title: Efficacy and Safety of Total Pancreatectomy With Intraportal Islet Autotransplantation for Resectable Adenocarcinoma of the Cephalic Region of the Pancreas at High-risk of Postoperative Fistula and Requiring Systemic Adjuvant Chemotherapy

summary:
Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula.

Postoperative complications following pancreaticoduodenectomy can lead to early discontinuation of the complete oncologic strategy, i.e., chemotherapy for malignancy is performed in only about a third of patients who experienced a grade C fistula.

A total pancreatectomy rather than a pancreaticoduodenectomy is an alternative procedure that involves the complete and definitive resection of all pancreatic tissue, eliminating any risk of postoperative pancreatic fistula but is associated with unavoidable endocrine insufficiency and potentially severe metabolic complications, such as "brittle diabetes".

Total Pancreatectomy following by intraportal Islet AutoTransplantation (TPIAT) can prevent "brittle diabetes" and improve the quality of life. The endocrine islets can be isolated from the pancreatic surgical specimen with standardized procedures and transplanted in the liver through intraportal infusion, in absence of immunosuppression and allow adequate control of glucose metabolism with a reduced need for exogenous insulin and an effective graft function in 70% of cases at 3 years Thereby, the investigators hypothesize that total pancreatectomy with intraportal Islet autotransplantation rather than classical pancreaticuduodenectomy, in patients with high-risk of postoperative fistula will increase the rate of complete access to adjuvant chemotherapy, while maintaining an adequate metabolic control.


study_start_date_type: Anticipated

acronym: IRONCEL

intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
The study aims is to evaluate the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). This randomized multicenter trial compare the administration of intravenous iron by infusion (Ferinject©: 15 mg/kg in NaCl solution in 30 min) and oral iron in combination; to patients receive only oral iron as standard care.

The first benefit with IV Iron supplementation is to correct iron deficiency more rapidly than oral iron alone because of trouble of absorption in case of intestinal villous atrophy.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

status: Not yet recruiting

title: Effect of Intravenous Iron Supplementation on Celiac Disease Remission in Patients With Iron Deficiency and Intestinal Villous Atrophy: a Randomized Trial

primary_purpose: Treatment

type: EudraCT Number

type: Other Grant/Funding Number

source: euctr

enrollment_type: Anticipated

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

design_allocation: Randomized

study_completion_date_type: Anticipated

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: IRONCEL

titre: Efficacite de la supplementation intraveineuse en fer dans la guerison de la maladie coeliaque chez les malades avec carence martiale et atrophie villositaire intestinale: essai randomise

discipline_principale: gastro-entérologie

nom_porteur: Malamut

prenom_porteur: Georgia


study_start_date_type: Actual

acronym: ACTIVE

summary:
The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.

This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.

location_facility: AP-HP, Hôpital Européen Georges Pompidou

status: Recruiting

title: ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

acronyme: ACTIVE

titre: Etude randomisée contrôlée évaluant l'intérêt de l'acide tranexamique et de la terlipressine par voie nébulisée dans le traitement initial de l'hémoptysie menaçante

discipline_principale: pneumologie

nom_porteur: PLANQUETTE

prenom_porteur: Benjamin


type: Other Identifier

title: DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule

summary: Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.

primary_purpose: Other

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

intervention_type: Procedure

appel_a_projets: PREPS

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

titre: Distinguer les enfants suivis pour cancer à bas risque d'infection sévère en cas de neutropénie fébrile-7 : étude d'impact d'une règle de décision clinique

discipline_principale: organisation des soins

nom_porteur: DUBOS

prenom_porteur: François


title: Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)

acronym: PROMICI

summary:
The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.

The secondary objectives are:

to assess the level of education and compare it to that of the general population

to assess occupational insertion and the educational level according to:

The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
sex
Age at diagnosis (<or ≥ 10 years)
The occurence of surgery, the location of the disease, the treatments undertaken
Quality of life
Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

status: Unknown status

study_type: Observational

time_perspective: Cross-Sectional

status_simplified: Unknown


title: Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

acronym: QALY-ECOPED

summary: The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

appel_a_projets: PRME

acronyme: EPIMAD-ECOPED

titre: Evaluation économique des modalités de prise en charge des MICI pédiatriques à partir des données du registre EPIMAD

nom_porteur: Dervaux

prenom_porteur: Benoit


title: Efficacy of Rheopheresis as Adjuvant Treatment of Calciphylaxis in Hemodialysis Patients : a Prospective Randomized Controled Single-blind Trial

acronym: RHEO-CAL

summary: We propose to set up a prospective randomized controlled trial to control the security and assess the efficacy of adjuvant treatment by rheopheresis in necrotizing-ulcered calciphylaxis in the hemodialysis population.

status: Enrolling by invitation

primary_purpose: Diagnostic

acronyme: RHEOCAL

titre: EFFICACITÉ DE LA RHEOPHÉRÈSE EN TRAITEMENT ADJUVANT DE LA CALCIPHYLAXIE DU PATIENT EN HEMODIALYSE CHRONIQUE: UNE ÉTUDE PROSPECTIVE RANDOMISÉE EN SIMPLE AVEUGLE

discipline_principale: néphrologie

nom_porteur: LIONET

prenom_porteur: Arnaud


title: A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.

summary:
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".

To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.

Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.

Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.

intervention_type: Combination Product

appel_a_projets: PHRCI

titre: Etude pilote sur la faisabilité et la tolérance d'une radiothérapie stéréotaxique néo-adjuvante par CYBERKNIFE° avant résection de carcinome hépatocellulaire uninodulaire.

discipline_principale: carcinome hépatocellulaire, résection hépatique, radiothérapie stéréotaxique, traitements néoadjuvants, faisabilité

nom_porteur: BOLESLAWSKI

prenom_porteur: Emmanuel


type: Registry Identifier

title: Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma

summary: The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.

status: Completed

ReferenceType: background

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.

ReferenceCitation: Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.

ReferenceCitation: Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.

intervention_type: Radiation

status_simplified: Completed

titre: Etude prospective évaluant la combinaison des Tomographies par Émission de Positons au 18F-FDG et à la 18 F-Fluorocholine pour l'optimisation du staging et la modification du traitement chez des patients atteints de carcinome hépatocellulaire

discipline_principale: cancer

nom_porteur: NAULT

prenom_porteur: Jean-Charles


title: Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke

acronym: DETERMINE

summary: DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

ReferenceType: derived

ReferenceCitation: Maier B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E; DETERMINE Investigators. Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial. Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel


title: Prevention of pneumonIA in Nursing hOme

acronym: PIANO

summary: Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Ministry of Health, France

intervention_type: Other


title: Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.

acronym: PLANCO-ISO

summary:
For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team.

That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated.

One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

acronyme: PLANCO-ISO

titre: IMPACT DU PLAN DE CRISE CONJOINT SUR LA DURÉE DES MESURES D'ISOLEMENT EN PSYCHIATRIE

discipline_principale: psychiatrie / addictologie

nom_porteur: QUENUM

prenom_porteur: Yvonne


title: Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability

acronym: CAIDiag

summary: Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.

time_perspective: Prospective

location_facility: CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport

nom_etablissement: CH REGION DE ST-OMER

acronyme: CAIDiag-Therapy

titre: Analyse biomécanique, examens complémentaires et prise en charge rééducative des instabilités chroniques de cheville

discipline_principale: instabilité chronique de cheville, rééducation, biomécanique, aide au diagnostic, accompagnement thérapeutique

nom_porteur: POPINEAU

prenom_porteur: Christophe


title: Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome

acronym: APECED

summary: The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated


title: Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label

acronym: NUTRILEAK

summary:
The incidence of clinically significant anastomotic leaks (AL) after upper gastrointestinal (GI) surgery is approximately 4 % - 20 %, and the associated mortality can be as high as 80 % . Nutritional support is a key component of therapy in such cases, related to high prevalence of malnutrition and nil per month required for leak treatment.

In the prophylactic setting, before the occurrence of any AL, a literature review based on seven randomised trials showed that enteral nutrition (EN) is associated with shorter hospital stay, lower incidence of severe of infectious complications, lower severity of complications and decreased cost compared to parenteral nutrition (TPN) following major upper GI surgery .

In the curative setting, after the AL occurrence, very few evidence is available. Only one randomized clinical trial suggested the superiority of EN versus TPN after pancreatic surgery with a increase of the 30-day fistula closure rate from 37% in the TPN group to 60% in the EN group .

This sole randomised study available did not include all postoperative upper GI AL (PUGIAL) that can occur after esophageal, gastric, duodenal, pancreatic surgery (including obesity surgery), whereas the concept of enteral nutritional support is highly relevant for all these situations.

However surgeons are usually reluctant to provide EN in case of AL. A randomized study suggested the feasibility of EN in 47 patients with upper GI AL but no randomized study to date has been designed to test the superiority of EN versus TPN in PUGIAL.

The study aim is to demonstrate the superiority of EN versus TPN to accelerate AL healing after upper GI surgery.

Hypothesis:

EN increases the 30-day fistula closure rate in PUGIAL, allowing better HRQOL without increasing morbi-mortality.

ReferenceCitation: Gronnier C, Chambrier C, Duhamel A, Dervaux B, Collet D, Vaudoyer D, Regimbeau JM, Jougon J, Thereaux J, Lebreton G, Veziant J, Valverde A, Ortega-Deballon P, Pattou F, Mathonnet M, Perinel J, Beyer-Berjot L, Fuks D, Rouanet P, Lefevre JH, Cattan P, Deguelte S, Meunier B, Tuech JJ, Pessaux P, Carrere N, Salame E, Benaim E, Dousset B, Msika S, Mariette C, Piessen G; FRENCH association. Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study). Trials. 2020 Jun 2;21(1):448. doi: 10.1186/s13063-020-04366-3.

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square
univOAK

acronyme: NUTRILEAK

titre: Nutrition entérale versus parentérale dans le traitement conservateur d'une fistule post-opératoire du tube digestif supérieur

discipline_principale: chirurgie viscérale et digestive

nom_porteur: MARIETTE


title: Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)

summary:
Objective

To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries


title: Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH

acronym: NASHSURG

summary: The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).

acronyme: NASHsurg

titre: Etude randomisée évaluant la chirurgie bariatrique comme traitement de la stéatohépatite non alcoolique sévère avec fibrose hépatique avancée chez le patient obèse non sévère

discipline_principale: hépatologie

nom_porteur: MATHURIN

prenom_porteur: Philippe


title: Does Nurse Semi - Structured Interview Added to a Repeated Transcranial Magnetic Stimulation Improve Patients With Major Depressive Disorder? A Single Center Study, Randomized, Controlled and Single Blind

acronym: DESTIMCARE

summary:
Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. FDA approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded .

Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice.

The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship.

No study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: DESTIMCARE

titre: Évaluation de l'adjonction d'un entretien infirmier semi  directif à la stimulation magnétique transcrânienne répétée dans la prise en charge des patients présentant un épisode dépressif majeur.Etude monocentrique, randomisée, contrôlé,en simple aveugle

nom_porteur: BROUSSE

prenom_porteur: Stéphane


title: MOther-Child Interaction Assessment TRAINING for Pediatricians

acronym: MOCITRAINING

summary: The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

primary_purpose: Supportive Care

acronyme: MOCITRAINING

titre: Formation des pédiatres ambulatoires à l'évaluation des interactions précoces mère-enfant.

nom_porteur: JARDRI

prenom_porteur: Renaud


title: Determinants of Patients' Uptake of Therapeutic Education Programme

acronym: UTEP

summary:
Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to the Health Belief Model, patient will participate in TPE if they perceive their disease as a serious threat (with possible serious complications), but which can be controlled however, and that TPE is efficient and represents little burden.

Secondary aims are as follows:

To test whether the way TPE is presented to patients impact patients' decision to uptake TPE. The way TPE is presented comprises the time between diagnosis and the proposal of TPE, whether patient is a remission or crisis period in the disease, the time between the proposal and the next TPE session, and what is said by healthcare professionals to present TPE.
To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
To test whether patients' intention to participate in TPE will predict their actual participation.

The ultimate goal of the study is to identify patients whose beliefs will not favor participation in TPE in order to accompany those patients more carefully. Best practices will be proposed according the results.

acronyme: Protocole UTEP

titre: Déterminants de la participation initiale des patients à un programme d'Éducation Thérapeutique

nom_porteur: BOURGOIN

prenom_porteur: Maryline


title: Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

acronym: CGH Array

summary:
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.

This research aims to:

to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
assist in the diagnosis of these fetuses and genetic information for their families,
identify new regions of the genome potentially involved in the occurrence of congenital malformations.

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness

summary:
In the complex process of organ transplant, two of the major steps are:

evaluation of the organs of potential donors in health institutions:
proposing grafts to the transplant teams, according to rules defined at the national level.

In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.

The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).

The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.

ReferenceCitation: Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.

ReferenceCitation: Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.

ReferenceCitation: Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89. Erratum In: Radiol Technol. 2012 May-Jun;83(5):446.

ReferenceCitation: Fregeville A, De Bazelaire C, Zagdanski A, Albiter M, Desgrandchamps F, De Kerviler E. [Value of whole body CTA in the management of brain-dead patients]. J Radiol. 2010 Jan;91(1 Pt 1):37-44. doi: 10.1016/s0221-0363(10)70004-4. French.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

ReferenceCitation: Zarca K, Dupont JK, Jacoud L, Bulsei J, Huot O, Logerot H, Durand-Zaleski I. Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol. BMC Health Serv Res. 2019 Sep 18;19(1):672. doi: 10.1186/s12913-019-4488-0.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

intervention_type: Device


title: Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over

acronym: SARCOLD

summary: In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Ministry of Health, France

region: Nouvelle-Aquitaine

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: SARCOLD

titre: Evaluation de l'impact du traitement locorégional des Sarcomes des Tissus Mous sur l'état fonctionnel des patients âgés de 70 ans et plus

discipline_principale: chirurgie, oncogériatrie, sarcomes cancer

nom_porteur: MERTENS

prenom_porteur: Cécile


summary: Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).

title: Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial

titre: Antibiothérapie chez les patients présentant une trachéobronchite acquise sous ventilation mécanique: étude propsective randomisée contrôlée multicentrique

discipline_principale: anesthésiologie / réanimation

nom_porteur: NSEIR

prenom_porteur: Saad


title: Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo

acronym: AscaMC

summary: This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.

ReferenceCitation: Sendid B, Salvetat N, Sarter H, Loridant S, Cunisse C, Francois N, Aijjou R, Gele P, Leroy J, Deplanque D, Jawhara S, Weissmann D, Desreumaux P, Gower-Rousseau C, Colombel JF, Poulain D. A Pilot Clinical Study on Post-Operative Recurrence Provides Biological Clues for a Role of Candida Yeasts and Fluconazole in Crohn's Disease. J Fungi (Basel). 2021 Apr 22;7(5):324. doi: 10.3390/jof7050324.

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

publisher_dissemination: MDPI


title: Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study

acronym: ePPOP-ID

summary: The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.

ReferenceCitation: Deruelle P, Lelorain S, Deghilage S, Couturier E, Guilbert E, Berveiller P, Senat MV, Vayssiere C, Sentilhes L, Perrotin F, Gallot D, Chauleur C, Sananes N, Roth E, Luton D, Caputo M, Lorio E, Chatelet C, Couster J, Timbely O, Doret-Dion M, Duhamel A, Pigeyre M. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery. BMC Pregnancy Childbirth. 2020 Oct 7;20(1):602. doi: 10.1186/s12884-020-03288-x.

intervention_type: Behavioral

acronyme: ePPOP ID

titre: Programme d'accompagnement personnalisé électronique pour une prise en charge de l'obésité au cours de la grossesse afin d'améliorer l'accouchement

discipline_principale: obstétrique

nom_porteur: DERUELLE


title: Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa

summary: Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.


title: EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest

acronym: EMERGE

summary:
Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic.

Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%).

Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.

ReferenceCitation: Hauw-Berlemont C, Lamhaut L, Diehl JL, Andreotti C, Varenne O, Leroux P, Lascarrou JB, Guerin P, Loeb T, Roupie E, Daubin C, Beygui F, Boissier F, Marjanovic N, Christiaens L, Vilfaillot A, Glippa S, Prat JD, Chatellier G, Cariou A, Spaulding C; EMERGE Investigators. Emergency vs Delayed Coronary Angiogram in Survivors of Out-of-Hospital Cardiac Arrest: Results of the Randomized, Multicentric EMERGE Trial. JAMA Cardiol. 2022 Jul 1;7(7):700-707. doi: 10.1001/jamacardio.2022.1416.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

acronyme: EMERGE

titre: Coronarographie immédiate ou secondaire chez les survivants d'un arrêt cardiaque extra-hospitalier sans cause extra-cardiaque

discipline_principale: médecine d'urgence

nom_porteur: SPAULDING

prenom_porteur: Christian


acronym: ACTICAS

summary:
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity. The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of hypocalcemia.

Hypoparathyroidism can also be caused by an autoimmune process. In rare cases, hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive, autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs association of active vitamin D and hydrochlorothiazide. The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range.

title: A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism

acronyme: ACTICAS

titre: Essai randomisé en cross over comparant la PTH(1-34) recombinante humaine à l'association alfacalcidol-hydrochlorothiazide dans le traitement de l'hypocalcémie autosomique dominante

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: BLANCHARD

prenom_porteur: Anne


title: Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial

acronym: PaCUDAHL-Gé

summary: This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.

ReferenceCitation: Fishbein M. A reasoned action approach to health promotion. Med Decis Making. 2008 Nov-Dec;28(6):834-44. doi: 10.1177/0272989X08326092. Epub 2008 Nov 17.

ReferenceCitation: van Baars R, Bosgraaf RP, ter Harmsel BW, Melchers WJ, Quint WG, Bekkers RL. Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol. 2012 Dec;50(12):3937-43. doi: 10.1128/JCM.01506-12. Epub 2012 Sep 26.

ReferenceCitation: Viguier J, Calazel-Benque A, Eisinger F, Pivot X. Organized colorectal cancer screening programmes: how to optimize efficiency among general practitioners. Eur J Cancer Prev. 2011 Jan;20 Suppl 1:S26-32. doi: 10.1097/01.cej.0000391567.49006.af.

ReferenceCitation: Verhoef VM, Bosgraaf RP, van Kemenade FJ, Rozendaal L, Heideman DA, Hesselink AT, Bekkers RL, Steenbergen RD, Massuger LF, Melchers WJ, Bulten J, Overbeek LI, Berkhof J, Snijders PJ, Meijer CJ. Triage by methylation-marker testing versus cytology in women who test HPV-positive on self-collected cervicovaginal specimens (PROHTECT-3): a randomised controlled non-inferiority trial. Lancet Oncol. 2014 Mar;15(3):315-22. doi: 10.1016/S1470-2045(14)70019-1. Epub 2014 Feb 13.

ReferenceCitation: Duport N, Serra D, Goulard H, Bloch J. [Which factors influence screening practices for female cancer in France?]. Rev Epidemiol Sante Publique. 2008 Oct;56(5):303-13. doi: 10.1016/j.respe.2008.07.086. Epub 2008 Oct 31. French.

ReferenceType: result

ReferenceCitation: Anhang R, Nelson JA, Telerant R, Chiasson MA, Wright TC Jr. Acceptability of self-collection of specimens for HPV DNA testing in an urban population. J Womens Health (Larchmt). 2005 Oct;14(8):721-8. doi: 10.1089/jwh.2005.14.721.

ReferenceCitation: Haguenoer K, Giraudeau B, Gaudy-Graffin C, de Pinieux I, Dubois F, Trignol-Viguier N, Viguier J, Marret H, Goudeau A. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study. Gynecol Oncol. 2014 Aug;134(2):302-8. doi: 10.1016/j.ygyno.2014.05.026. Epub 2014 Jun 3.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Cadman L, Ashdown-Barr L, Waller J, Szarewski A. Attitudes towards cytology and human papillomavirus self-sample collection for cervical screening among Hindu women in London, UK: a mixed methods study. J Fam Plann Reprod Health Care. 2015 Jan;41(1):38-47. doi: 10.1136/jfprhc-2013-100705. Epub 2014 Feb 12.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceCitation: Waller J, Bartoszek M, Marlow L, Wardle J. Barriers to cervical cancer screening attendance in England: a population-based survey. J Med Screen. 2009;16(4):199-204. doi: 10.1258/jms.2009.009073.

ReferenceCitation: Cox JT, Castle PE, Behrens CM, Sharma A, Wright TC Jr, Cuzick J; Athena HPV Study Group. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol. 2013 Mar;208(3):184.e1-184.e11. doi: 10.1016/j.ajog.2012.11.020. Epub 2012 Nov 19.

ReferenceCitation: Park Y, Lee E, Choi J, Jeong S, Kim HS. Comparison of the Abbott RealTime High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 assays to direct sequencing and genotyping of HPV DNA. J Clin Microbiol. 2012 Jul;50(7):2359-65. doi: 10.1128/JCM.00337-12. Epub 2012 Apr 18.

ReferenceCitation: TOMBOLA Group. Cytological surveillance compared with immediate referral for colposcopy in management of women with low grade cervical abnormalities: multicentre randomised controlled trial. BMJ. 2009 Jul 28;339:b2546. doi: 10.1136/bmj.b2546.

ReferenceCitation: Rigal L, Saurel-Cubizolles MJ, Falcoff H, Bouyer J, Ringa V. Do social inequalities in cervical cancer screening persist among patients who use primary care? The Paris Prevention in General Practice survey. Prev Med. 2011 Sep;53(3):199-202. doi: 10.1016/j.ypmed.2011.06.016. Epub 2011 Jun 25.

ReferenceCitation: Chan Chee C, Begassat M, Kovess V. [Factors associated with cervical cancer screening in women covered by national health insurance]. Rev Epidemiol Sante Publique. 2005 Feb;53(1):69-75. doi: 10.1016/s0398-7620(05)84573-0. French.

ReferenceCitation: Zehbe I, Moeller H, Severini A, Weaver B, Escott N, Bell C, Crawford S, Bannon D, Paavola N. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from Northwest Ontario, Canada: a pilot study. BMJ Open. 2011 Feb 26;1(1):e000030. doi: 10.1136/bmjopen-2010-000030.

ReferenceCitation: Goodman A. HPV testing as a screen for cervical cancer. BMJ. 2015 Jun 30;350:h2372. doi: 10.1136/bmj.h2372.

ReferenceCitation: Gok M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Belien JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010 Mar 11;340:c1040. doi: 10.1136/bmj.c1040. Erratum In: BMJ. 2016 May 18;353:i2823.

ReferenceCitation: Broberg G, Gyrd-Hansen D, Miao Jonasson J, Ryd ML, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial. Int J Cancer. 2014 May 1;134(9):2223-30. doi: 10.1002/ijc.28545. Epub 2013 Oct 31.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Grillo F, Vallee J, Chauvin P. Inequalities in cervical cancer screening for women with or without a regular consulting in primary care for gynaecological health, in Paris, France. Prev Med. 2012 Mar-Apr;54(3-4):259-65. doi: 10.1016/j.ypmed.2012.01.013. Epub 2012 Jan 24.

ReferenceCitation: Elfstrom KM, Smelov V, Johansson AL, Eklund C, Naucler P, Arnheim-Dahlstrom L, Dillner J. Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial. BMJ. 2014 Jan 16;348:g130. doi: 10.1136/bmj.g130.

ReferenceCitation: Gok M, Heideman DA, van Kemenade FJ, de Vries AL, Berkhof J, Rozendaal L, Belien JA, Overbeek L, Babovic M, Snijders PJ, Meijer CJ. Offering self-sampling for human papillomavirus testing to non-attendees of the cervical screening programme: Characteristics of the responders. Eur J Cancer. 2012 Aug;48(12):1799-808. doi: 10.1016/j.ejca.2011.11.022. Epub 2011 Dec 13.

ReferenceCitation: Bulk S, Bulkmans NW, Berkhof J, Rozendaal L, Boeke AJ, Verheijen RH, Snijders PJ, Meijer CJ. Risk of high-grade cervical intra-epithelial neoplasia based on cytology and high-risk HPV testing at baseline and at 6-months. Int J Cancer. 2007 Jul 15;121(2):361-7. doi: 10.1002/ijc.22677. Erratum In: Int J Cancer. 2007 Oct 15;121(8):1873.

ReferenceCitation: Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmeron J, Uribe P, Velasco-Mondragon E, Nevarez PH, Acosta RD, Hernandez-Avila M. Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. Lancet. 2011 Nov 26;378(9806):1868-73. doi: 10.1016/S0140-6736(11)61522-5. Epub 2011 Nov 1.

ReferenceCitation: Cullen J, Schwartz MD, Lawrence WF, Selby JV, Mandelblatt JS. Short-term impact of cancer prevention and screening activities on quality of life. J Clin Oncol. 2004 Mar 1;22(5):943-52. doi: 10.1200/JCO.2004.05.191.

ReferenceCitation: C Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J. The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds. Health Technol Assess. 2014 Apr;18(23):1-196. doi: 10.3310/hta18230.

publisher_dissemination: National Institute for Health and Care Research

ReferenceCitation: Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F; Self-Sampling Study Working Group. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). Br J Cancer. 2011 Jan 18;104(2):248-54. doi: 10.1038/sj.bjc.6606040. Epub 2010 Dec 21.

ReferenceCitation: Favre J, Rochoy M, Raginel T, Pelletier M, Messaadi N, Deken-Delannoy V, Duhamel A, Berkhout C. The Effect of Cervical Smears Performed by General Practitioners on the Cervical Cancer Screening Rate of their Female Patients: A Claim Database Analysis and Cross-Sectional Survey. J Womens Health (Larchmt). 2018 Jul;27(7):933-938. doi: 10.1089/jwh.2017.6656. Epub 2018 Mar 27.

ReferenceCitation: Rochoy M, Raginel T, Favre J, Soueres E, Messaadi N, Deken V, Duhamel A, Berkhout C. Factors associated with the achievement of cervical smears by general practitioners. BMC Res Notes. 2017 Dec 8;10(1):723. doi: 10.1186/s13104-017-2999-5.

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

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

repositories_institution: Université de Lille (University Of Lille) - LillOA


title: Effect of the Type of Maternal Pushing During the Second Stage of Labor on Obstetric and Neonatal Outcome: a Multicenter Randomized Trial

acronym: EOLE

summary: The objective of this randomized clinical trial is to assess and compare the effectiveness of directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed open-glottis pushing (pushing during a prolonged exhalation) during the second stage of labor. The study hypothesis is that open-glottis pushing results in better maternal and neonatal outcomes, in particular for maternal pelvic floor and continence function.

ReferenceCitation: Barasinski C, Debost-Legrand A, Savary D, Bouchet P, Curinier S, Vendittelli F. Does the type of pushing at delivery influence pelvic floor function at 2 months postpartum? A pragmatic randomized trial-The EOLE study. Acta Obstet Gynecol Scand. 2023 Jan;102(1):67-75. doi: 10.1111/aogs.14461. Epub 2022 Nov 9.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

ReferenceCitation: Barasinski C, Vendittelli F. Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol. BMJ Open. 2016 Dec 20;6(12):e012290. doi: 10.1136/bmjopen-2016-012290.

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

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Ministry of Health, France


title: Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study

summary:
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .

Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.

design_allocation: Non-Randomized

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service d'Endocrinologie - CHU Saint-Etienne


title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study

acronym: GAEL

summary: The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

ReferenceCitation: Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.

evidence: open (via free pdf)

publisher_dissemination: Daedalus Enterprises

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Ministry of Health, France


title: Renal Denervation in Patients With Resistant Hypertension

acronym: DENER-HTN

summary: The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

ReferenceCitation: Hamdidouche I, Gosse P, Cremer A, Lorthioir A, Delsart P, Courand PY, Denolle T, Halimi JM, Girerd X, Ormezzano O, Rossignol P, Pereira H, Azizi M; DENERHTN Investigators. Clinic Versus Ambulatory Blood Pressure in Resistant Hypertension: Impact of Antihypertensive Medication Nonadherence: A Post Hoc Analysis the DENERHTN Study. Hypertension. 2019 Nov;74(5):1096-1103. doi: 10.1161/HYPERTENSIONAHA.119.13520. Epub 2019 Sep 23.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Courand PY, Pereira H, Del Giudice C, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Lantelme P, Denolle T, Dourmap C, Halimi JM, Girerd X, Rossignol P, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Bouhanick B, Mourad JJ, Ferrari E, Chatellier G, Sapoval M, Azarine A, Azizi M; DENERHTN Investigators. Abdominal Aortic Calcifications Influences the Systemic and Renal Hemodynamic Response to Renal Denervation in the DENERHTN (Renal Denervation for Hypertension) Trial. J Am Heart Assoc. 2017 Oct 10;6(10):e007062. doi: 10.1161/JAHA.117.007062.

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central;pdfs.semanticscholar.org

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

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

ReferenceCitation: Gosse P, Cremer A, Pereira H, Bobrie G, Chatellier G, Chamontin B, Courand PY, Delsart P, Denolle T, Dourmap C, Ferrari E, Girerd X, Michel Halimi J, Herpin D, Lantelme P, Monge M, Mounier-Vehier C, Mourad JJ, Ormezzano O, Ribstein J, Rossignol P, Sapoval M, Vaisse B, Zannad F, Azizi M. Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):494-500. doi: 10.1161/HYPERTENSIONAHA.116.08448. Epub 2017 Jan 23.

ReferenceCitation: Azizi M, Pereira H, Hamdidouche I, Gosse P, Monge M, Bobrie G, Delsart P, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Girerd X, Michel Halimi J, Zannad F, Ormezzano O, Vaisse B, Herpin D, Ribstein J, Chamontin B, Mourad JJ, Ferrari E, Plouin PF, Jullien V, Sapoval M, Chatellier G; DENERHTN Investigators. Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. Circulation. 2016 Sep 20;134(12):847-57. doi: 10.1161/CIRCULATIONAHA.116.022922. Epub 2016 Aug 30.

ReferenceCitation: Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; Renal Denervation for Hypertension (DENERHTN) investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323. No abstract available.


title: Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy

acronym: TOLEDO

summary:
Ever since the biotherapy agents have entered the market, the recommended therapeutic objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to their tolerance in the medium and long term as well as their high price. Nevertheless, we do not dispose considerable data on the risks of relapse or structural progression during such a step down strategy. A few studies on anti-TNF agents have shown the possibility of such therapy reduction. A national study, " STRASS ", coordinated by Bruno FAUTREL, has evaluated the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data concerning Abatacept or Tocilizumab has been published.

As the expected result, this study is aimed to test the feasibility of a step down strategy on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.

ipd_sharing: Undecided


title: Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

acronym: MECCORT

summary:
Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis.

In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended.

The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.


title: Phenotypical Approach of the Drug Metabolizing Hormones Activity (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp) Before and After Roux-en Y-Gastric Bypass. The SODA Protocol: Surgery for Obesity and Drug Availability

acronym: SODA

summary:
The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric Bypass.

Primary aim : To study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.

location_facility: Unit of internal medicine A, Lariboisière Hospital


title: Survey of Patients With Idiopathic Orbital Inflammation Syndrome (IOIS): Clinical, Morphological and Pathological Features and Treatment Outcomes

acronym: SIOI

summary: The purpose of this study is to characterise the clinical features, histopathology and the treatment outcomes of patients with idiopathic orbital inflammation syndrome.

time_perspective: Other

location_facility: Service de Médecine interne - Hôpital Avicenne


title: Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II.

acronym: OCCLURANDOM

summary: This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators:
National Cancer Institute, France
Advanced Accelerator Applications


title: A Phase I/II, Open-label, Multicentre, Dose Escalation Study Assessing Safety/Tolerability of pEYS606 When Administered by Electrotransfer (ET) in Ciliary Muscle of Patients With Non-infectious Posterior, Intermediate or Panuveitis

summary:
Primary objective: safety and tolerability

Secondary objectives: additional indicators of long term safety and indicators of clinical activity

Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers

ReferenceCitation: Touchard E, Benard R, Bigot K, Laffitte JD, Buggage R, Bordet T, Behar-Cohen F. Non-viral ocular gene therapy, pEYS606, for the treatment of non-infectious uveitis: Preclinical evaluation of the medicinal product. J Control Release. 2018 Sep 10;285:244-251. doi: 10.1016/j.jconrel.2018.07.013. Epub 2018 Aug 1.

lead_sponsor: Eyevensys

location_country:
United Kingdom
France

location_facility:
Moorfields Eye Hospital
CHU de Grenoble - Hôpital Michallon
Bristol Eye Hospital
Hôpital Cochin

intervention_type: Biological


title: Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients

acronym: CIRCAME

summary: The CIRCAME study is a bicenter study of patients from 2 memory clinics in Paris. The main objective is to identify circadian rhythm components and other individual risk factors (sociodemographic, behavioral, and health related factors) associated with the diagnosis of subtypes (AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive impairment, clinical dementia) of dementia, independent of known risk factors (sociodemographic and genetic) and assess the relevance of use of these factors in primary care for screen of dementia including subtypes and stages. A secondary objective is to determine factors associated with progression of the disease, in terms of cognitive decline and limitations in activities of daily living, as well as progression to dementia among cognitively healthy controls and patients with mild cognitive impairment, up to 15 years after the inclusion period.

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

location_facility: Hôpital de Jour Gériatrique et consultation mémoire


title: Contribution of a Multimodal Digital Platform in the Management and Follow-up of Patients With Amyotrophic Lateral Sclerosis Treated With Non-invasive Ventilation: Randomized Controlled Study

acronym: ANEX

summary: The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.

lead_sponsor: University Hospital, Montpellier

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

location_facility:
Clinique du Millénaire
Uh Montpellier


title: Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic

acronym: ANGIOCOR

summary: This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.

location_facility:
Hôpital européen Georges-Pompidou AP-HP
Hôpital Cochin - AP-HP


title: Quality of Life and Addiction Among Hospital Night Workers - Descriptive Study of APHP Workers in Paris

acronym: ALADDIN

summary:
The current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. In addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. The more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. Increasing the use of psychoactive substances (SPAs) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. This self-medication behaviour is not without risks, neither for staff nor for patients.

The ALADDIN study is a project made up of 2 waves of questionnaires - one during and the other after the Covid "hospital" crisis - filled in by the hospital night staff of AP-HP. This project will assess the impact of the Covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff.

The main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the AP-HP and to describe the participants' quality of working life.

Methods The study is prospective study using an online self-completed questionnaire. The questionnaire was elaborated on the basis of the validated scales ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test), AUDIT-C (Alcohol Use Disorder Test, shortened version) and HAD (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift.

The questionnaire will be completed at t0 (baseline) and 18 months after. This study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. It will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.

lead_sponsor: University Paris 7 - Denis Diderot

location_facility: Assistance Publique des Hopitaux de Paris


title: Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

acronym: iTEPsein

summary:
Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.

Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;

lead_sponsor: Nantes University Hospital

location_facility:
Hospital
Institut de Cancérologie de l'Ouest


title: Evaluation of Anthropological, Socio-cultural and Psychological Factors of Surgeons Practising in Oncology Which Condition Brakes in the Evaluation of Surgical Innovations

acronym: SURGprofil

summary: The field of surgery continues to benefit from innovative solutions, changing surgical methods and techniques. Evaluation in terms of efficacy and Quality-Safety is an essential topic that directly affects the introduction of innovations. It is essential to carry out a robust evaluation strategy for surgical innovations, even if these are often opposed to drug innovations. The aim of this study is to investigate the anthropological, socio-cultural and psychological differences of surgeons that influence the evaluation of surgical innovations.

ReferenceCitation: Bories P, Lamy S, Simand C, Bertoli S, Delpierre C, Malak S, Fornecker L, Moreau S, Recher C, Nebout A. Physician uncertainty aversion impacts medical decision making for older patients with acute myeloid leukemia: results of a national survey. Haematologica. 2018 Dec;103(12):2040-2048. doi: 10.3324/haematol.2018.192468. Epub 2018 Jul 13.

ReferenceCitation: Brandberg Y, Malm M, Blomqvist L. A prospective and randomized study, "SVEA," comparing effects of three methods for delayed breast reconstruction on quality of life, patient-defined problem areas of life, and cosmetic result. Plast Reconstr Surg. 2000 Jan;105(1):66-74; discussion 75-6. doi: 10.1097/00006534-200001000-00011.

ReferenceCitation: Castel P, Negrier S, Boissel JP; Plateforme d'Aide a la Recherche Clinique en Cancerologie de la region Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer. 2006 Aug;42(12):1744-8. doi: 10.1016/j.ejca.2005.10.033. Epub 2006 Jun 14.

ReferenceCitation: Concato J, Peduzzi P, Holford TR, Feinstein AR. Importance of events per independent variable in proportional hazards analysis. I. Background, goals, and general strategy. J Clin Epidemiol. 1995 Dec;48(12):1495-501. doi: 10.1016/0895-4356(95)00510-2.

ReferenceCitation: Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.

ReferenceCitation: Crocker JC, Farrar N, Cook JA, Treweek S, Woolfall K, Chant A, Bostock J, Locock L, Rees S, Olszowski S, Bulbulia R. Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff. BJS Open. 2020 Oct 4;4(6):1238-45. doi: 10.1002/bjs5.50345. Online ahead of print.

ReferenceCitation: Cros F, Lamy S, Grosclaude P, Nebout A, Chabrillac E, Vergez S, Bories P, Dupret-Bories A. Physician practice variation in head and neck cancer therapy: Results of a national survey. Oral Oncol. 2021 Jun;117:105293. doi: 10.1016/j.oraloncology.2021.105293. Epub 2021 Apr 14.

ReferenceCitation: Elliott D, Hamdy FC, Leslie TA, Rosario D, Dudderidge T, Hindley R, Emberton M, Brewster S, Sooriakumaran P, Catto JWF, Emara A, Ahmed H, Whybrow P, le Conte S, Donovan JL. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int. 2018 Dec;122(6):970-977. doi: 10.1111/bju.14432. Epub 2018 Aug 15.

ReferenceCitation: Evrard S, McKelvie-Sebileau P, van de Velde C, Nordlinger B, Poston G. What can we learn from oncology surgical trials? Nat Rev Clin Oncol. 2016 Jan;13(1):55-62. doi: 10.1038/nrclinonc.2015.176. Epub 2015 Oct 20.

ReferenceCitation: Filleron T, Bonnetain F, Mancini J, Martinez A, Roche H, Dalenc F. Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study. Contemp Clin Trials. 2015 Jan;40:1-8. doi: 10.1016/j.cct.2014.11.005. Epub 2014 Nov 8.

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

ReferenceCitation: Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, Deutsch M, Schwarz G, Margolese R, Donegan W, Volk H, Konvolinka C, Gardner B, Cohn I Jr, Lesnick G, Cruz AB, Lawrence W, Nealon T, Butcher H, Lawton R. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer. 1977 Jun;39(6 Suppl):2827-39. doi: 10.1002/1097-0142(197706)39:63.0.co;2-i. No abstract available.

ReferenceCitation: Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. Clinicians' attitudes towards clinical trials of cancer therapy. Br J Cancer. 2011 May 10;104(10):1535-43. doi: 10.1038/bjc.2011.119. Epub 2011 Apr 12.

ReferenceCitation: Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.

ReferenceCitation: Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.

ReferenceCitation: Goyal A, Mann GB, Fallowfield L, Duley L, Reed M, Dodwell D, Coleman RE, Fakis A, Newcombe R, Jenkins V, Whitham D, Childs M, Whynes D, Keeley V, Ellis I, Fairbrother P, Sadiq S, Monson K, Montgomery A, Tan W, Vale L, Homer T, Badger H, Haines RH, Lewis M, Megias D, Nabi Z, Singh P, Caraman A, Miles E; POSNOC Trialists. POSNOC-POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy: a randomised controlled trial of axillary treatment in women with early-stage breast cancer who have metastases in one or two sentinel nodes. BMJ Open. 2021 Dec 2;11(12):e054365. doi: 10.1136/bmjopen-2021-054365.

ReferenceCitation: Gray S, Price C. Barriers to participation in randomised controlled trials. J Clin Epidemiol. 2001 Mar;54(3):323-4. doi: 10.1016/s0895-4356(00)00279-1. No abstract available.

ReferenceCitation: Halsted WS. I. A Clinical and Histological Study of certain Adenocarcinomata of the Breast: and a Brief Consideration of the Supraclavicular Operation and of the Results of Operations for Cancer of the Breast from 1889 to 1898 at the Johns Hopkins Hospital. Ann Surg. 1898 Nov;28(5):557-76. No abstract available.

ReferenceCitation: Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research and innovation?: the IDEAL framework for action. Int J Surg. 2013;11(10):1038-42. doi: 10.1016/j.ijsu.2013.09.016. Epub 2013 Oct 7. No abstract available.

ReferenceCitation: Jones RP, Are C, Hugh TJ, Grunhagen DJ, Xu J, Balch CM, Poston GJ. Reshaping the critical role of surgeons in oncology research. Nat Rev Clin Oncol. 2019 May;16(5):327-332. doi: 10.1038/s41571-018-0149-1.

ReferenceCitation: McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.

ReferenceCitation: McLeod RS. Issues in surgical randomized controlled trials. World J Surg. 1999 Dec;23(12):1210-4. doi: 10.1007/s002689900649.

ReferenceCitation: Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR, Singh H, Ibrahim A, DeClaro RA, Shen Y, Tang S, Sridhara R, Kluetz PG, Concato J, Pazdur R, Beaver JA. External control arms in oncology: current use and future directions. Ann Oncol. 2022 Apr;33(4):376-383. doi: 10.1016/j.annonc.2021.12.015. Epub 2022 Jan 10.

ReferenceCitation: Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698.

ReferenceCitation: Nakamura S. Axillary lymph node dissection in sentinel node positive breast cancer: is it necessary? Curr Opin Obstet Gynecol. 2013 Feb 19. doi: 10.1097/GCO.0b013e32834f3608. Online ahead of print.

ReferenceCitation: Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study. Trials. 2014 Mar 14;15:80. doi: 10.1186/1745-6215-15-80.

ReferenceCitation: Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999 Dec;52(12):1143-56. doi: 10.1016/s0895-4356(99)00141-9.

ReferenceCitation: Schroen AT, Brenin DR. Breast cancer treatment beliefs and influences among surgeons in areas of scientific uncertainty. Am J Surg. 2010 Apr;199(4):491-9. doi: 10.1016/j.amjsurg.2009.04.005.

ReferenceCitation: Spillane AJ, Mann GB. Surgeon knows best versus breast cancer surgical clinical trial equipoise: a plea for the sake of future trials. ANZ J Surg. 2017 Mar;87(3):111-112. doi: 10.1111/ans.13831. No abstract available.

ReferenceCitation: Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med. 1984 May 24;310(21):1363-7. doi: 10.1056/NEJM198405243102106.

ReferenceCitation: Tibau A, Molto C, Borrell M, Del Paggio JC, Barnadas A, Booth CM, Amir E. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials. JAMA Oncol. 2018 Nov 1;4(11):1610-1611. doi: 10.1001/jamaoncol.2018.4300.

ReferenceCitation: Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Guo H, Hudis CA, Krop IE, Burstein HJ, Winer EP. Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer. N Engl J Med. 2015 Jan 8;372(2):134-41. doi: 10.1056/NEJMoa1406281. Erratum In: N Engl J Med. 2015 Nov 12;373(20):1989.

ReferenceCitation: Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. "When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
West Cancerology Institute, France
Toulouse Capitole University


title: A 24-week, Multicenter, Randomized, Double Blind, Placebo-controlled, Dose-range Finding Phase II Study to Compare Efficacy and Safety of Oral Masitinib to Placebo in Treatment of Patients With Severe Mast Cell Activation Syndrome (MCAS) With Handicap Unresponsive to Optimal Symptomatic Treatment

summary: To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.

ReferenceCitation: Lortholary O, Chandesris MO, Bulai Livideanu C, Paul C, Guillet G, Jassem E, Niedoszytko M, Barete S, Verstovsek S, Grattan C, Damaj G, Canioni D, Fraitag S, Lhermitte L, Georgin Lavialle S, Frenzel L, Afrin LB, Hanssens K, Agopian J, Gaillard R, Kinet JP, Auclair C, Mansfield C, Moussy A, Dubreuil P, Hermine O. Masitinib for treatment of severely symptomatic indolent systemic mastocytosis: a randomised, placebo-controlled, phase 3 study. Lancet. 2017 Feb 11;389(10069):612-620. doi: 10.1016/S0140-6736(16)31403-9. Epub 2017 Jan 7.

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

version: acceptedVersion

repository_institution: OSF Preprints - OSF Preprints

repositories:
HAL
PubMed Central
share.osf.io

repositories_concat: HAL;PubMed Central;share.osf.io

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

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

publisher_dissemination: American Chemical Society

ipd_sharing_description: No Masitinib is under clinical investigation and has not yet been approved in any sought-after indication by any health authority worldwide. As such, there is no plan for data-sharing at this point in time.

lead_sponsor: AB Science

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Necker-Enfants Malades Hospital, Centre de référence des Mastocytoses (CEREMAST)


title: Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections

acronym: CATH-GE

summary: Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.

lead_sponsor: Institut Pasteur

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

acronym: PHAM

summary: Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.

ReferenceCitation: Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. doi: 10.1056/NEJMoa022831.

ReferenceCitation: Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.

collaborators: Laboratoire français de Fractionnement et de Biotechnologies

acronyme: PHAM

titre: Prévention des hémorragies sous assistance circulatoire mécanique

discipline_principale: cardiologie

nom_porteur: SUSEN

prenom_porteur: Sophie


title: Prospective Multicentre Study Assessing the Feasibility of Enhanced Recovery After Sleeve Gastrectomy for Obesity

acronym: SLEEVERAS

summary: The primary purpose of the study is to test the feasibility of a protocol of enhanced recovery after surgery for reducing the total length of hospital stay in a large scale setting

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Direction Générale de l'Offre de Soins
Ministry of Health, France

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: SLEEVERAS

titre: Etude prospective observationnelle sur la faisabilité d'un protocole de réhabilitation rapide après gastrectomie longitudinale pour obésité

discipline_principale: mpr

nom_porteur: SLIM

prenom_porteur: Karem


title: Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study

acronym: ARREVE

summary: The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.

ReferenceCitation: Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22. Erratum In: Intensive Care Med. 2017 Nov 24;:

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier, Service de réanimation

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

acronyme: ARREVE

titre: ARREt progressif de la VEntilation mécanique ou extubation chez les patients de réanimation en fin de vie : épidémiologie et ressenti des proches et des soignants.

nom_porteur: ROBERT

prenom_porteur: René


acronym: Adjuvant Pegylated Interferon in Ulcerated Melanoma

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

summary:
Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.

The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: CHU de Nice - CHU de Nice - Hopital De L'Archet

location_facility: Mid Essex Hospitals - Broomfield Hospital

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: St Helens and Knowsley Teaching Hospitals

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: I.P.O. Francisco Gentil - Centro De Lisboa

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elisabeth Medical Centre

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

location_facility: Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Avicenne

location_facility: IRCCS - Istituto Tumori "Giovanni Paolo II"

title: Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Spain
France


title: Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?

acronym: EXP DIAL

summary: This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.

sponsor_collaborators:
University Hospital, Montpellier
AIDER- Santé
Avignon University (EA4278 - LaPEC)
Pr Philippe OBERT
Dr Claire MAUFRAIS

location_facility: Lapeyronie Hospital clinical trials Department