title: EffecT of eARly analGesia With Erector Spinae Plane Block to Reduce Ventilation After Severe Chest Trauma: a Randomised Control Open-label Trial.

acronym: TARGET

summary: Blunt chest trauma is commonly associated with rib fractures and early pain management is a key goal after chest trauma. In spontaneous breathing patients, pain limits coughing efficiency and secretion clearance, thereby potentially leading to progressive atelectasis, loss of functional residual capacity (FRC) and, ultimately, respiratory distress. In patients under mechanical ventilation, pain interacts with the weaning of mechanical ventilation inducing an increase of the duration of invasive ventilation. According to recent French guidelines for chest trauma management, immediate analgesia is initially performed by intravenous multimodal analgesia followed by a thoracic epidural analgesia or a paravertebral block if the pain is not controlled within the first 12 hours. However, these blocks necessitate an experienced anaesthesiologist, are at risk of severe complications and are contraindicated in case of post-traumatic coagulopathy. All these considerations limit their indication in the trauma bay. The erector spinae plane (ESP) block is an easy to perform, ultrasound guided, regional anaesthesia for pain management after thoracic surgery. This block can be made continuously with a dedicated catheter for a continuous infusion of local anaesthetic drug with boli. The ESP block is performed by depositing the local anaesthetic in the fascial plane, deeper than the erector spinae muscle at the tip of the transverse process of the vertebra. This block is less invasive with fewer contraindications as compared to epidural analgesia or paravertebral blocks. After chest trauma, ESP block was associated with an improvement in respiratory capacity in a retrospective study. However, there is no randomised control trial assessing ESP efficacy. Our hypothesis is that early continuous ESP block in the trauma bay decreases the number of days with invasive and/or non-invasive ventilation after chest trauma.

status: Recruiting

ReferenceCitation: Veysi VT, Nikolaou VS, Paliobeis C, Efstathopoulos N, Giannoudis PV. Prevalence of chest trauma, associated injuries and mortality: a level I trauma centre experience. Int Orthop. 2009 Oct;33(5):1425-33. doi: 10.1007/s00264-009-0746-9. Epub 2009 Mar 6.

ReferenceCitation: Bachoumas K, Levrat A, Le Thuaut A, Rouleau S, Groyer S, Dupont H, Rooze P, Eisenmann N, Trampont T, Bohe J, Rieu B, Chakarian JC, Godard A, Frederici L, Gelinotte S, Joret A, Roques P, Painvin B, Leroy C, Benedit M, Dopeux L, Soum E, Botoc V, Fartoukh M, Hausermann MH, Kamel T, Morin J, De Varax R, Plantefeve G, Herbland A, Jabaudon M, Duburcq T, Simon C, Chabanne R, Schneider F, Ganster F, Bruel C, Laggoune AS, Bregeaud D, Souweine B, Reignier J, Lascarrou JB. Epidural analgesia in ICU chest trauma patients with fractured ribs: retrospective study of pain control and intubation requirements. Ann Intensive Care. 2020 Aug 27;10(1):116. doi: 10.1186/s13613-020-00733-0.

ReferenceCitation: Huber S, Biberthaler P, Delhey P, Trentzsch H, Winter H, van Griensven M, Lefering R, Huber-Wagner S; Trauma Register DGU. Predictors of poor outcomes after significant chest trauma in multiply injured patients: a retrospective analysis from the German Trauma Registry (Trauma Register DGU(R)). Scand J Trauma Resusc Emerg Med. 2014 Sep 3;22:52. doi: 10.1186/s13049-014-0052-4.

ReferenceCitation: Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16.

ReferenceCitation: Blondonnet R, Begard M, Jabaudon M, Godet T, Rieu B, Audard J, Lagarde K, Futier E, Pereira B, Bouzat P, Constantin JM. Blunt Chest Trauma and Regional Anesthesia for Analgesia of Multitrauma Patients in French Intensive Care Units: A National Survey. Anesth Analg. 2021 Sep 1;133(3):723-730. doi: 10.1213/ANE.0000000000005442.

ReferenceCitation: Koo CH, Lee HT, Na HS, Ryu JH, Shin HJ. Efficacy of Erector Spinae Plane Block for Analgesia in Thoracic Surgery: A Systematic Review and Meta-Analysis. J Cardiothorac Vasc Anesth. 2022 May;36(5):1387-1395. doi: 10.1053/j.jvca.2021.06.029. Epub 2021 Jun 29.

ReferenceCitation: Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

ReferenceCitation: White LD, Riley B, Davis K, Thang C, Mitchell A, Abi-Fares C, Basson W, Anstey C. Safety of Continuous Erector Spinae Catheters in Chest Trauma: A Retrospective Cohort Study. Anesth Analg. 2021 Nov 1;133(5):1296-1302. doi: 10.1213/ANE.0000000000005730.

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Clermont-Ferrand

location_facility: Hôpital Européen Georges Pompidou - AH-HP

location_facility: Hôpital d'Instruction des Armées Sainte Anne

status_simplified: Ongoing


type: Other Identifier

title: Impact of Bacterial Expression and Immune Response in the Severity of Pertussis

acronym: PERT-SEVEREII

summary:
The resurgence of pertussis is associated with an evolutionary mechanism under the pressure of current acellular vaccines, with a possible impact on vaccine effectiveness and disease expression. Little is known about the mechanisms involved in the clinical variability of pertussis, including its most severe malignant form observed in infants (mortality between 50-80%). The main challenges are: (i) the lack of knowledge about the gene expression of B. pertussis strains currently circulating during human infection, incorporating evolutionary changes and vaccine-induced selective pressure; (ii) the poor understanding of the variability in clinical expression of pertussis, and (iii) the lack of biomarkers to predict disease severity or prognosis in infants.

An integrative strategy combining a clinical, microbiological, immunological and 'omic' approach from a prospective cohort of children with pertussis will be used to identify

'in situ' expression profiles of B. pertussis genes and proteins incorporating recent evolutionary changes and
a systemic and respiratory immune signature in B. pertussis-infected children according to severity.

Results should furthermore serve as a prerequisite for the identification of severity biomarkers and new vaccine antigen candidates taking into account specific immune responses in infants.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Institut Pasteur

collaborators: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil

intervention_type: Biological

lead_sponsor_type: academique


title: SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®

acronym: SEMASEARCH

summary:
The aim of the SEMASEARCH project is therefore to constitute a retrospective cohort, from the available data on patients already included in the ATUc/AP2, and prospective, on new patients who will initiate treatment according to the AP2 PUT, of 15 Specialized Obesity Centers in order to describe the effect of WEGOVY® treatment in this population. Thanks to a high phenotyping, subpopulations of interest will be identified to know the specifics of the effect of the treatment in these subgroups of interest. Secondary analyses will aim to look for clinical or biological biomarkers of success in the weight response to WEGOVY® in the entire prospective cohort, but also in specific subpopulations.

In summary, the analysis of the entire SEMASEARCH cohort and sub-populations of interest will be based on a complete clinical phenotyping of patients (included in retrospective and prospective studies), completed by ad hoc questionnaires and associated with biological markers (prospective) partly collected within the framework of the WEGOVY® AP (glycaemia, hepatic assessment, lipid assessment ) and partly from a biobank to test specific hypotheses (predictive role of leptin sensitivity, insulin sensitivity level, plasma level of endocannabinoids, etc.).

In addition, approaches using artificial intelligence (AI), notably machine learning, will make it possible to determine the variables or combination of variables that are most predictive of the weight response to treatment with WEGOVY® in the largest population. Indeed, individual weight loss in response to weight loss strategies is highly variable, whether purely related to lifestyle changes or pharmacological. Well-known factors associated with the ability to lose weight include adherence to lifestyle change, gender, age and specific medications. However, after controlling for these factors, differences in weight loss appear to persist in response to different interventions including pharmacological ones. Adaptation to energy deficit involves complex feedback mechanisms, and inter-individual differences are likely to arise from a range of poorly defined factors. Thus, a better understanding of the factors involved in inter-individual variability in response to WEGOVY® will help guide more personalised approaches to the management of these patients. AI techniques will be used to determine which combination of clinical or biological variables are most predictive of weight response.

study_type: Observational

time_perspective: Other

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon

location_facility: Service Endocrinologie Diabétologie Nutrition APHP - Hôpital Jean Verdier

location_facility: Service Endocrinologie Diabétologie Maladies Métaboliques CHU François Mitterrand Dijon

location_facility: Service Endocrinologie Diabétologie Nutrition CHU de Nantes - Hôpital Guillaume & René Laennec

location_facility: Service de chirurgie APHP - GHU Nord Hôpital Louis Mourier

location_facility: Service Endocrinologie, Maladies Métaboliques et Nutrition Hôpital Rangueil (CHU Toulouse)

location_facility: Service Endocrinologie Diabétologie CHU de Grenoble

location_facility: Service Endocrinologie Hôpital Haut Léveque - CHU Bordeaux

location_facility: Service Endocrinologie Diabétologie Nutrition Hôpital Lapeyronie - CHU Montpellier

location_facility: Service Nutrition APHP - GHU Pitié Salpêtrière

location_facility: Service Nutrition Diabétologie Endocrinologie APHP - Hôpital Européen Georges-Pompidou (HEGP)

location_facility: Service Endocrinologie Diabète Nutrition Hôpitaux de Brabois - CHU Nancy

location_facility: Service Endocrinologie Diabétologie Nutrition CHU Poitiers

location_facility: Espace Médical Nutrition & Obésité (EMNO) Maison Médicale Valmy

location_facility: Service Endocrinologie Hôpital Conception - APHM

intervention_type: Other


title: Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.

acronym: OPTI-TWO

summary:
Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality.

The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu de Grenoble
Chu de Nimes
Chu de Nantes
Hopital Bichat Claude Bernard
Chu Clermont-Ferrand
Médipole Lyon Villeurbanne
Chu de Lille
APHM - Centre Hôpital Marseille Nord
Chu de Toulouse
Chu D'Amiens Picardie
Chu de Poitiers
Chu St-Etienne
Chru de Besancon
Chu Lyon Sud

intervention_type: Procedure


title: Added Value, Performance and Acceptance of the "GFAP-UCH-L1" Pair in the Evaluation of Subjects With Mild Traumatic Brain Injury (MTBI) at Intermediate Risk of Complications

acronym: GUEST

summary:
The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question :

• Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury?

Participants will do the exams planed in routine care and :

during the expected blood sampling an additional blood sample will be done,
seven days after the discharge a call will be done by the investigator.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Princesse Grace

collaborators: Centre Hospitalier Universitaire de Nīmes

collaborators: Centre Hospitalier Universitaire de Nice

location_country: Monaco France

location_facility: AP-HP Sorbonne Université, site Pitié-Salpêtrière

location_facility: Hôpital François Mitterrand - CHU de Dijon

location_facility: Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

acronym: GIG-T

summary:
The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing venous thromboembolic events (VTE) in good and intermediate prognosis patients with metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with risk factors for developing a thromboembolic event .

The high-risk patients will be randomized between two treatments arm (receiving a thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The low-risk patients will be observed without any thromboprophylaxis. Patients will participate in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy.

Researchers will compare an experimental arm with thromboprophylaxis and a control arm without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high risk patients, experimental arm).

primary_purpose: Supportive Care

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
CH de la Côte Basque
Institut de Cancérologie de Lorraine
Centre Léon Bérard
CHU de Poitiers
Centre Antoine Lacassagne
ICANS
ICO Paul Papin
CHU de Clermont-Ferrand
Gustave Roussy
CHU de Limoges
HIA Bégin
CHU Bretonneau
Centre Oscar Lambret
Clinique La Croix du Sud

intervention_type: Drug


title: Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis: Multicenter, Prospective, Placebo-controlled, Randomized Trial

acronym: CAESAR

summary:
Sarcoidosis is a systemic granulomatous disease of unknown aetiology, mainly affecting the lungs and lymphatics. It affects people worldwide (incidence, 4.7-64/100000; prevalence, 1-36/100000/year). Although it is most often a benign acute or subacute condition, sarcoidosis may progress to a disabling chronic disease in 25% of the cases, with severe complications in about 5%, such as lung fibrosis, cardiac or neurosarcoidosis, defacing lupus pernio or blindness due to uveitis.

When indicated, corticosteroids (CS) are the mainstay of treatment. Due to the kinetics of granuloma resolution, the usual and quite 'dogmatic' duration of treatment is said to be one year, following four classical steps. The long-term use of CS is hindered by cumulative toxicity and efforts have to be made to taper them, as quickly as possible, to the lowest effective dose. A recent report mentioned 39% of the CS-treated patients requiring a steroid-sparing agent. Chloroquine (CQ) and hydroxychloroquine (HCQ) are anti-malarial drugs that have been used since the 1960's as steroidsparing agents on the basis of a landmark study by Siltzbach reporting their efficacy in 43 patients with skin and intrathoracic sarcoidosis. Subsequently, two small randomized controlled trials have shown significant and prolonged improvement on pulmonary symptoms. Only small case series/reports have shown CQ/HCQ efficacy on extra-pulmonary sarcoidosis with response rates ranging from 67 to 100%. Nevertheless, CQ/HCQ are daily used for skin, bone, and joint sarcoidosis, as well as hypercalcemia. Nowadays, HCQ is preferred over CQ because of a lower incidence of gastrointestinal and ocular adverse reactions, which can be minimized by close attention to the dosage and regular retinal examination. Its profile of safety is well-known since it has long been employed to treat systemic lupus erythematous or rheumatoid arthritis. Its action is thought to rely on its ability to accumulate in lysosomes of phagocytic cells, to affect antigen presentation and reduce pro-inflammatory cytokines. The investigator hypothesize that HCQ may be an efficacious add-on therapy for extra-pulmonary sarcoidosis leading to a significant steroid-sparing effect.

primary_purpose: Treatment

location_facility: Service de Médecine Interne et Immunologie Clinique - Hôpital Sud

location_facility: Service de medecine interne - Hôpital Nord

location_facility: Service de medecine interne - Hôpital de Hautepierre

location_facility: Service de medecine interne - Hôpital Duputryen

location_facility: Service de Médecine Interne et Immunologie Clinique - CHU Dijon Bourgogne

location_facility: Service de Médecine Interne et maladies infectieuses - Hôpital Haut Lévêque

location_facility: Service de Médecine Interne Infectiologie Aïgue Polyvalente- Hôpital Henri Duffaud

location_facility: Service de medecine interne - Hôpital Saint Eloi

location_facility: Service de médecine interne - Hôpital de la Croix Rousse

location_facility: Service de medecine interne 2- Hôpital de la Pitié-Salpétrière

location_facility: Service de médecine interne - Hôpital Lariboisière

location_facility: Service de médecine interne - Hôpital Lyon Sud

location_facility: Service de medecine interne - Hôpital Claude Huriez

location_facility: Service de medecine interne - Hôpital Hôtel Dieu


title: Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion

acronym: ROBIICCA

summary:
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.

This is a three years interventional study involving adults with profound bilateral hearing loss.

Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.

lead_sponsor: Nantes University Hospital

location_facility:
AP-HP - la Pitié-Salpétrière
CHU de Saint-Etienne
Hopital Bicetre
CHRU de Tours
Brest University Hospital
Lille University Hospital
Michel
CHRU de Montpellier
CHRU Hautepierre
C.H.R. Pontchaillou
AP-HM
Bordeaux University Hospital
Chu Clermont Ferrand
CHU NICE


type: Registry Identifier

title: OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial: the OPTICOV Study

acronym: OPTICOV

summary: The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir/r)∞ versus the reference monotherapy (nirmatrelvir/r alone) and to assess the efficacy and safety of increasing the nirmatrelvir/r course from 5- to 10 days in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
University Hospital, Geneva

location_country: Switzerland France

location_facility:
Croix Rousse Hospital
Hotel Dieu Hospital
University Hospitals of Geneva
Saint-André Hospital
Bichat Claude-Bernard Hospital
Laribosière Hospital
Robert Debré Hospital
Saint Louis Hospital
Basel University Hospital
Saint Antoine Hospital
Pitié-Salpêtrière Hospital
University Hospital CHUV
La Colombière Hospital
Purpan Hospital
Pellegrin Hospital
Francois Mitterrand Hospital
Tourcoing Hospital
University Hospital Zurich


title: National Cohort of Colorectal Cancers With Microsatellite Instability

summary:
The three main pathways of colorectal carcinogenesis are chromosomal instability, microsatellite instability (MSI) (15% of colorectal cancers =CRCs) and CpG island methylator phenotype (CIMP). MSI CRCs are associated with a better prognosis after curative surgery than CRCs without microsatellite instability (MSS). In contrast, MSI CRCs do not appear to benefit from adjuvant 5-FU chemotherapy, unlike patients with MSS CRCs. Nevertheless, the benefit of adjuvant chemotherapy with FOLFOX seems to be retained. The identification of prognostic markers in this subgroup of patients is therefore essential to decide on adjuvant chemotherapy, the efficacy of which is currently debated in MSI CRC.

To date, there are very few data concerning metastatic MSI CRC. Metastatic forms are rare (about 5% of metastatic CRCs), but are thought to be associated with chemoresistance and poor prognosis. Nevertheless, data are very sparse and there are no data regarding the use of modern chemotherapies and targeted therapies in metastatic MSI CRC. Thus, it is important to characterize the chemosensitivity of metastatic forms.

Clinical predictors of recurrence after curative CRC surgery are known but have only been studied in MSI CRC retrospectively. Similarly, many molecular and immunohistochemical factors, prognostic or predictive of response to adjuvant chemotherapy, have been recently identified in CRC (KRAS, BRAF, TP53, PI3KCA mutations, CIMP phenotype, SMAD4, immune response...). Most of these markers have been studied in all CRCs, but not specifically in the MSI CRC subgroup. All these prognostic and/or predictive biomarkers need to be better characterized in a large cohort of MSI CRCs.

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Institut Du Cancer Avignon Provence

lead_sponsor_type: industriel


title: MULTICENTER OBSERVATIONAL STUDY OF THE OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

acronym: DEVENIR-IAM

summary: Acute ischemia of the lower limb (AMI) is a life-threatening emergency that threatens the functional prognosis of the limb. Depending on the clinical presentation and the anatomy of the patient, several therapeutic approaches can be considered: open surgery, endovascular surgery, hybrid surgery or amputation if revascularization is not feasible. The data in the current literature do not allow to clearly establish which therapeutic approach is the most adapted to the patient.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Reims University Hospital
APHP - Hôpital Mondor
APHP- Hôpital Bichat
Lyon University Hospital
Nantes University Hospital
Nancu University Hospital
Brest University Hospital
APHP- Hôpital Européen Georges Pompidou
Strasbourg University Hospital
APHP- Ambroise Paré
Besançon university hospital
Bordeaux University Hospital
Nice University Hospital
Dijon University Hospital


type: EudraCT Number

title: A Phase I-II Study to Assess Venetoclax + Azacitidine and Donor Lymphocyte Infusion in Patients With MDS or AML (Blasts < 30%) in Relapse After Allohematopoietic Stem Cell Transplantation

summary: Study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) with blasts < 30% in relapse after allohematopoietic stem cell transplantation (AHSCT).

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
AbbVie

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases

summary: Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Assistance Publique des Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Régional et Universaitaire de Tours

location_facility: Centre Hospitalier Universitaire de Lille

status_simplified: Completed


title: Assessment of the Quality of Life of Patients With Lymphomas Treated With Oral Therapy

acronym: EVEREST

summary:
The emergence of new anti-cancer drugs orally administered has revolutionized the prognosis and modalities of management of several lymphomas over the past decade. Today, half of patients receive oral therapy at home. Ibrutinib, acalabrutinib, idelalisib, venetoclax and lenalidomide are oral therapies used in the treatment of Chronic Lymphoid Leukemia, Follicular Lymphoma, Waldenström's disease and mantle cell lymphoma, in relapsing but soon to be 1st line.

Nevertheless, clinical trials leading to marketing authorizations for these drugs were performed in a small number of patients and very little data is available on their use in real life conditions. Their impact on the quality of life of patients also remains to be assessed.

The aim of this clinical research is to evaluate quality of life of patients at the initiation of the first oral therapy and every year for 5 years. This study will also identify factors (biological and non-biological: quality of life, shared decision-making ...) associated with a good response of patients and follow-up for the occurrence of long-term adverse reactions (5 years).

lead_sponsor: University Hospital, Toulouse

location_facility:
CH Le Mans
Centre Léon Bérard
CHU de Nîmes
CHU de Limoges
CH de Perpignan
CHU Clermont-Ferrand
CH Versailles
CHU de Montpellier
CHU de Grenoble
Hospices Civils de Lyon
Loïc YSEBAERT
CHU de Tours
CH de Bayonne
Institut Paoli Calmettes


title: A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

summary: Study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Astex Pharmaceuticals, Inc.

location_facility: CHU d'Angers - Service des maladies du sang

location_facility: CHU de Grenoble - Clinique Universitaire d'hématologie

location_facility: Hôpital Saint Eloi - Service hématologie clinique

location_facility: CHU Brabois - Service hématologie clinique

location_facility: CHRU de Limoges - Hôpital Dupuytren - Service hématologie clinique et thérapie cellulaire

location_facility: Hôpital Saint Louis - Service hématologie-greffe

location_facility: CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire

location_facility: CHU Hôtel Dieu - Service hématologie clinique

location_facility: CHU de Haut-Lévèque de Bordeaux - Service des maladies du sang

location_facility: Centre Henri Becquerel - Département d'hématologie

location_facility: Institut de Cancérologie Lucien Neuwirth - Hématologie clinique et thérapie cellulaire

location_facility: IUCT Oncopole - Département d'hématologie - Service de greffe de cellules souches hématopoïétiques

location_facility: CHU Estaing - Service hématologie clinique et thérapie cellulaire


title: Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour. A Double-blind, Randomised, Controlled Trial

acronym: PROXYMA

summary:
The rate of caesarean section is higher among obese pregnant women, leading to increased morbidity in this already vulnerable population. Oxytocin is the main drug used in obstetrics to optimize progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses.

We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical)

location_facility: CHU de Strasbourg (Hôpital de Hautepierre)

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PROXYMA

titre: Effet de l'augmentation de la dose d'oxytocin sur la voie d'accouchement chez les primipares obèses en travail spontané. Essai randomisé, controlé, en double aveugle

discipline_principale: obstétrique

nom_porteur: Pizzagalli

prenom_porteur: Franck


title: TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma: A Single-arm Phase 2 Trial

acronym: TALASUR

summary: The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
Pfizer

location_facility:
Centre George-François Leclerc
IUCT
Centre Léon Bérard
Croix Saint-Simon Diaconesses
Centre Antoine Lacassagne
Institut Paoli Calmettes
Hopital Tenon
Institut de Cancérologie de l'Ouest
Centre François baclesse
Centre Eugène Marquis
CHU Jean Minjoz
Hospices civils de Lyon
Centre Jean Perrin


title: Intelligent Evaluation of Diabetic Retinopathy

acronym: EviRed

summary: Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system.

location_facility: Clinique ophtalmologique du CHU de Nantes


acronym: HYVAPRESS

summary: The primary objective is to demonstrate the superiority of arginine-vasopressin (AVP) and hydrocortisone compared with norepinephrine regarding day-30 survival and neurological recovery in post-cardiac arrest patients with hemodynamic failure.

ReferenceType: background

ReferenceCitation: Witten L, Gardner R, Holmberg MJ, Wiberg S, Moskowitz A, Mehta S, Grossestreuer AV, Yankama T, Donnino MW, Berg KM. Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest. Resuscitation. 2019 Mar;136:93-99. doi: 10.1016/j.resuscitation.2019.01.031. Epub 2019 Jan 30.

location_facility: Intensive care unit, CHU Amiens- Picardie

location_facility: Intensive care unit, Hospices civils de Lyon

location_facility: Intensive care unit, Cochin hospital, APHP

location_facility: Intensive care unit, André Mignot hospital

location_facility: Medical Intensive Care Unit, Ambroise Paré hospital, APHP

location_facility: Intensive care unit, Clinique Ambroise Paré

location_facility: Intensive care unit, CHI Robert Ballanger

location_facility: Intensive care unit, Hôpital Jacques Cartier

location_facility: Intensive care unit, Hotel Dieu hospital

location_facility: Intensive care unit, CH public du Cotentin

title: HYdrocortisone and VAsopressin in Post-REsuscitation Syndrome

source: euctr

acronyme: HYVAPRESS

titre: Vasopressine et hydrocortisone dans l'état de choc post arrêt cardiaque

discipline_principale: anesthésiologie / réanimation

nom_porteur: GERI

prenom_porteur: Guillaume


title: Evolution of Ovarian Reserve in Severely Obese Women After Bariatric Surgery

acronym: BARIAOVO

summary:
The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. Severe obesity has negative effects on fertility and on in vitro fertilization (IVF) outcomes, and the weight loss induced by the bariatric surgery (BS) is believed to reverse the deleterious impact of overweight and obesity on female fertility. However, research is limited to retrospective cohort studies, small case-series and case-control studies. Weight reduction has been shown to improve fecundity and hormonal state of a subgroup of obese patients with polycystic ovary syndrome (PCOS). In this population, recent studies have demonstrated an increase of naturally conceived pregnancies following bariatric surgery. However, these studies have evaluated only short-term evolution of ovarian function and not all studies demonstrated improvements in fertility outcomes after BS. Clearly, more studies are needed regarding the effect of BS on obesity-related infertility, and long-term outcome of ovarian function has to be assessed.

Markers of ovarian reserve, including Follicle Stimulating Hormone (FSH), antral follicle count (AFC), and anti-mullerian hormone (AMH), have been used to counsel patients regarding in their reproductive outcomes. Serum AMH concentrations remain remarkably stable throughout the menstrual cycle, which is a great advantage over other markers of fertility. Various studies have evaluated the association between AMH and body mass index (BMI) but reported contradictory results. Some of them have reported a significant inverse correlation between AMH and BMI, but others found no relationship between AMH and BMI. Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH.

location_facility: CHU Dijon Bourgogne - Hôpital Le Bocage Sud

location_facility: AP-HP - Hôpital Europeen Georges Pompidou

location_facility: CHU Clermont Ferrand -Site Gabriel Montpied

location_facility: AP-HP - Groupe Hospitalier Pitié Salpêtrière

acronyme: BARIAOVO

titre: Evolution de la réserve ovarienne chez les femmes obèses après chirurgie bariatrique

discipline_principale: endocrinology / diabetes / metabolism and nutrition

nom_porteur: CIANGURA

prenom_porteur: Cecile


title: Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

acronym: Q-MIGAL

summary: Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

status: Unknown status

time_perspective: Cross-Sectional

ReferenceCitation: Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27.

ReferenceCitation: Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58. doi: 10.1002/ana.21211.

ReferenceCitation: Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42. doi: 10.1159/000067570.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CH Emile Roux Le Puy en Velay, Service de Neurologie

location_facility: CHU de Nice, Département Evaluation et Traitement de la Douleur

location_facility: Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie

location_facility: CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur

location_facility: CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie

location_facility: CHU de Montpellier, Service de Neurologie

location_facility: CHU de Clermont-Ferrand, Service de Neurologie

location_facility: Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur

location_facility: CH d'Annecy, Centre d'Etude et de Traitement de la Douleur

status_simplified: Unknown


title: Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study

acronym: SISCOVID

summary: The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility: Centre Hospitalier Le Raincy Montfermeil

location_facility: Centre Hospitalier de la Côte Basque - Bayonne

location_facility: Centre Hospitalier Régional Metz-Thioville

location_facility: Centre Hospitalier Départemental Vendée - La Roche sur Yon

location_facility: Centre Hospitalier Robert Boulin - Libourne

location_facility: Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace


title: French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

acronym: DELTA

summary: The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Institut de Médecine de la Reproduction (there may be other sites in this country)

location_facility: Centre hospitalier de Lille-Hopital de Flandre


acronym: PEVOsq

lead_sponsor: UNICANCER

summary: Interventional study evaluating the efficacy of an immunotherapy (pembrolizumab) in combination with a targeted therapy (vorinostat) in patient with recurrent and/or metastatic squamous cell carcinoma (localisations : head and neck, lung, cervix, anus, vulva, and penis)

sponsor_collaborators:
UNICANCER
Merck Sharp & Dohme LLC
Fondation ARC
ERA-NET

location_facility: Institut de Cancérologie de l'Ouest (site René Gauducheau)

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

title: Phase II Basket Trial Evaluating the Efficacy of a Combination of Pembrolizumab and Vorinostat in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma

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.


title: Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas

acronym: NEONEC

summary:
NEONEC is a single-phase, phase II study evaluating the efficacy of the 12-month neoadjuvant chemotherapy in patients with locally differentiated digestive NEC. The recommended chemotherapy is based on the current reference combination of platinum (cisplatin or carboplatin) and etoposide (VP16). For anorectal locations, radiochemotherapy is proposed to avoid the morbidity of conventional surgery.

The objective of the study is to improve relapse-free survival (RFS) in NEC patients treated with neoadjuvant chemotherapy followed by surgery or chemoradiotherapy.

In parallel, we will perform a prospective cohort study with patients whose diagnosis is made during surgery, who have not received neoadjuvant treatment, and who are offered an adjuvant treatment of the same type (combination of platinum and platinum salts and etoposide).

design_allocation: Non-Randomized

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


title: Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.

acronym: OptiTHO

summary:
In blunt chest trauma patients without immediate life-threatening conditions, delayed respiratory failure and need for mechanical ventilation may still occur in 12 to 40% of patients, depending on the severity of the trauma, the preexisting conditions and the intensity of initial management.

In this context, non-invasive ventilation (NIV) is recommended in hypoxemic chest trauma patients, defined as a PaO2/FiO2 ratio < 200 mmHg. However, there is a large heterogeneity among studies regarding the severity of injuries, the degree of hypoxemia and the timing of enrollment. The interest of a preventive strategy during the early phase of blunt chest trauma, before the occurrence of respiratory distress or severe hypoxemia, is not formally established in the literature. Moreover, high-flow nasal oxygen therapy (HFNC-O2) appears to be a reliable and better tolerated alternative to conventional oxygen therapy (COT), associated with a significant reduction in intubation rate in hypoxemic patients.

Two NIV strategies are compared:

In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio < 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days.
In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 > 92%. NIV is initiated only in patients having PaO2/FiO2 ratio < 200 mmHg under COT.

Investigators hypothesized that an early strategy associating HFNC-O2 and preventive NIV in hypoxemic blunt chest trauma patients may reduce the need for mechanical ventilation compared to the recommended strategy associating COT and late NIV.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Strasbourg -Hôpital de Hautepierre

intervention_type: Combination Product

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: OptiTHO

titre: Evaluation d'une stratégie d'oxygénation et de ventilation non invasive préventive à la phase aiguë d'un traumatisme thoracique hypoxémique. Etude randomisée.

discipline_principale: anesthesiology / resuscitation

nom_porteur: BIAIS

prenom_porteur: Matthieu


title: Phase III Trial to Assess Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI Outcomes in Infertile Women Presenting With Adenomyosis.

acronym: ADENOFIV

summary:
Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids.

Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation.

For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available:

the long protocol involving a 15 days pituitary down-regulation;
the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study

status: Withdrawn

location_facility: Centre hospitalier intercommunal de Créteil

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: adenofiv

titre: Phase III évaluant l'impact d'un blocage de 3 mois par analogue de la GnRH sur le devenir après FIV/ICSI de patientes infertiles porteuses d'une adénomyose

discipline_principale: médecine de la reproduction

nom_porteur: Vidal

prenom_porteur: Fabien


title: Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion

acronym: KINEPANCH

summary: The main purpose of this study is to assess efficacy of non instrumental pleural chest physiotherapy on the recovery of respiratory function, at hospital discharge or 15 days after beginning the pleural chest physiotherapy, compared to physiotherapy with standard mobilization, in patients with infectious pleural effusion, who have received usual medical treatment.

lead_sponsor: Hôpital NOVO

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Intercommunal - Créteil

location_facility: Centre Hospitalier Henri Duffaut - Avignon

appel_a_projets: PHRIP

nom_etablissement: HOPITAL NOVO

acronyme: KINEPANCH

titre: Efficacité de la kinésithérapie respiratoire pleurale (KRP) dans la prise en charge initiale des épanchements pleuraux infectieux : Etude multicentrique randomisée contrôlée.

discipline_principale: pneumologie

nom_porteur: MONTRELAY

prenom_porteur: Frédérique


title: Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.

summary:
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

ReferenceCitation: Le Duc G, Miladi I, Alric C, Mowat P, Brauer-Krisch E, Bouchet A, Khalil E, Billotey C, Janier M, Lux F, Epicier T, Perriat P, Roux S, Tillement O. Toward an image-guided microbeam radiation therapy using gadolinium-based nanoparticles. ACS Nano. 2011 Dec 27;5(12):9566-74. doi: 10.1021/nn202797h. Epub 2011 Nov 9.

ReferenceCitation: Lux F, Tran VL, Thomas E, Dufort S, Rossetti F, Martini M, Truillet C, Doussineau T, Bort G, Denat F, Boschetti F, Angelovski G, Detappe A, Cremillieux Y, Mignet N, Doan BT, Larrat B, Meriaux S, Barbier E, Roux S, Fries P, Muller A, Abadjian MC, Anderson C, Canet-Soulas E, Bouziotis P, Barberi-Heyob M, Frochot C, Verry C, Balosso J, Evans M, Sidi-Boumedine J, Janier M, Butterworth K, McMahon S, Prise K, Aloy MT, Ardail D, Rodriguez-Lafrasse C, Porcel E, Lacombe S, Berbeco R, Allouch A, Perfettini JL, Chargari C, Deutsch E, Le Duc G, Tillement O. AGuIX(R) from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine. Br J Radiol. 2019 Jan;92(1093):20180365. doi: 10.1259/bjr.20180365. Epub 2018 Sep 18.

ReferenceCitation: Verry C, Dufort S, Barbier EL, Montigon O, Peoc'h M, Chartier P, Lux F, Balosso J, Tillement O, Sancey L, Le Duc G. MRI-guided clinical 6-MV radiosensitization of glioma using a unique gadolinium-based nanoparticles injection. Nanomedicine (Lond). 2016 Sep;11(18):2405-17. doi: 10.2217/nnm-2016-0203. Epub 2016 Aug 16.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
NH TherAguix SAS

location_facility: Hospices Civils de Lyon-Hôpital Lyon Sud

location_facility: Institut de Cancérologie de Lorraine ALEXIS VAUTRIN

location_facility: Centre Hospitalier Universitaire Grenoble-Alpes

location_facility: Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie


title: A Prospective, Multicentre Phase II Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas (LENVOS)

acronym: LENVOS

summary: This study evaluates the combination of lenvatinib with denosumab in bone-predominant metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas. All patients will receive this combination of treatments.

lead_sponsor: Centre Leon Berard

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Est

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Phase 2 Study of Ponatinib (Iclusig) for Prevention of Relapse After Allogeneic Stem Cell Transplantation (Allo-SCT) in FLT3-ITD AML Patients: the PONALLO Trial."

acronym: PONALLO

summary:
Recent advances in acute myeloid leukemia (AML) have been characterized by a better understanding of disease biology. As such, FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) have been recognized as conferring a poor prognosis. The FLT3-ITD molecular mutation is observed in about one-quarter of patients diagnosed with AML. Patients presenting with this abnormality are referred for early allogeneic stem-cell transplantation (allo-SCT). However, some data suggest that FLT3-ITD remains associated with a poor prognosis even after allo-SCT because of higher risk of relapse and strategies for preventing relapse in the post-transplant setting are required (Hu et al, Expert Rev Hematol, 2014). For example, in a large cohort of patients (Brunet et al, JCO, 2012), the incidence of relapse for FLT3-ITD AML patients after allo-SCT was 30% at 2-years, significantly higher compared to FLT3-ITD negative patients (p=0.006).

Ponatinib (Iclusig®) is an orally available, tyrosine kinase inhibitor with a unique binding mechanism allowing inhibition of BCR-ABL kinases, including those with the T315I point mutation. Ponatinib also has in vitro inhibitory activity against a discrete set of kinases implicated in the pathogenesis of other hematologic malignancies, including FLT3, KIT, fibroblast growth factor receptor 1 (FGFR1), and platelet derived growth factor receptor α (PDGFRα). In vitro activity of ponatinib in AML has been already demonstrated (Gozgit et al, Mol Cancer Ther, 2011; Smith et al, Blood 2013). If some trials are on-going to test ponatinib alone or in combination with chemotherapy in FLT3-ITD AML (Clinical.trials.gov), no study is dedicated to the use of ponatinib in the post-transplant setting in order to prevent relapse in these patients.

The main goal of this study will be to determine the maximal tolerated dose (MDT) of ponatinib after allo-SCT in FLT3-ITD AML patients, then to investigate the efficacy of ponatinib in a larger cohort of patients

lead_sponsor: Versailles Hospital

location_facility:
CHU Grenoble
CHu Brest
CRLC Toulouse
CHU Lille
Hopital St Antoine
Chevallier
CHU Poitiers
CHU Caen
CHU Limoges
CHU Clermont Ferrand
CHU Nancy
CHU Angers
Hopital St Louis
CHu Lyon


title: Prevalence and Vulnerability Factors of Active Cybersexuality Among Teenagers (15 - 17 Olds) in West Normandy.

summary: This study evaluates prevalence of active cybersexuality among teenagers (15-17 old) in West Normandy and find different factors of vulnerability that could induce this behaviour. Selection of teenagers in different schools (general, professional, agricultural, reintegration structure).

ReferenceCitation: Braun-Courville DK, Rojas M. Exposure to sexually explicit Web sites and adolescent sexual attitudes and behaviors. J Adolesc Health. 2009 Aug;45(2):156-62. doi: 10.1016/j.jadohealth.2008.12.004. Epub 2009 Feb 20.

ReferenceCitation: Strassberg DS, McKinnon RK, Sustaita MA, Rullo J. Sexting by high school students: an exploratory and descriptive study. Arch Sex Behav. 2013 Jan;42(1):15-21. doi: 10.1007/s10508-012-9969-8. Epub 2012 Jun 7.

ReferenceCitation: Temple JR, Paul JA, van den Berg P, Le VD, McElhany A, Temple BW. Teen sexting and its association with sexual behaviors. Arch Pediatr Adolesc Med. 2012 Sep;166(9):828-33. doi: 10.1001/archpediatrics.2012.835.

ReferenceCitation: Strassberg DS, Cann D, Velarde V. Sexting by High School Students. Arch Sex Behav. 2017 Aug;46(6):1667-1672. doi: 10.1007/s10508-016-0926-9. Epub 2017 Jan 3.

ReferenceCitation: Rice E, Gibbs J, Winetrobe H, Rhoades H, Plant A, Montoya J, Kordic T. Sexting and sexual behavior among middle school students. Pediatrics. 2014 Jul;134(1):e21-8. doi: 10.1542/peds.2013-2991.

lead_sponsor: University Hospital, Caen

location_facility:
ICEP CFA
Lycée Laplace
Lycée Allende
EPEI
La roquelle
MFR
CIFAC
Lycée marie curie
Cfai Uimm
MFR TRUN
IME
Lycée de navarre
Lycée Millet
Lycée jules verne


title: Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.

acronym: TOPTACOS

summary:
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.

The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.

This series of questionnaires will aim to identify:

the gradient of compliance of the patient with his treatment,
all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
the evolution of patient compliance during their treatment course,
a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
University of Angers, GRANEM
Fondation ARC

location_facility:
CHP Océane
Clinique Pasteur Saint Esprit
Clinique Mutualiste de l'Estuaire
CHU
Centre Hospitalier
CHD Vendée
Centre Catherine de Sienne
CHU Morvan
Institut de Cancérologie de l'Ouest
Clinique Victor Hugo
Centre Eugène Marquis
CHP
CHIC Quimper


title: Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer

acronym: FOCALE

summary: The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

lead_sponsor: Hospices Civils de Lyon

location_country: Sweden France

location_facility: Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

location_facility: Service d'Urologie, Clinique Tivoli Ducos

location_facility: Service d'Urologie CHRU de Lille, Hôpital HURIEZ

location_facility: Département d'Urologie, Institut Montsouris

location_facility: Hôpital L. Pasteur, Hôpitaux Civils de Colmar

location_facility: Clinique Générale Beaulieu - Swiss International Prostate Center

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

location_facility: Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

location_facility: Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,


title: Multicentre Observational Study on Community Acquired Intraabdominal Infections Management: the PERICOM Study

acronym: PERICOM

summary: Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.

ReferenceType: derived

ReferenceCitation: Roger C, Garrigue D, Bouhours G, Dupont H, Bouzat P, Bardon J, Pottecher J, Montravers P, Michelet P, Perbet S, Aymart K, Incagnoli P, Lloret S, Louart B, Harrois A; ACUTE committee. Time to source control and outcome in community-acquired intra-abdominal infections: The multicentre observational PERICOM study. Eur J Anaesthesiol. 2022 Jun 1;39(6):540-548. doi: 10.1097/EJA.0000000000001683.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU d'Amiens
Ap Hm La Timone
CHU Grenoble La Tronche
Hôpital Henri Mondor
Hia Percy
AP HM La Timone
CHU Nimes
CHU Clermont-Ferrand
Lyon-Sud Pierre Bénite
CHRU Lille
CHU Bichat Claude Bernard
Le Kremlin-Bicêtre
CHU Strasbourg
CHU Angers


title: Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer

acronym: HIFUSA

summary:
The percentage of malignant prostate tumors detected very early is constantly increasing and the number of well differentiated tumors, with small volume and low risk of progression increases. When a tumor of this type is identified, radical prostatectomy remains the reference treatment, but this treatment is not without side effects. Active surveillance is a strategy which aims at detecting an early development of the cancerous disease in order to propose curative treatment in a timely manner and thus improve specific survival. Patients are therefore re-evaluated each year by rectal examination, PSA (Prostate-Specific Antigen) assay. Active surveillance remains difficult to manage psychologically for both the patient and the practitioner, because of the lack of treatment on the one hand and a rate of non-curable cancers close to 50% when signs of progression trigger a radical treatment.

The aim of the focal treatment HIFU (High Intensity Focused Ultrasound) is to destroy the cancer without causing side effects in contrast to radical treatments. It is in this sense that it is positioned both as an alternative to radical surgery and as an alternative to active surveillance.

location_facility: Service d'Urologie, CHU de Guebwiller Colmar


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

ReferenceCitation: Ambrosoli R, Di Stasio L, Mazzocco P. Content of alpha S1-casein and coagulation properties in goat milk. J Dairy Sci. 1988 Jan;71(1):24-8. doi: 10.3168/jds.S0022-0302(88)79520-X.

ReferenceCitation: Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.

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.

ReferenceCitation: Forsyth BW, McCarthy PL, Leventhal JM. Problems of early infancy, formula changes, and mothers' beliefs about their infants. J Pediatr. 1985 Jun;106(6):1012-7. doi: 10.1016/s0022-3476(85)80260-2.

ReferenceCitation: Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.

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, Lonnerdal 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. doi: 10.1093/ajcn/51.1.37.

ReferenceCitation: Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6.

ReferenceCitation: Long T, Johnson M. Living and coping with excessive infantile crying. J Adv Nurs. 2001 Apr;34(2):155-62. doi: 10.1046/j.1365-2648.2001.01740.x.

ReferenceCitation: Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.

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. doi: 10.1136/adc.84.3.273.

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. doi: 10.1177/000992289903801202.

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. doi: 10.1093/pch/16.3.147.

ReferenceCitation: Recio I, Perez-Rodriguez 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. doi: 10.1017/s0022029997002343.

ReferenceCitation: Savino F, Cresi F, Maccario S, Cavallo F, Dalmasso P, Fanaro S, Oggero R, Vigi V, Silvestro L. "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. Acta Paediatr Suppl. 2003 Sep;91(441):86-90. doi: 10.1111/j.1651-2227.2003.tb00653.x.

ReferenceCitation: Zhou SJ, Sullivan T, Gibson RA, Lonnerdal B, Prosser CG, Lowry DJ, Makrides M. Nutritional adequacy of goat milk infant formulas for term infants: a double-blind randomised controlled trial. Br J Nutr. 2014 May;111(9):1641-51. doi: 10.1017/S0007114513004212. Epub 2014 Feb 6.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

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


title: Diagnostic Accuracy of the ATE Score for the Exclusion of Intra-atrial Thrombi Before Catheter Ablation of Atrial Fibrillation: a Confirmatory Study

acronym: EXTRALUCID

summary:
Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. Despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination.

A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no hypertension, no history of stroke, d-dimer < 270 ng/mL, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus.

The objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ATE score for the exclusion of intra-atrial thrombus.

ReferenceCitation: Milhem A, Ingrand P, Treguer F, Cesari O, Da Costa A, Pavin D, Rivat P, Badenco N, Abbey S, Zannad N, Winum PF, Mansourati J, Maury P, Bader H, Savoure A, Sacher F, Andronache M, Allix-Beguec C, De Chillou C, Anselme F; ATE Study Group. Exclusion of Intra-Atrial Thrombus Diagnosis Using D-Dimer Assay Before Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):223-230. doi: 10.1016/j.jacep.2018.09.009. Epub 2018 Nov 1.

publisher_dissemination: Elsevier

ReferenceCitation: Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001 Jun 13;285(22):2864-70. doi: 10.1001/jama.285.22.2864.

ReferenceCitation: Natale A, Mohanty S, Goldstein L, Gomez T, Hunter TD. Real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation. J Interv Card Electrophysiol. 2021 Apr;60(3):445-452. doi: 10.1007/s10840-020-00734-w. Epub 2020 May 11.

ReferenceCitation: Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

ReferenceCitation: Scherr D, Dalal D, Chilukuri K, Dong J, Spragg D, Henrikson CA, Nazarian S, Cheng A, Berger RD, Abraham TP, Calkins H, Marine JE. Incidence and predictors of left atrial thrombus prior to catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2009 Apr;20(4):379-84. doi: 10.1111/j.1540-8167.2008.01336.x. Epub 2008 Oct 27.

ReferenceCitation: Puwanant S, Varr BC, Shrestha K, Hussain SK, Tang WH, Gabriel RS, Wazni OM, Bhargava M, Saliba WI, Thomas JD, Lindsay BD, Klein AL. Role of the CHADS2 score in the evaluation of thromboembolic risk in patients with atrial fibrillation undergoing transesophageal echocardiography before pulmonary vein isolation. J Am Coll Cardiol. 2009 Nov 24;54(22):2032-9. doi: 10.1016/j.jacc.2009.07.037.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Service de cardiologie, CH Annecy Genevois

location_facility: Service de cardiologie, Centre Hospitalier du pays d'Aix

location_facility: Service de cardiologie, CHU Saint Etienne

location_facility: Service de cardiologie, CHR Metz Thionville

location_facility: Service de cardiologie, Hôpital privé du Confluent

location_facility: Service de cardiologie, Clinique Saint Joseph

intervention_type: Diagnostic Test


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: Terminated

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

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


title: Observational, Real-life Study of the Use of octaplasLG®.

summary: This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.

lead_sponsor: Octapharma

location_facility: Hospices Civils de Lyon Hôpital Edouard Herriot


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.

lead_sponsor: Centre Hospitalier Princesse Grace

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: AP-HP Centre Hospitalier Universitaire Henri-Mondor

location_facility: Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Carémeau

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units

acronym: DELIREA

summary:
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment.

The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.

ReferenceCitation: Aissaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.

ReferenceCitation: Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x.

ReferenceCitation: Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.

ReferenceCitation: Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.

ReferenceCitation: Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

ReferenceCitation: Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71. doi: 10.1080/00029157.1976.10403794. No abstract available.

ReferenceCitation: Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.

ReferenceCitation: Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.

ReferenceCitation: McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hospital
University Hospital Toulouse
Saint-André Hospital
Perpignan Hospital
Estaing Hospital
Oncologic Hospital
Gabriel Montpied
Saint-Joseph Hospital
Montauban Hospital
Hospital Castres-Mazamet
Rangueil Hospital
Caremeau Hospital
Nord Hospital
Jacques Puel Hospital

acronyme: DELIREA

titre: Impact des mesures de prévention non pharmacologiques sur l'incidence du delirium en réanimation polyvalente adulte. Etude multicentrique interventionnelle contrôlée randomisée en clusters.

nom_porteur: SILVA

prenom_porteur: Stein


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

collaborators: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE

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


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

lead_sponsor: Associazione Qol-one

location_country: Italy Greece France

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: "G.Gennimatas" General Hospital of Athens

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

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: "George Papanicolaou General Hospital of Thessaloniki

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


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.

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 Obstetrique et Gynecologie (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.

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 - Diderot

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

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.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Tours

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

intervention_type: Device

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: MAG POP

titre: Comparaison de deux stratégies de maturation cervicale chez les femmes en terme dépassé : maturation mécanique versus maturation pharmacologique. Essai randomisé contrôlé, ouvert, multicentrique.

nom_porteur: PERROTIN