title: Creation of a Register of Patients With Neonatal-onset Epileptic Encephalopathy

acronym: IMPROVE

summary:
Electrical activity emerges in the third trimester of pregnancy, plays an important role in the construction of cortical maps, and is impaired in patients with severe early epileptic encephalopathies (EOEE). EOEE are rare and severe epileptic syndromes characterized by epilepsy that begins within the first three months of life and is associated with rapid deterioration of motor, cognitive and behavioral skills.

There is a genetic basis for the EOEE. Together with other laboratories, the investigators have identified de novo pathogenic variants in the KCNQ2 gene encoding the Kv7.2 subunit of the Kv7 / M potassium channel, a channel known to control neuronal excitability in the brain and spinal cord. via the current M (IM). Pathogenic variants of the KCNQ2 gene represent the main cause of EOEE and the term KCNQ2-related epileptic encephalopathy (KCNQ2-REE) is now used to define this condition.

KCNQ2-REE patients have a remarkably homogeneous phenotype at the start, with epilepsy that begins in the first days after birth, seizures that result in tonic muscle spasms that last from 1 to 10 seconds, and an interictal EEG called "suppression-burst". "That is, paroxysmal bursts of activity interspersed with periods of electrical silence. In this group, more than 50% of the patients present a remission of the epilepsy and a quasi-normalization of the EEG which can occur a few weeks to several months after the onset of the seizures. Despite this positive evolution in terms of seizures, the developmental progression is abnormal and the phenotype is severe with an absence of language, autistic behavior and a subsequent development of motor disorders such as diplegia, spasticity, ataxia or dystonia.

The ambition of this project is to increase knowledge of epileptic encephalopathies linked to KCNQ2 at the clinical and molecular levels, to decipher the pathophysiological mechanisms and to propose therapeutic strategies.

This project aims to better describe the clinical, EEG, imaging, developmental and long-term follow-up characteristics of patients carrying the KCNQ2 mutation identified in the laboratory.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHU Angers
CHRU Lille
Hôpital Necker
CHU Limoges
CHU Toulouse
Hôpital La Timone
APHP Pitié Salpêtrière
CHRU Strasbourg
CHU Bordeaux
CHU Montpellier
APHP Robert Debré
CHU Tours
CHU Rennes
CHU Brest
Hospices Civils Lyon


title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial

acronym: LapCHC

summary:
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.

Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Chirurgie Digestive et Transplantations - Hôpital Huriez

location_facility: Chirurgie viscérale et digestive - CHU Caean

location_facility: Chirurgie hépato-biliaire et greffe de foie - La Pitié

location_facility: Chirurgie digestive - Institut Mutualiste Montsouris

location_facility: Chirurgie viscérale et digestive - CHU Rouen

location_facility: Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse

location_facility: Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse

location_facility: Chirurgie Diestive et de l'Urgence - CHU Grenoble

location_facility: Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor

location_facility: Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours

location_facility: Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer

summary:
SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy.

The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who do not present a progressive disease after 6-8 cycles of chemotherapy.

status: Active, not recruiting

lead_sponsor: UNICANCER

location_facility: CInstitut Regional du cancer-Centre Val D'Aurelle

location_facility: Institut de Cancérologie de l'Ouest/Paul Papin

intervention_type: Drug

lead_sponsor_type: industriel


title: Retrospective Multicenter Study of Paclitaxel in Combination With Bevacizumab in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC).

acronym: AVATAX

summary: The aim of the study is to evaluate the paclitaxel-bevacizumab combination retrospectively and multicenter in current practice, with subgroup analyses of the following patients: patients who have previously received immunotherapy, patients with an EGFR or ALK oncogenic addiction pathway, patients who have previously received taxanes or anti-angiogenic agents.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Institut de Cancérologie Lucien Neuwirth

status_simplified: Completed


type: Other Identifier

title: PROtein S100B for Mild Trauma of the HEad in Emergency Patients

acronym: PROMETHEE

summary:
Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging.

The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven.

Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category.

Victims of brain injury that do not fall into this category are considered less critical.

By definition, mild traumatic brain injury :

a trauma of the cephalic extremity :
whose Glasgow score (30 min after the trauma or during the consultation) is 13-15,
associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion).

Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics :

a retrograde amnesia of more than 30 minutes,

a loss of consciousness or amnesia associated with:

either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter),
or an age> 65 years,
or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging.

Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain.

In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery.

Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging.

The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Princesse Grace

location_country: Monaco France

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Carémeau

location_facility: AP-HP Centre Hospitalier Universitaire Henri-Mondor

location_facility: Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

intervention_type: Other


title: Assessment of the Diagnostic Approach to Specific Language Disorders and Learning Using a New Calibrated Tool: the Modular Battery Tests Computerized (BMTi)

acronym: ValidBMTI

summary:
The group of experts at HAS has defined the places of first and second-line workers in specific disorders of development and learning, as defined in the international diagnostic classifications International Classification of Diseases (CIM) CIM 11 and Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM 5. The referral to a second-level structure, a multidisciplinary structure in charge of carrying out the different cognitive assessments, requires a preliminary evaluation.

This orientation is based on a medical consultation, carried out by a doctor specialized in the field, with an exploration tool adapted to the different fields concerned.

The BMTi, a battery of third-generation tests (after the Rapid battery of evaluation of the cognitive functions (BREV) and then the Evaluation of cognitive functions and learning of the child (EDA)) will enable the doctor, from 2018, to carry out this orientation in a relevant way in response to children with a complaint about neurodevelopment and learning. .

The research project aims to validate this hypothesis, by comparing the diagnoses posed in a conventional way with the various multidisciplinary assessments, with the results of the transfer of all or part of the subtests of the BMTi by a doctor of second resort.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_country: Martinique France

location_facility:
Cabinet du Dr Dulorme
Cabinet du Dr Werner
Cabinet du Dr Vurpillat-Almanza
Cabinet du Dr Gelbert
CHU de Rouen
Centre Médical Pédiatrique Flammarion
Cabinet du Dr Reynaud
Cabinet du Dr Kochert
Centre Paris Santé Réussite
Cabinet du Dr Willig
Cabinet du Dr Lubelski
CH Versailles - André Mignot
Cabinet du Dr Cahn-Sellem
Hôpital Saint Eloi - Montpellier
Cabinet du Dr Pineau
Cabinet du Dr Piollet

intervention_type: Behavioral


title: Effects of a Serious Game Based Exercise Program on the Functional Autonomy in Older Adults Living in Nursing Homes : SERIOUS AUTONOMY

summary: Assessment of the effect of a 12 weeks serious game based exercises program on physical performance in older adults living in nursing homes, in comparison with a control group that benefits from a classical exercise training program including balance, muscle strengthening and walking exercises with the same duration.

status: Suspended

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier

location_facility: EHPAD Résidence Château Notre Dame (Groupe Orpéa)

location_facility: EHPAD Françoise Gauffier CCAS de Montpellier

location_facility: EHPAD Résidence La Camargue, Nimes (Groue Orpéa)

location_facility: EHPAD Pierre Laroque CCAS de Montpellier

status_simplified: Unknown


title: Multifaceted Intervention for Increasing Performance of Cardiopulmonary Resuscitation by Laypersons in Out-of-hospital Cardiac Arrest. A Stepped Wedge Cluster Randomized Controlled Trial

acronym: DISPATCH

summary:
Cardiac arrest (CA) early recognition is essential in order to rapidly activate emergency services and for bystanders to begin cardiopulmonary resuscitation (CPR).

As soon as a call is received, EMS dispatchers should try to identify CA. This may be difficult, in a context of stress and distress of the person calling. Yet, it is vital for bystanders to initiate CPR. Survival can be multiplied by 2 to 4 if the bystanders initiate a CPR before the arrival of the emergency medical services.

This work aim to assess a multifaceted intervention combining 3 elements to improve the initial phone recognition of CA and raise the number of patients benefiting from CPR before EMS arrival on scene.

The first element is a dispatcher training to the early phone recognition of CA. This training will be based on the concept of active teaching, favouring the interactive work of learners in particular by listening to real dispatch recordings. It will be completed by continuing education with a distance teaching platform including the systematic listening of recorded CA calls.

The second element is based on the deployment of a software aiming to notify CA thanks to mobile phones. This system interfaced to a control software enables to request the participation of CPR-trained volunteers automatically. The volunteers have to be located in the patient's surroundings. The deployment of this mobile application will rely on first-aid volunteers, health personal and any trained volunteers willing to participate. A randomized control study in one city area proved the efficiency of a similar software to improve the proportion of CPR by bystanders.

The third element consists in a motivational feedback. A weekly overview of the management and the outcomes of patients who suffered CA will be broadcast to all the responders and volunteers in the mobile application.

ipd_sharing: Yes

ipd_sharing_description: Study protocol will be submitted for publication. IPD will be shared with other researcher.

lead_sponsor: University Hospital, Grenoble

location_facility: SAMU 73 - Centre Hospitalier Métropôle Savoie


title: Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

summary:
The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).

at diagnosis
after the first cycle of CHOEP (early evaluation)
at the end of treatment

ReferenceType: background

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ReferenceCitation: Damm-Welk C, Pillon M, Woessmann W, Mussolin L. Prognostic factors in paediatric anaplastic large cell lymphoma: role of ALK. Front Biosci (Schol Ed). 2015 Jun 1;7:205-16. Review.

ReferenceCitation: Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugières L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy

summary: Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Institut Paoli-Calmettes - Hématologie 2

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie


title: Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

acronym: CHARLIE

summary: To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

primary_purpose: Other

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ReferenceCitation: Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.

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ReferenceCitation: Infante DD, Segarra OO, Redecillas SS, Alvarez MM, Miserachs MM. Modification of stool's water content in constipated infants: management with an adapted infant formula. Nutr J. 2011 May 19;10:55. doi: 10.1186/1475-2891-10-55.

ReferenceCitation: Kunz C, Lönnerdal B. Human-milk proteins: analysis of casein and casein subunits by anion-exchange chromatography, gel electrophoresis, and specific staining methods. Am J Clin Nutr. 1990 Jan;51(1):37-46.

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ReferenceCitation: Long T, Johnson M. Living and coping with excessive infantile crying. J Adv Nurs. 2001 Apr;34(2):155-62.

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ReferenceCitation: Mitchell DJ, McClure BG, Tubman TR. Simultaneous monitoring of gastric and oesophageal pH reveals limitations of conventional oesophageal pH monitoring in milk fed infants. Arch Dis Child. 2001 Mar;84(3):273-6.

ReferenceCitation: Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105.

ReferenceCitation: Polack FP, Khan N, Maisels MJ. Changing partners: the dance of infant formula changes. Clin Pediatr (Phila). 1999 Dec;38(12):703-8.

ReferenceCitation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17.

ReferenceCitation: Recio I, Pérez-Rodríguez ML, Amigo L, Ramos M. Study of the polymorphism of caprine milk caseins by capillary electrophoresis. J Dairy Res. 1997 Nov;64(4):515-23.

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location_facility:
169 Avenue Achille Peretti
157 Avenue du Général Leclerc
CHU Robert Debré, 48 Bd Sérurier
4 Rue Edouard Quenu
20 avenue du général Sarail
67 Rue Condorcet,
65 Avenue Henri Barbusse,
62 avenue Jean Jaures
67 Rue Condorcet
53 Boulevard De La Liberté
2 Avenue Camille Blanc,
3 Allée du 8 Mai 1945,
41 Rue Aristide Briand,
13 Villa Beauséjour
92 Avenue de la République


title: Adapted Physical Activity in Patients With Resected Pancreatic Cancer (APACaPOp PRODIGE-56 Study): a National Multicenter Randomized Controlled Phase II Trial

acronym: APACaPOp

summary:
Exercise during chemotherapy (CT) is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). Exercise may also have beneficial effects on tumor outcome by decreasing insulin resistance, inflammation, and by modulating various pro-tumoral signalling pathways. It has been shown to reduce mortality in breast and colorectal cancer adjuvant setting.

This study aims to explore the effects of adapted physical activity (APA) in patients with resected pancreatic ductal adenocarcinoma (PDAC).

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Edouard Herriot
Hôpital Henri Mondor
Hôpital Haut-Lévêque
Institut Mutualiste Montsouris
CHU de Reims
CHR d'Orléans
CHU de Rouen
Centre Paul Strauss
Hôpital Cochin
Institut Curie
CHU de Brest
CHU de Toulouse
CHU de Besançon
Hôpital privé Jean Mermoz
Hôpital Beaujon


title: RObotic PArtial Nephrectomy National Study (RoPaN Study)

acronym: ROPAN

summary: The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU La Pitié Salpétrière/ Kremlin Bicêtre


title: Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy

summary:
Increasing cases of women with dilated cardiomyopathy with a project of pregnancy are observed. However there is few knowledge and publications about cardiac diseases in pregnant women. Moreover the majority of medical articles deal with women with congenital heart diseases, valvular pathologies or peripartum cardiomyopathies, and few data are available in literature about women with dilated cardiomyopathy diagnosed before or during the first months of the pregnancy.

Cardiologist and obstetrician advices are considerably limited when patients with dilated cardiomyopathy have a pregnancy project. Knowledges and know-how are currently based on limited personal experiment or on few clinical cases descriptions.

Pregnancy represents a high-risk situation for patients with dilated cardiomyopathy. Creation of a cohort of pregnant women with dilated cardiomyopathy collecting specific data will allow to have a better overview and to appreciate possibilities of a pregnancy project, evolution risks and modalities for medical attention and to improve follow-up and advices delivered to these patients.

lead_sponsor: Nantes University Hospital

location_facility:
Hospital Henri Mondor
AP-HM
CHU de NANTES
Chu Nancy
Hegp Pompidou
Chu Angers
Ap-Hp Bichat
Chu Rennes
Chru de Brest
Chu Rouen
CHU NICE
Chu Toulouse
Hospital Lariboisière
Chru Lille
Hospital Salpetrière


title: Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

acronym: VISIOCYT 1

summary: This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

primary_purpose: Diagnostic

lead_sponsor: Vitadx

location_facility:
Hôpital Edouard Herriot
Clinique " la Châtaigneraie "
CHU Caremeau, Nimes
Hôpital d'Antony
Institut Paoli-Calmettes
CHRU Nancy
CHU de Clermont-Ferrand
Hôpital Cochin
Hopital Rangueil
Hôtel Dieu, CHR de Nantes
Clinique BeauSoleil
Hôpital Foch
CHU Rennes
CHU de Besançon


title: Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q: a Multicenter, Randomized, Double-blind, Placebo Controlled Study - QOL-ONE Rev2MDS

summary:
Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in the presence of bleeding.

In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has been approved by FDA and EMA. It has been shown that the drug induces significant erythroid (about 65%) and cytogenetic responses which have been associated with a survival benefit. In patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of transfusion-independence and cytogenetic responses with a trend to survival advantage. As a consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days 1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.

For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥ 25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at any time, to resume lenalidomide at 50% dose reduction.

Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.

Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy, safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown that eltrombopag is able to significantly raise PLT counts in about 65% of patients without additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in significant inhibitory effects on the growth of leukemic colonies in the majority of primary MDS and AML samples. Most importantly, eltrombopag was able to reverse the anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results provide a preclinical rationale for the use of this combination in MDS and AML

status: Terminated

ipd_sharing: Undecided

lead_sponsor: Associazione Qol-one

location_country: Italy France Greece

location_facility: U.O. Citta' della Salute e della Scienza di Torino

location_facility: "G.Gennimatas" General Hospital of Athens

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: A.O. Citta' della Salute e della Scienza di Torino

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: "George Papanicolaou General Hospital of Thessaloniki


title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial

summary:
A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.

ReferenceType: derived

ReferenceCitation: Diguisto C, Le Gouge A, Arthuis C, Winer N, Parant O, Poncelet C, Chauleur C, Hannigsberg J, Ducarme G, Gallot D, Gabriel R, Desbriere R, Beucher G, Faraguet C, Isly H, Rozenberg P, Giraudeau B, Perrotin F; Groupe de Recherche en Obstétrique et Gynécologie (GROG). Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021 Feb 11;18(2):e1003448. doi: 10.1371/journal.pmed.1003448. eCollection 2021 Feb.

family: Diguisto

full_name: Caroline Diguisto

given: Caroline

sequence: first

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

sequence: additional

family: Arthuis

full_name: Chloé Arthuis

given: Chloé

family: Winer

full_name: Norbert Winer

given: Norbert

family: Parant

full_name: Olivier Parant

given: Olivier

family: Poncelet

full_name: Christophe Poncelet

given: Christophe

family: Chauleur

full_name: Celine Chauleur

given: Celine

family: Hannigsberg

full_name: Jacob Hannigsberg

given: Jacob

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

family: Gallot

full_name: Denis Gallot

given: Denis

family: Gabriel

full_name: Rene Gabriel

given: Rene

family: Desbriere

full_name: Raoul Desbriere

given: Raoul

family: Beucher

full_name: Gael Beucher

given: Gael

family: Faraguet

full_name: Cyrille Faraguet

given: Cyrille

family: Isly

full_name: Helene Isly

given: Helene

family: Rozenberg

full_name: Patrick Rozenberg

given: Patrick

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Perrotin

full_name: Franck Perrotin

given: Franck

name: for the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

ReferenceCitation: Diguisto C, Le Gouge A, Giraudeau B, Perrotin F. Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies. BMJ Open. 2017 Sep 14;7(9):e016069. doi: 10.1136/bmjopen-2017-016069.

location_facility:
Chu Rennes
Chu Brest
Ch Pontoise
Chu Reims
CHU CAEN
Ch Chartres
Chu Nantes
Hopital Saint Joseph
Chu Saint Etienne
Chu Toulouse
Ch Departemental Vendee
Chi Poissy
Chru Tours
Chu Clermont-Ferrand


title: Medicoeconomic Analysis of Lobectomy Using Thoracoscopy vs Thoracotomy for Lung Cancer: a Multicentric Randomized Controlled Trial.

summary:
This is a national study that involves the participation of 600 lung cancer patients indicated that treatment is ablation of the pulmonary lobe. This technique is called lobectomy.

Lobectomy may be performed in two different ways:

Thoracotomy, which is the first reference approach and that is to make a large incision in the chest to pass between the ribs and spread the order to ablate the lobe.
By video-thoracoscopy, which is a new surgical approach consisting in practice several small incisions in the chest wall to allow the introduction of a camera and special instruments to ablate the lobe.

The mini-invasive nature of video-thoracoscopy has a positive impact on postoperative expectoration and ventilation. As a result, the incidence of postoperative respiratory complications including atelectasis, pneumonia and Acute Respiratory Distress Syndrome (ARDS) is reduced. These respiratory complications are responsible for prolonged stays in Intensive Care Unit (ICU) and overall hospitalisation. It also has an impact on recovery and quality of life when patients return home. The reduction in the incidence of complications should counterbalance the additional cost of video-thoracoscopy.

This study aims to evaluate the effectiveness of these two techniques in relation to the quality of life and the costs they generate.

Patients who agree to participate in the study were assigned to one or other of these groups (technical thoracotomy or video-thoracoscopy technique) by lot.

status: Unknown status

ReferenceCitation: Pagès PB, Abou Hanna H, Bertaux AC, Serge Aho LS, Magdaleinat P, Baste JM, Filaire M, de Latour R, Assouad J, Tronc F, Jayle C, Mouroux J, Thomas PA, Falcoz PE, Marty-Ané CH, Bernard A. Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01). BMJ Open. 2017 Jun 15;7(6):e012963. doi: 10.1136/bmjopen-2016-012963.

family: Pagès

full_name: Pierre-Benoit Pagès

given: Pierre-Benoit

family: Abou Hanna

full_name: Halim Abou Hanna

given: Halim

family: Bertaux

full_name: Anne-Claire Bertaux

given: Anne-Claire

family: Serge Aho

full_name: Ludwig Serge Serge Aho

given: Ludwig Serge

family: Magdaleinat

full_name: Pierre Magdaleinat

given: Pierre

family: Baste

full_name: Jean-Marc Baste

given: Jean-Marc

family: Filaire

full_name: Marc Filaire

given: Marc

family: de Latour

full_name: Richard de Latour

given: Richard

family: Assouad

full_name: Jalal Assouad

given: Jalal

family: Tronc

full_name: François Tronc

given: François

family: Jayle

full_name: Christophe Jayle

family: Mouroux

full_name: Jérome Mouroux

given: Jérome

family: Thomas

full_name: Pascal-Alexandre Thomas

given: Pascal-Alexandre

family: Falcoz

full_name: Pierre-Emmanuel Falcoz

given: Pierre-Emmanuel

family: Marty-Ané

full_name: Charles-Henri Marty-Ané

given: Charles-Henri

family: Bernard

full_name: Alain Bernard

given: Alain

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
CHU de Rennes - Hôpital de Pontchaillou
APHM Hôpital Nord
HCL - Louis Pradel
CH Victor Dupouy
CHU Amiens
APHP Hôpital Cochin
CHU de Montpellier
CHU de Poitiers
CHU Dijon
APHP Hôpital de Tenon
HUS Strasbourg - Nouvel Hôpital Civil
Centre Jean Perrin - Clermont-Ferrand
CHU de Rouen
CH Avignon
CHU de Nice - Hôpital Pasteur


title: Study of Elderly Patients With Cancer and Seen in Consultation of Geriatric Oncology in the Nord Pas-de-Calais (CONSOG).

summary: The aim of this study is to establish a common geriatric oncology medical database. The patients concerned are the patients having benefited from a geriatric oncology consultation in one of the participating centres. This database is designed with a view on the one hand to better describe to better understand this population and on the other hand to facilitate the conduct of future retrospective or prospective studies on this population. The constitution of this observatory of patients seen in consultation should facilitate the development of studies from the analysis of data collected, and occasional surveys by the rapid identification of cases. Data from this database could provide clinicians with valuable informative elements of descriptive epidemiology and concerning the organization of care in the geriatric oncology field.

time_perspective: Other

lead_sponsor: Centre Oscar Lambret

location_facility:
Polyclinique de Riaumont
Centre de cancérologie Les Dentellières
Centre Oscar Lambret
CHRU de Lille
Centre Hospitalier d'Arras
Hospitalier Le Cateau-Cambresis
Centre Hospitalier
Hôpital Saint Vincent de Paul
Clinique Saint Jean, Roubaix
Hôpital Saint-Philibert
Centre Hospitalier, Douai


title: Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients: a Randomized Controlled Trial

acronym: ELECTROPAD

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life.

Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.

ReferenceCitation: Jéhannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahé G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.

name: Clinical Investigation Centre, INSERM, Rennes, France

family: Jéhannin

full_name: Pierre Jéhannin

name: Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland

family: Craughwell

full_name: Meghan Craughwell

given: Meghan

name: University Hospital of Rennes, Rennes, France

family: Omarjee

full_name: Loukman Omarjee

given: Loukman

family: Donnelly

full_name: Alan Donnelly

given: Alan

family: Jaquinandi

full_name: Vincent Jaquinandi

given: Vincent

family: Mahé

full_name: Guillaume Mahé

given: Guillaume

name: University of Rennes, M2S-EA 7470, Rennes, France

family: Le Faucheur

full_name: Alexis Le Faucheur

given: Alexis

journal_name: Vascular Medicine

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Rennes University Hospital

location_facility: Private Medical Office Arnaud Perrouillet


title: Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA A Multi-centre, Randomized, Non-comparative Phase II Study

acronym: OESIRI

summary:
The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy.

The hypotheses are as follows:

H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.

ReferenceCitation: Randrian V, Adenis A, Desrame J, Barbier E, Di Fiore F, Lièvre A, Dahan L, Laurent-Puig P, Mineur L, Breysacher G, Roquin G, Louafi S, Lopez A, Louvet C, Borg C, Metges JP, Faroux R, Gaba L, Manfredi S, Tougeron D. Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study. Dig Liver Dis. 2020 Mar;52(3):347-350. doi: 10.1016/j.dld.2019.11.014. Epub 2019 Dec 30.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hopital Européen
Chu Rouen
Chu Amiens
Chu Saint Louis
Chu de Poitiers
Institut Sainte Catherine
Ch Perpignan
Ch Le Raincy
Ch Duchenne


type: EudraCT Number

title: Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial

summary: The co-primary objectives will be to assess the safety and quality of life under treatment.

ReferenceCitation: Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5(3):224-37.

ReferenceCitation: Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9.

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

family: Borghaei

full_name: Hossein Borghaei

given: Hossein

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Horn

full_name: Leora Horn

given: Leora

family: Spigel

full_name: David R. Spigel

given: David R.

family: Steins

full_name: Martin Steins

given: Martin

family: Ready

full_name: Neal E. Ready

given: Neal E.

family: Chow

full_name: Laura Q. Chow

given: Laura Q.

family: Vokes

full_name: Everett E. Vokes

given: Everett E.

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Holgado

full_name: Esther Holgado

given: Esther

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Kohlhäufl

full_name: Martin Kohlhäufl

family: Arrieta

full_name: Oscar Arrieta

given: Oscar

family: Burgio

full_name: Marco Angelo Burgio

given: Marco Angelo

family: Fayette

full_name: Jérôme Fayette

given: Jérôme

family: Lena

full_name: Hervé Lena

given: Hervé

family: Poddubskaya

full_name: Elena Poddubskaya

given: Elena

family: Gerber

full_name: David E. Gerber

given: David E.

family: Gettinger

full_name: Scott N. Gettinger

given: Scott N.

family: Rudin

full_name: Charles M. Rudin

given: Charles M.

family: Rizvi

full_name: Naiyer Rizvi

given: Naiyer

family: Crinò

full_name: Lucio Crinò

given: Lucio

family: Blumenschein

full_name: George R. Blumenschein

title: Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

ReferenceCitation: Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

title: Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer

ReferenceCitation: Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferté C. Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928. doi: 10.1158/1078-0432.CCR-16-1741. Epub 2016 Nov 8.

ReferenceCitation: Daste A, Domblides C, Gross-Goupil M, Chakiba C, Quivy A, Cochin V, de Mones E, Larmonier N, Soubeyran P, Ravaud A. Immune checkpoint inhibitors and elderly people: A review. Eur J Cancer. 2017 Sep;82:155-166. doi: 10.1016/j.ejca.2017.05.044. Epub 2017 Jul 6. Review.

ReferenceCitation: Du-Thanh A, Lesage C, Ferreira E, Dereure O, Guillot B. [Innovative therapies for metastatic melanoma in elderly patients]. Ann Dermatol Venereol. 2015 Oct;142(10):549-56. doi: 10.1016/j.annder.2015.03.022. Epub 2015 May 16. Review. French.

ReferenceCitation: Extermann M. Measurement and impact of comorbidity in older cancer patients. Crit Rev Oncol Hematol. 2000 Sep;35(3):181-200. Review.

ReferenceCitation: Fitzsimmons D, Gilbert J, Howse F, Young T, Arrarras JI, Brédart A, Hawker S, George S, Aapro M, Johnson CD. A systematic review of the use and validation of health-related quality of life instruments in older cancer patients. Eur J Cancer. 2009 Jan;45(1):19-32. doi: 10.1016/j.ejca.2008.07.036. Epub 2008 Sep 25. Review.

ReferenceCitation: Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009 Feb;18(1):115-23. doi: 10.1007/s11136-008-9430-6. Epub 2008 Dec 23.

ReferenceCitation: Helissey C, Vicier C, Champiat S. The development of immunotherapy in older adults: New treatments, new toxicities? J Geriatr Oncol. 2016 Sep;7(5):325-33. doi: 10.1016/j.jgo.2016.05.007. Epub 2016 Jun 16. Review.

ReferenceCitation: Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Using reference data on quality of life--the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer. 1998 Aug;34(9):1381-9.

ReferenceCitation: Hua C, Boussemart L, Mateus C, Routier E, Boutros C, Cazenave H, Viollet R, Thomas M, Roy S, Benannoune N, Tomasic G, Soria JC, Champiat S, Texier M, Lanoy E, Robert C. Association of Vitiligo With Tumor Response in Patients With Metastatic Melanoma Treated With Pembrolizumab. JAMA Dermatol. 2016 Jan;152(1):45-51. doi: 10.1001/jamadermatol.2015.2707.

ReferenceCitation: Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J. 1992 Nov;11(11):3887-95.

ReferenceCitation: Khoja L, Day D, Wei-Wu Chen T, Siu LL, Hansen AR. Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review. Ann Oncol. 2017 Oct 1;28(10):2377-2385. doi: 10.1093/annonc/mdx286. Review.

ReferenceCitation: Lafage-Pochitaloff M, Costello R, Couez D, Simonetti J, Mannoni P, Mawas C, Olive D. Human CD28 and CTLA-4 Ig superfamily genes are located on chromosome 2 at bands q33-q34. Immunogenetics. 1990;31(3):198-201.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

name: From the Department of Medical Oncology, Royal Marsden Hospital, London (J.L.), and South West Wales Cancer Institute, Singleton Hospital, Swansea (J.W.) — both in the United Kingdom; Melanoma Oncology Unit, Veneto Region Oncology Research Institute, Padua (V.C.-S.), Oncology of Melanoma Unit, European Institute of Oncology, Milan (P.F.F.), University Hospital of Siena, Siena (M.M.), and Istituto Nazionale Tumori Fondazione Pascale, Naples (P.A.A.) — all in Italy; Division of Medical Oncology, University...

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.

ReferenceCitation: Michelson H, Bolund C, Brandberg Y. Multiple chronic health problems are negatively associated with health related quality of life (HRQoL) irrespective of age. Qual Life Res. 2000;9(10):1093-104.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: Naidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14. Review. Erratum in: Ann Oncol. 2016 Jul;27(7):1362.

ReferenceCitation: Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. doi: 10.1056/NEJMoa1603702. Epub 2016 Apr 19.

ReferenceCitation: Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. Epub 2016 Oct 8.

ReferenceCitation: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum in: Lancet. 2017 Apr 8;389(10077):e5.

ReferenceCitation: Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.

name: The authors' affiliations are listed in the Appendix.

title: Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib

ReferenceCitation: Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

title: Ipilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma

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name: on behalf of the EORTC Quality of Life Group

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Aberdeen University - Aberdeen University Research Archive

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.

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location_facility: Assistance Publique des Hôpitaux de Marseille


title: Epidemiology and Prognostic Impact of Social Deprivation Features in Intensive Care Unit Patients

acronym: PRECAREA

summary:
Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated.

In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.

ReferenceCitation: Marmot M, Allen J, Bell R, Bloomer E, Goldblatt P; Consortium for the European Review of Social Determinants of Health and the Health Divide. WHO European review of social determinants of health and the health divide. Lancet. 2012 Sep 15;380(9846):1011-29. doi: 10.1016/S0140-6736(12)61228-8. Epub 2012 Sep 8. Review.

ReferenceCitation: Welch CA, Harrison DA, Hutchings A, Rowan K. The association between deprivation and hospital mortality for admissions to critical care units in England. J Crit Care. 2010 Sep;25(3):382-90. doi: 10.1016/j.jcrc.2009.11.003. Epub 2010 Jan 15.

ReferenceCitation: Zager S, Mendu ML, Chang D, Bazick HS, Braun AB, Gibbons FK, Christopher KB. Neighborhood poverty rate and mortality in patients receiving critical care in the academic medical center setting. Chest. 2011 Jun;139(6):1368-1379. doi: 10.1378/chest.10-2594. Epub 2011 Mar 31.

ReferenceCitation: Latour J, López V, Rodriguez M, Nolasco A, Alvarez-Dardet C. Inequalities in health in intensive care patients. J Clin Epidemiol. 1991;44(9):889-94.

ReferenceCitation: Bein T, Hackner K, Zou T, Schultes S, Bösch T, Schlitt HJ, Graf BM, Olden M, Leitzmann M. Socioeconomic status, severity of disease and level of family members' care in adult surgical intensive care patients: the prospective ECSSTASI study. Intensive Care Med. 2012 Apr;38(4):612-9. doi: 10.1007/s00134-012-2463-x. Epub 2012 Jan 25.

ReferenceCitation: Bigé N, Hejblum G, Baudel JL, Carron A, Chevalier S, Pichereau C, Maury E, Guidet B. Homeless Patients in the ICU: An Observational Propensity-Matched Cohort Study. Crit Care Med. 2015 Jun;43(6):1246-54. doi: 10.1097/CCM.0000000000000944.

lead_sponsor: Centre Hospitalier de Saint-Denis

location_facility: Centre Hospitalier Universitaire Lariboisière

location_facility: Centre Hospitalier Universitaire Louis Mourier

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Intercommunal André Grégoire

location_facility: Centre Hospitalier Universitaire Ambroise Paré


ReferenceCitation: Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

ReferenceCitation: Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.

ReferenceCitation: Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43. doi: 10.1043/1543-2165(2007)131[18:ASOCCO]2.0.CO;2.

ReferenceCitation: Zhou BP, Hung MC. Dysregulation of cellular signaling by HER2/neu in breast cancer. Semin Oncol. 2003 Oct;30(5 Suppl 16):38-48. Review.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Untch M, Rezai M, Loibl S, Fasching PA, Huober J, Tesch H, Bauerfeind I, Hilfrich J, Eidtmann H, Gerber B, Hanusch C, Kühn T, du Bois A, Blohmer JU, Thomssen C, Dan Costa S, Jackisch C, Kaufmann M, Mehta K, von Minckwitz G. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results from the GeparQuattro study. J Clin Oncol. 2010 Apr 20;28(12):2024-31. doi: 10.1200/JCO.2009.23.8451. Epub 2010 Mar 22.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, Moliterni A, Vazquez F, Byakhov MJ, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Magazzù D, Heinzmann D, Steinseifer J, Valagussa P, Baselga J. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014 May;15(6):640-7. doi: 10.1016/S1470-2045(14)70080-4. Epub 2014 Mar 20. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

ReferenceCitation: Kute T, Stehle JR Jr, Ornelles D, Walker N, Delbono O, Vaughn JP. Understanding key assay parameters that affect measurements of trastuzumab-mediated ADCC against Her2 positive breast cancer cells. Oncoimmunology. 2012 Sep 1;1(6):810-821.

ReferenceCitation: Deauvieau F, Ollion V, Doffin AC, Achard C, Fonteneau JF, Verronese E, Durand I, Ghittoni R, Marvel J, Dezutter-Dambuyant C, Walzer T, Vie H, Perrot I, Goutagny N, Caux C, Valladeau-Guilemond J. Human natural killer cells promote cross-presentation of tumor cell-derived antigens by dendritic cells. Int J Cancer. 2015 Mar 1;136(5):1085-94. doi: 10.1002/ijc.29087. Epub 2014 Aug 6.

ReferenceCitation: Hernandez-Ilizaliturri FJ, Jupudy V, Ostberg J, Oflazoglu E, Huberman A, Repasky E, Czuczman MS. Neutrophils contribute to the biological antitumor activity of rituximab in a non-Hodgkin's lymphoma severe combined immunodeficiency mouse model. Clin Cancer Res. 2003 Dec 1;9(16 Pt 1):5866-73.

ReferenceCitation: Cornet S, Mathé D, Chettab K, Evesque A, Matera EL, Trédan O, Dumontet C. Pegfilgrastim Enhances the Antitumor Effect of Therapeutic Monoclonal Antibodies. Mol Cancer Ther. 2016 Jun;15(6):1238-47. doi: 10.1158/1535-7163.MCT-15-0759. Epub 2016 Mar 17.

ReferenceCitation: Cartron G, Zhao-Yang L, Baudard M, Kanouni T, Rouillé V, Quittet P, Klein B, Rossi JF. Granulocyte-macrophage colony-stimulating factor potentiates rituximab in patients with relapsed follicular lymphoma: results of a phase II study. J Clin Oncol. 2008 Jun 1;26(16):2725-31. doi: 10.1200/JCO.2007.13.7729. Epub 2008 Apr 21.

ReferenceCitation: Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27. Review.

ReferenceCitation: Lin Y, Kikuchi S, Obata Y, Yagyu K; Tokyo Research Group on Prevention of Gastric Cancer. Serum levels of transforming growth factor beta1 are significantly correlated with venous invasion in patients with gastric cancer. J Gastroenterol Hepatol. 2006 Feb;21(2):432-7.

ReferenceCitation: Tas F, Yasasever CT, Karabulut S, Tastekin D, Duranyildiz D. Serum transforming growth factor-beta1 levels may have predictive and prognostic roles in patients with gastric cancer. Tumour Biol. 2015 Mar;36(3):2097-103. doi: 10.1007/s13277-014-2817-9. Epub 2014 Nov 13.

ReferenceCitation: Lin Y, Kikuchi S, Tamakoshi A, Obata Y, Yagyu K, Inaba Y, Kurosawa M, Kawamura T, Motohashi Y, Ishibashi T; JACC Study Group. Serum transforming growth factor-beta1 levels and pancreatic cancer risk: a nested case-control study (Japan). Cancer Causes Control. 2006 Oct;17(8):1077-82.

ReferenceCitation: Zhao J, Liang Y, Yin Q, Liu S, Wang Q, Tang Y, Cao C. Clinical and prognostic significance of serum transforming growth factor-beta1 levels in patients with pancreatic ductal adenocarcinoma. Braz J Med Biol Res. 2016 Jul 25;49(8). pii: S0100-879X2016000800705. doi: 10.1590/1414-431X20165485.

ReferenceCitation: Tas F, Karabulut S, Yasasever CT, Duranyildiz D. Serum transforming growth factor-beta 1 (TGF-β1) levels have diagnostic, predictive, and possible prognostic roles in patients with melanoma. Tumour Biol. 2014 Jul;35(7):7233-7. doi: 10.1007/s13277-014-1984-z. Epub 2014 Apr 27.

ReferenceCitation: Xu S, Yang S, Sun G, Huang W, Zhang Y. Transforming growth factor-beta polymorphisms and serum level in the development of osteosarcoma. DNA Cell Biol. 2014 Nov;33(11):802-6. doi: 10.1089/dna.2014.2527. Epub 2014 Aug 6.

lead_sponsor: Centre Leon Berard

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre de Lutte contre le Cancer Jean Perrin

location_facility: Institut de Cancerologie Lucien Neuwirth

source: euctr

title: A Multicenter, Randomized, Open-label, Phase II Trial Aiming to Evaluate the Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Positive Breast Cancer Patients

summary: First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response. Therefore the investigators' proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter, randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab (Q3W).Stratification criteria will be: cN0 versus cN1.


title: Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position

summary: The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade

primary_purpose: Supportive Care

ReferenceCitation: Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.

family: Varobieff

full_name: Maxime Varobieff

given: Maxime

family: Choquet

full_name: Olivier Choquet

given: Olivier

family: Swisser

full_name: Fabien Swisser

given: Fabien

family: Coudray

full_name: Adrien Coudray

given: Adrien

family: Menace

full_name: Cecilia Menace

given: Cecilia

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Bringuier

full_name: Sophie Bringuier

given: Sophie

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.

full_name: Mathieu Capdevila

given: Mathieu

family: Saporito

full_name: Andrea Saporito

given: Andrea

family: Djanikian

full_name: Flora Djanikian

given: Flora

family: Marques

full_name: Martin Marques

given: Martin

journal_name: Anaesthesia Critical Care & Pain Medicine

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

evidence: open (author manuscript)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility:
University Hospital of Annecy
University hospital of Clermont-Ferrand
University hospital of Marseille
University hospital of limoges
University Hospital of Colmar
University hospital of Bordeaux
University Hospital of Montpellier
University Hospital of Reims
University hospital of Nice


ReferenceCitation: Sommerer C, Suwelack B, Dragun D, Schenker P, Hauser IA, Nashan B, Thaiss F. Design and rationale of the ATHENA study--A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial. Trials. 2016 Feb 17;17:92. doi: 10.1186/s13063-016-1220-9.

family: Sommerer

full_name: Claudia Sommerer

given: Claudia

family: Suwelack

full_name: Barbara Suwelack

given: Barbara

family: Dragun

full_name: Duska Dragun

given: Duska

family: Schenker

full_name: Peter Schenker

given: Peter

family: Hauser

full_name: Ingeborg A. Hauser

given: Ingeborg A.

family: Nashan

full_name: Björn Nashan

given: Björn

family: Thaiss

full_name: Friedrich Thaiss

given: Friedrich

journal_name: Trials

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Design and rationale of the ATHENA study – A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany France

acronym: ATHENA

title: 12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus

summary: This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.


acronym: EFFIPAP

summary:
This study is a multicentre, double-blind, randomized therapeutic trial.

The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage:

of platelet concentrates treated by pathogen reduction(Intercept amotosalen and UVA procedure)
compared with the usual platelet concentrates (in additive solution intersol), reference arm, and
compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS).

The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.

ReferenceCitation: Garban F, Guyard A, Labussière H, Bulabois CE, Marchand T, Mounier C, Caillot D, Bay JO, Coiteux V, Schmidt-Tanguy A, Le Niger C, Robin C, Ladaique P, Lapusan S, Deconinck E, Rolland C, Foote AM, François A, Jacquot C, Tardivel R, Tiberghien P, Bosson JL; Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) Study Group. Comparison of the Hemostatic Efficacy of Pathogen-Reduced Platelets vs Untreated Platelets in Patients With Thrombocytopenia and Malignant Hematologic Diseases: A Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):468-475. doi: 10.1001/jamaoncol.2017.5123.

name: University Grenoble Alpes, Centre National de Recherche Scientifique, Techniques de l'Ingénierie Médicale et de la Complexité–Institut Mathématiques Appliquées de Grenoble 38000, Grenoble, France

name: Service d’Hématologie, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France

name: Etablissement Français du Sang, Grenoble, France

family: Garban

full_name: Frédéric Garban

given: Frédéric

name: Centre d’Investigation Clinique 1406–Innovation Technologique, Institut national de la santé et de la recherche médicale, Grenoble, France

name: Service de Biostatistiques, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France

family: Guyard

full_name: Audrey Guyard

given: Audrey

name: Service d’Hématologie, Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France

family: Labussière

full_name: Helene Labussière

given: Helene

family: Bulabois

full_name: Claude-Eric Bulabois

given: Claude-Eric

name: Service d’Hématologie, Centre Hospitalier Universitaire de Rennes, Rennes, France

family: Marchand

full_name: Tony Marchand

given: Tony

name: Service d’Hématologie, Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, France

family: Mounier

full_name: Christiane Mounier

given: Christiane

name: Service d’Hématologie, Centre Hospitalier Universitaire de Dijon, Dijon, France

family: Caillot

full_name: Denis Caillot

given: Denis

name: Service d’Hématologie, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

name: Service d’Hématologie, Centre Hospitalier Universitaire de Lille, Lille, France

family: Coiteux

full_name: Valérie Coiteux

given: Valérie

name: Service d’Hématologie, Centre Hospitalier Universitaire d’Angers, Angers, France

family: Schmidt-Tanguy

full_name: Aline Schmidt-Tanguy

given: Aline

name: Service d’Hématologie, Centre Hospitalier Universitaire de Brest, Brest, France

family: Le Niger

full_name: Catherine Le Niger

given: Catherine

name: Service d’Hématologie, Hôpital Henri Mondor, Assistance Publique Hôpitaux de Paris, Créteil, France

family: Robin

full_name: Christine Robin

given: Christine

name: Service d’Hématologie, Institut Paoli Calmettes, Marseille, France

family: Ladaique

full_name: Patrick Ladaique

given: Patrick

name: Service d’Hématologie, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Paris, France

family: Lapusan

full_name: Simona Lapusan

given: Simona

name: Service d’Hématologie, Centre Hospitalier Universitaire de Besançon, Besançon, France

family: Deconinck

full_name: Eric Deconinck

given: Eric

family: Rolland

full_name: Carole Rolland

given: Carole

name: Cellule Publication, Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France

family: Foote

full_name: Alison M. Foote

given: Alison M.

name: Etablissement Français du Sang, La Plaine Saint-Denis, France

family: François

full_name: Anne François

given: Anne

family: Jacquot

full_name: Chantal Jacquot

given: Chantal

name: Etablissement Français du Sang, Rennes, France

family: Tardivel

full_name: René Tardivel

given: René

name: Unité mixte de recherche 1098, Institut national de la santé et de la recherche médicale, Université de Franche-Comté, Etablissement Français du Sang, Besançon, France

family: Tiberghien

full_name: Pierre Tiberghien

given: Pierre

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

name: for the Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) Study Group

location_facility:
CHU de Dijon
CHU de Clermont Ferrand
Hopital Saint Antoine
CHU de Besancon
Hospices Civils de Lyon - Lyon Sud
CHU de Grenoble
Institut Paoli Calmette
CHU Henri Mondor - APHP
CHU de Brest
Institut de Cancérologie de la Loire
CHU de Rennes
Hopital Huriez - CHRU Lille


title: Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting

summary: This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.

lead_sponsor: Hoffmann-La Roche


title: Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.

acronym: BUCiL

summary:
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.

In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.

The question is to know if this strategy is feasible in lung cancer.

ReferenceCitation: Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, André T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400.

ReferenceCitation: Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

family: Dediu

full_name: Mircea Dediu

given: Mircea

family: Thomas

full_name: Michael Thomas

given: Michael

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Sahoo

full_name: Tarini Prasad Sahoo

given: Tarini Prasad

family: Laack

full_name: Eckart Laack

given: Eckart

family: Reck

full_name: Martin Reck

given: Martin

family: Corral

full_name: Jesús Corral

given: Jesús

family: Melemed

full_name: Symantha Melemed

given: Symantha

family: John

full_name: William John

given: William

family: Chouaki

full_name: Nadia Chouaki

given: Nadia

family: Zimmermann

full_name: Annamaria H Zimmermann

given: Annamaria H

family: Visseren-Grul

full_name: Carla Visseren-Grul

given: Carla

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

journal_name: The Lancet Oncology

ReferenceCitation: Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.

name: From the Hôpital Saint-Antoine and Hôpital La Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Paris VI; L'Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche S 893, Paris; Hôpital Privé Jean Mermoz, Lyon; Institut Sainte-Catherine, Avignon; Hôpital Montfermeil, Montfermeil; Hôpital Foch, Suresnes; Hôpital de Senlis, Senlis; Hôpital Drevon, Dijon; Clinique Victor-Hugo, Le Mans; and Clinique de Courlancy, Reims, France.

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Maindrault-Goebel

full_name: Frédérique Maindrault-Goebel

given: Frédérique

family: Lledo

full_name: Gérard Lledo

given: Gérard

family: Mineur

publisher: American Society of Clinical Oncology (ASCO)

title: Can Chemotherapy Be Discontinued in Unresectable Metastatic Colorectal Cancer? The GERCOR OPTIMOX2 Study

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques


location_facility:
Polyclinique de Limoges - site Chénieux
Centre Alexis Vautrin
Centre Pierre Curie
Centre Oscar Lambret
Institut Jean Godinot
Hôpital Bretonneau
Hôpital Privé les Bonnettes
CMCO de la Côte d'Opale
CH Compiègne-Noyon
Centre Léonard de Vinci
Nouvelle Clinique des Dentellières
CHU Amiens- Hôpital Sud

title: A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer

summary: National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.


title: Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair

acronym: PROSPERE

summary:
The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.

It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.

lead_sponsor: University Hospital, Lille

location_facility: Groupe Hospitalier Diaconesses Croix St-Simon

location_facility: CH La Rochelle Service de Gynécologie Obstétrique

location_facility: CHRU de Lille - Service de Gynécologie médico chirurgicale

location_facility: Hôpital BICETRE / Service de Gynécologie Obstétrique

location_facility: CHI Poissy-St-Germain / Service de gynécologie


title: Ischemic Stroke and Early Vertical Positioning, the SEVEL Study: a Randomised Controlled Trial Comparing the 3 Months Rankin Score Outcome in Ischemic Stroke Patients; in Whom Early or Delayed Mobilization is Performed

acronym: SEVEL

summary: Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.

ReferenceCitation: Herisson F, Godard S, Volteau C, Le Blanc E, Guillon B, Gaudron M; SEVEL study group. Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial. PLoS One. 2016 Mar 29;11(3):e0149466. doi: 10.1371/journal.pone.0149466. eCollection 2016.

family: Herisson

full_name: Fanny Herisson

given: Fanny

family: Godard

full_name: Sophie Godard

given: Sophie

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Le Blanc

full_name: Emilie Le Blanc

given: Emilie

family: Guillon

full_name: Benoit Guillon

given: Benoit

family: Gaudron

full_name: Marie Gaudron

given: Marie

journal_name: PLOS ONE

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility:
Hospital
University Hospital
Hospital Yves LeFoll
Hospital Bretagne Atlantique
Hospital Cornouaille