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2007 Dec;22(12):1264-6.

ReferenceCitation: Inouye M, Mio T, Sumino K. Nilvadipine protects low-density lipoprotein cholesterol from in vivo oxidation in hypertensive patients with risk factors for atherosclerosis. Eur J Clin Pharmacol. 2000 Apr;56(1):35-41.

ReferenceCitation: Khachaturian AS, Zandi PP, Lyketsos CG, Hayden KM, Skoog I, Norton MC, Tschanz JT, Mayer LS, Welsh-Bohmer KA, Breitner JC. Antihypertensive medication use and incident Alzheimer disease: the Cache County Study. Arch Neurol. 2006 May;63(5):686-92. Epub 2006 Mar 13.

ReferenceCitation: Kagawa H, Nomura S, Ozaki Y, Nagahama M, Fukuhara S. Effects of nilvadipine on cytokine-levels and soluble factors in collagen disease complicated with essential hypertension. Clin Exp Hypertens. 1999 Oct;21(7):1177-88.

ReferenceCitation: López-Arrieta JM, Birks J. Nimodipine for primary degenerative, mixed and vascular dementia. Cochrane Database Syst Rev. 2002;(3):CD000147. Review.

ReferenceCitation: Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13.

ReferenceCitation: Maxwell CJ, Hogan DB, Ebly EM. Calcium-channel blockers and cognitive function in elderly people: results from the Canadian Study of Health and Aging. CMAJ. 1999 Sep 7;161(5):501-6. Erratum in: CMAJ 1999 Nov 30;161(11):1396.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44.

ReferenceCitation: Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983;19(3):448-50.

ReferenceCitation: Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50.

ReferenceCitation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4.

ReferenceCitation: Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65.

ReferenceCitation: Ogasawara K, Noda A, Yasuda S, Kobayashi M, Yukawa H, Ogawa A. Effect of calcium antagonist on cerebral blood flow and oxygen metabolism in patients with hypertension and chronic major cerebral artery occlusion: a positron emission tomography study. Nucl Med Commun. 2003 Jan;24(1):71-6.

ReferenceCitation: Ohtsuka M, Ono T, Hiroi J, Esumi K, Kikuchi H, Kumada S. Comparison of the cardiovascular effect of FR34235, a new dihydropyridine, with other calcium antagonists. J Cardiovasc Pharmacol. 1983 Nov-Dec;5(6):1074-82.

ReferenceCitation: Parry SW, Steen N, Baptist M, Fiaschi KA, Parry O, Kenny RA. Cerebral autoregulation is impaired in cardioinhibitory carotid sinus syndrome. Heart. 2006 Jun;92(6):792-7. Epub 2006 Jan 31.

ReferenceCitation: Rosenthal J. Nilvadipine: profile of a new calcium antagonist. An overview. J Cardiovasc Pharmacol. 1994;24 Suppl 2:S92-107. Review.

ReferenceCitation: Shimamoto H, Shimamoto Y. Nilvadipine increases cerebral blood flow in elderly hypertensives: comparison with nifedipine. J Hum Hypertens. 1995 Apr;9(4):271-9.

ReferenceCitation: Tollefson GD. Short-term effects of the calcium channel blocker nimodipine (Bay-e-9736) in the management of primary degenerative dementia. Biol Psychiatry. 1990 May 15;27(10):1133-42.

ReferenceCitation: Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16.

ReferenceCitation: Yasar S, Corrada M, Brookmeyer R, Kawas C. Calcium channel blockers and risk of AD: the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 2005 Feb;26(2):157-63.

ReferenceCitation: Dyer AH, Lawlor B, Kennelly SP; NILVAD Study Group. Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD. BMC Geriatr. 2020 Mar 30;20(1):117. doi: 10.1186/s12877-020-01531-w.

ReferenceCitation: Abdullah L, Crawford F, Tsolaki M, Börjesson-Hanson A, Olde Rikkert M, Pasquier F, Wallin A, Kennelly S, Ait-Ghezala G, Paris D, Hendrix S, Blennow K, Lawlor B, Mullan M. The Influence of Baseline Alzheimer's Disease Severity on Cognitive Decline and CSF Biomarkers in the NILVAD Trial. Front Neurol. 2020 Mar 6;11:149. doi: 10.3389/fneur.2020.00149. eCollection 2020.

ReferenceCitation: de Heus RAA, Olde Rikkert MGM, Tully PJ, Lawlor BA, Claassen JAHR; NILVAD Study Group. Blood Pressure Variability and Progression of Clinical Alzheimer Disease. Hypertension. 2019 Nov;74(5):1172-1180. doi: 10.1161/HYPERTENSIONAHA.119.13664. Epub 2019 Sep 23.

ReferenceCitation: de Jong DLK, de Heus RAA, Rijpma A, Donders R, Olde Rikkert MGM, Günther M, Lawlor BA, van Osch MJP, Claassen JAHR. Effects of Nilvadipine on Cerebral Blood Flow in Patients With Alzheimer Disease. Hypertension. 2019 Aug;74(2):413-420. doi: 10.1161/HYPERTENSIONAHA.119.12892. Epub 2019 Jun 17.

ReferenceCitation: de Heus RAA, Donders R, Santoso AMM, Olde Rikkert MGM, Lawlor BA, Claassen JAHR; Nilvad Study Group. Blood Pressure Lowering With Nilvadipine in Patients With Mild-to-Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension. J Am Heart Assoc. 2019 May 21;8(10):e011938. doi: 10.1161/JAHA.119.011938.

ReferenceCitation: Lawlor B, Segurado R, Kennelly S, Olde Rikkert MGM, Howard R, Pasquier F, Börjesson-Hanson A, Tsolaki M, Lucca U, Molloy DW, Coen R, Riepe MW, Kálmán J, Kenny RA, Cregg F, O'Dwyer S, Walsh C, Adams J, Banzi R, Breuilh L, Daly L, Hendrix S, Aisen P, Gaynor S, Sheikhi A, Taekema DG, Verhey FR, Nemni R, Nobili F, Franceschi M, Frisoni G, Zanetti O, Konsta A, Anastasios O, Nenopoulou S, Tsolaki-Tagaraki F, Pakaski M, Dereeper O, de la Sayette V, Sénéchal O, Lavenu I, Devendeville A, Calais G, Crawford F, Mullan M; NILVAD Study Group. Nilvadipine in mild to moderate Alzheimer disease: A randomised controlled trial. PLoS Med. 2018 Sep 24;15(9):e1002660. doi: 10.1371/journal.pmed.1002660. eCollection 2018 Sep.

lead_sponsor: Prof Brian Lawlor

location_country:
United Kingdom
Ireland
Greece
Italy
Netherlands
Sweden
Hungary
France
Germany

location_facility: Centre Hospitalier Regional et Universitaire de Lille (CHRU Lille)

location_facility: Centre Hospitalier Universitaire de Bethune (CH Bethune)

location_facility: Centre Hospitalier Universitaire de Saint Philibert (GHICL)

location_facility: Centre Hospitalier Universitaire de Lens (CHU Lens)

location_facility: Centre Hospitalier Universitaire de Calais (CHU Calais)

location_facility: Centre Hospitalier Universitaire de Caen (CHU Caen)

location_facility: Centre Hospitalier Universitaire d'Amiens (CHU Amiens)


acronym: NeuroSenSS

summary:
Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. Fifteen to twenty percent of patients with the primary Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (SFN). A recent study proved that more than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.

The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. Moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy.

Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.

location_facility:
CHU Bordeaux
CHU Toulouse
University Hospital, Limoges
CH d'Albi
CHU de Lille
CH de Brive
CH de Rodez


title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care

acronym: Bakri

summary:
This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.

ReferenceCitation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7:CD013663. doi: 10.1002/14651858.CD013663.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.

acronym: STRADA

summary:
The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.

Patients and Methods:

Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).

Expected results:

On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Lille
Elbeuf Hospital
UH Caen
Le Havre Hospital
UH Amiens
UH Rouen
Dieppe Hospital


type: Registry Identifier

title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.

acronym: MispheC

summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.

lead_sponsor: Center Eugene Marquis

location_facility:
CHU- Hotel Dieu
CHU Poitiers
Hôpital saint-Eloi
Centre Eugene Marquis
CHU Nancy - Hôpital Brabois
Hôpital Henri Mondor
Hôpital Beaujon - Service de Chirurgie