title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study: Predictable Results and Experience in Diabetes Through Intensification and Control to Target: an International Variability Evaluation

acronym: PREDICTIVE™

summary:
This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.

ReferenceType: result

ReferenceCitation: Dornhorst A, Lüddeke HJ, Honka M, Ackermann RW, Meriläinen M, Gallwitz B, Sreenan S; PREDICTIVE Study Group. Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study. Curr Med Res Opin. 2008 Feb;24(2):369-76.

ReferenceCitation: Honka M. [Results of the PREDICTIVE project in the Czech Republic]. Vnitr Lek. 2008 Apr;54(4):361-7. Czech.

ReferenceCitation: Dornhorst A, Lüddeke HJ, Koenen C, Meriläinen M, King A, Robinson A, Sreenan S; PREDICTIVE Study Group. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE. Diabetes Obes Metab. 2008 Jan;10(1):75-81. Epub 2007 Nov 22.

ReferenceCitation: Dornhorst A, Lüddeke HJ, Sreenan S, Koenen C, Hansen JB, Tsur A, Landstedt-Hallin L. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract. 2007 Mar;61(3):523-8.

ReferenceCitation: Dornhorst A, Lüddeke HJ, Sreenan S, Kozlovski P, Hansen JB, Looij BJ, Meneghini L; PREDICTIVE Study Group. Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008 Apr;62(4):659-65. doi: 10.1111/j.1742-1241.2008.01715.x.

family: Dornhorst

full_name: A. Dornhorst

given: A.

family: Lüddeke

full_name: H.-J. Lüddeke

family: Sreenan

full_name: S. Sreenan

given: S.

family: Kozlovski

full_name: P. Kozlovski

given: P.

family: Hansen

full_name: J. B. Hansen

given: J. B.

family: Looij

full_name: B.-J. Looij

family: Meneghini

full_name: L. Meneghini

given: L.

journal_name: International Journal of Clinical Practice

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVETM study

ReferenceCitation: Lüddeke HJ, Sreenan S, Aczel S, Maxeiner S, Yenigun M, Kozlovski P, Gydesen H, Dornhorst A; PREDICTIVE Study Group. PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab. 2007 May;9(3):428-34.

ReferenceCitation: Sreenan S, Virkamäki A, Zhang K, Hansen JB; PREDICTIVE study group. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study. Int J Clin Pract. 2008 Dec;62(12):1971-80. doi: 10.1111/j.1742-1241.2008.01939.x. Erratum in: Int J Clin Pract. 2009 Jan;63(1):176-7:178-80.

family: Virkamäki

full_name: A. Virkamäki

family: Zhang

full_name: K. Zhang

given: K.

name: on behalf of the PREDICTIVE™ study group

title: Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE™ study

ReferenceCitation: Palmer JL, Goodall G, Nielsen S, Kotchie RW, Valentine WJ, Palmer AJ, Roze S. Cost-effectiveness of insulin aspart versus human soluble insulin in type 2 diabetes in four European countries: subgroup analyses from the PREDICTIVE study. Curr Med Res Opin. 2008 May;24(5):1417-28. doi: 10.1185/030079908X297295 . Epub 2008 Apr 8.

name:
IMS Health
BaselSwitzerland

family: Palmer

full_name: James L. Palmer

given: James L.

family: Goodall

full_name: Gordon Goodall

given: Gordon

name:
Novo Nordisk
BagsværdDenmark

family: Nielsen

full_name: Steffen Nielsen

given: Steffen

name:
IMS Health
LondonUK

family: Kotchie

full_name: Robert W. Kotchie

given: Robert W.

family: Valentine

full_name: William J. Valentine

given: William J.

ReferenceCitation: Valentine WJ, Goodall G, Aagren M, Nielsen S, Palmer AJ, Erny-Albrecht K. Evaluating the cost-effectiveness of therapy conversion to insulin detemir in patients with type 2 diabetes in Germany: a modelling study of long-term clinical and cost outcomes. Adv Ther. 2008 Jun;25(6):567-84. doi: 10.1007/s12325-008-0069-z.

ReferenceCitation: Hermansen K, Lund P, Clemmensen K, Breum L, Kleis Moller M, Mette Rosenfalck A, Christiansen E; Danish PREDICTIVE study group. 3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study. Rev Diabet Stud. 2007 Summer;4(2):89-97. Epub 2007 Aug 10.

ReferenceCitation: Fontaine P, Gin H, Pinget M, Thivolet C, Hanaire H, Robert JJ, Marre M, Venkatanarasimhachar S. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther. 2009 May;26(5):535-51. doi: 10.1007/s12325-009-0033-6. Epub 2009 Jun 2.

ReferenceCitation: Hermansen K, Dornhorst A, Sreenan S. Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal-bolus regimens: insights from the PREDICTIVE study. Curr Med Res Opin. 2009 Nov;25(11):2601-8. doi: 10.1185/03007990903262885.

name: Department of Endocrinology and Metabolism, Aarhus University Hospital, Denmark

name: Department of Metabolic Medicine, Imperial College, London, UK

name: Department of Endocrinology, Connolly Hospital, Dublin, Ireland

title: Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal–bolus regimens: insights from the PREDICTIVE study

ReferenceCitation: Niskanen L, Virkamäki A, Hansen JB, Saukkonen T. Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: evidence from the PREDICTIVE study. Diabetes Res Clin Pract. 2009 Nov;86(2):e15-8. doi: 10.1016/j.diabres.2009.08.005. Epub 2009 Sep 10.

title: Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: Evidence from the PREDICTIVE™ study

ReferenceCitation: Yenigun M, Honka M. Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE study. Int J Clin Pract. 2009 Mar;63(3):425-32. doi: 10.1111/j.1742-1241.2008.01973.x.

title: Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE™ study

ReferenceCitation: Perriello G, Caputo S, De Pergola G, Di Carlo A, Grassi G, Lapolla A, Pata P, Solerte SB, Zaccardi F. Improved glycemic control with weight loss and a low risk of hypoglycemia with insulin detemir: insights from the Italian cohort of the PREDICTIVE study after 6-month observation in type 2 diabetic subjects. Expert Opin Pharmacother. 2011 Nov;12(16):2449-55. doi: 10.1517/14656566.2011.626766. Erratum in: Expert Opin Pharmacother. 2011 Dec;12(17):2765.

ReferenceCitation: Yang L, Christensen T, Sun F, Chang J. Cost-effectiveness of switching patients with type 2 diabetes from insulin glargine to insulin detemir in Chinese setting: a health economic model based on the PREDICTIVE study. Value Health. 2012 Jan-Feb;15(1 Suppl):S56-9. doi: 10.1016/j.jval.2011.11.018.

title: Cost-Effectiveness of Switching Patients with Type 2 Diabetes from Insulin Glargine to Insulin Detemir in Chinese Setting: A Health Economic Model Based on the PREDICTIVE Study

ReferenceCitation: Sreenan S, Andersen M, Thorsted BL, Wolden ML, Evans M. Increased Risk of Severe Hypoglycemic Events with Increasing Frequency of Non-severe Hypoglycemic Events in Patients with Type 1 and Type 2 Diabetes. Diabetes Ther. 2014 Dec;5(2):447-58. doi: 10.1007/s13300-014-0075-x. Epub 2014 Jul 15.

location_country:
Italy
Sweden
United Kingdom
Finland
France
Greece
Israel
Ireland
Belgium
Turkey
Denmark
Czech Republic
Korea, Republic of


type: Other Identifier

title: European Registry of Patients With Infantile-onset Spinal Muscular Atrophy

summary: IO-SMA-Registry is a prospective, longitudinal and observational study which objective is to collect prospectively information on longevity, psychomotor development and respiratory function of patients with infantile-onset spinal muscular atrophy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Institut de Myologie, France

location_facility: Maladie Neuromusculaire de l'enfant - Service Maladies infectieuses et neurologie infantile - Hôpital Roger Salengro

location_facility: Unité de neurologie pédiatrique - Hôpital des enfants

location_facility: Service de Rééducation Pédiatrique Infantile " L'Escale " - Hôpital Femme Mère Enfant

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Grant/Funding Number

title: Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution

summary: The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Lactalis

intervention_type: Dietary Supplement


title: Constitution of a National Cohort of Patients With Metastatic Melanoma Stage IV or Unresectable Stage III With the Objective of Setting up a Epidemiological Monitoring and a Clinico-biological Database, MELBASE

acronym: MelBase

summary:
Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011 with anti-CTLA4, programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene, serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological studies aiming to validate and identify new prognostic and predictive factors based upon clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules prospective collection of economic data on treatment and toxicity are required. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects.

MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose objectives are :

To provide an annual instrument panel with a descriptive and correlative analysis of patients with advanced melanoma in France including epidemiological, clinical and biological socio-economic characteristics
to validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma.
to evaluate the risk-benefit, the impact on treatment on patient quality of life, the management cost of patients treated with the validated and future treatments of metastatic melanoma. The project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile.

Patients with unresectable stage III or stage IV melanoma will be enrolled prospectively for 1 year with a 5 years follow-up (a total of 2000 patients will be enrolled) from 26 French centers A database of clinical monitoring of metastatic patients will be established and associated with a virtual tumor bank. This national database will be issued from the use of biological, clinical and imaging databases already available in the centers and optimized for this project; this database will also results from the interaction with the French national cancer institute (INCa) genotyping platform.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers

summary: The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5.

ReferenceCitation: Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903.

ReferenceType: derived

ReferenceCitation: de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppé E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentré F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.

family: de Gunzburg

full_name: Jean de Gunzburg

given: Jean

sequence: first

name: Metagenopolis, Institut National de la Recherche Agronomique, Jouy-en-Josas, France

family: Ghozlane

full_name: Amine Ghozlane

given: Amine

sequence: additional

family: Ducher

full_name: Annie Ducher

given: Annie

family: Le Chatelier

full_name: Emmanuelle Le Chatelier

given: Emmanuelle

name: Bichat Claude Bernard Hospital, University Paris Diderot, Sorbonne Paris Cité, Paris

name: Institut National de la Santé et de la Recherche Médicale, Infection Antimicrobials Modelling Evolution, Unité Mixte de Recherche, France

family: Duval

full_name: Xavier Duval

given: Xavier

family: Ruppé

full_name: Etienne Ruppé

given: Etienne

family: Armand-Lefevre

full_name: Laurence Armand-Lefevre

given: Laurence

family: Sablier-Gallis

full_name: Frédérique Sablier-Gallis

given: Frédérique

family: Burdet

full_name: Charles Burdet

given: Charles

family: Alavoine

full_name: Loubna Alavoine

given: Loubna

name: Institut Gustave-Roussy, Villejuif, France

family: Chachaty

full_name: Elisabeth Chachaty

given: Elisabeth

family: Augustin

full_name: Violaine Augustin

given: Violaine

family: Varastet

full_name: Marina Varastet

given: Marina

family: Levenez

full_name: Florence Levenez

given: Florence

family: Kennedy

full_name: Sean Kennedy

given: Sean

family: Pons

full_name: Nicolas Pons

given: Nicolas

family: Mentré

full_name: France Mentré

given: France

family: Andremont

full_name: Antoine Andremont

given: Antoine

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Infectious Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

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

location_facility: CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard


title: Facilitate and Sustain Return to Work After Breast Cancer: Randomized Controlled Trial

acronym: FASTRACS-RCT

summary:
Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol.

The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer.

Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category.

The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process.

The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools).

Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.

status: Recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Hopital de la croix rousse, Hospices Civils de Lyon

location_facility: Hopital Lyon sud, Hospices civils de Lyon

location_facility: Hopital femme mère enfant, Hospices Civils de Lyon

intervention_type: Behavioral

status_simplified: Ongoing


acronym: CAPARFI

summary:
Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening.

For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C).

The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Bordeaux - Hôpital Saint André
CHU de Bordeaux - Hôpital Haut-Lévêque

intervention_type: Device


title: Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services

acronym: RESTO DATA

summary:
The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.

A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).

The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).

time_perspective: Cross-Sectional

location_facility: APHP, Hopital Henri Mondor, Service de Médecine Bucco-Dentaire

location_facility: CHRU de Brest, Service Odontologie consultation spécialisée

location_facility: APHP Hôpital Charles Foix, Service Odontologie consultation spécialisée

location_facility: CHU de Reims, Pôle de Médecine Bucco-Dentaire

location_facility: CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire

location_facility: Hospices Civils de Lyon, Service d'Odontologie


title: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

acronym: PERCEPTION

summary:
This is a national, non interventional, prospective study performed in the general practice setting.

The study has been designed :

to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.

lead_sponsor: AstraZeneca


title: External Anal Sphincter Fatigability, an Electromyographic and Manometric Study

acronym: EASF

summary:
External anal sphincter is a Skeletal muscle under voluntary control. As described in previous studies, it is mainly composed of type 1 fibers. Fatigability is a concept which has been studied and described many times in skeletal limbs muscles. Two types of fatigue are described, peripheral of central fatigue. Fatigue can been physiologic but also pathologic (due to an affection of the muscle, the peripheral nervous system or the central nervous system). Many tools have been used to measure muscle fatigability (direct strength measure on isometric contraction, electromyography, echography, oxymetry...).

Besides many fatiguing methods have been developed for every each muscle depending on its histological structure.

Anal sphincter fatigability has already been described in few manometric studies with particularly 2 measures: Fatigue Rate and Fatigue Rate Index. Moreover, no fatiguing protocol has been standardized to study it.

The primary aim of this study is to define a fatiguing protocol for external anal sphincter in order to study it in further studies. Secondary aims are to assess Electromyography as a tool for measuring this fatigability and finally to assess the link between anal sphincter fatigability and symptoms reported by patients.

Patients over 18 years old, consulting for an Anorectal Manometry with a voluntary command on the external anal sphincter are included.

History and treatment, height, weight, sex, age, Fatigue impact scale, digestive symptoms with Neurologic Bowel Disorders score and Wexner scale, urinary tract symptoms with Urinary Symptom Profile (USP) score and electromyography (Root Mean Square (RMS) and Mean Power Frequency (MPF)) and manometric data (contraction peak, fatigue rate, fatigue rate index) were recorded.

The fatiguing protocol consists in 10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting. A training contraction is made before the fatiguing protocol. At the end of the protocol, patients undergo a classical anorectal manometry.

Primary outcome is the difference on root mean square in electromyography between the first and the last fatiguing contraction.

Secondary outcomes were mean power frequency and manometric data (i.e. Fatigue Rate index (FRI), Fatigue Rate (FR), contraction Peak)

Influence of age, sex, symptoms, pathologies, weight on fatigability will be studied in a second analysis

lead_sponsor: Gérard Amarenco

location_facility: department of Neuro-Urology, Hôpital Tenon


title: Weaker Chest Compression After Nightshift : The We CAN Study.

acronym: WeCAN

summary: The investigators sought to evaluate the influence of fatigue after a night shift on the quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.

lead_sponsor: Bistro Study Group

location_facility: Hôpital Pitié-Salpêtrière; Hopital Saint Antoine; Hopital Tenon


type: Registry Identifier

title: Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation

summary: The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.

status: Terminated

primary_purpose: Treatment

ReferenceCitation: Dieckmann D, Plottner H, Berchtold S, Berger T, Schuler G. Ex vivo isolation and characterization of CD4(+)CD25(+) T cells with regulatory properties from human blood. J Exp Med. 2001 Jun 4;193(11):1303-10.

ReferenceCitation: Goguel AF, Crainic K, Ducailar A, Ouin M. Interlaboratory quality assessment of lymphocyte phenotyping. Etalonorme 1990-1992 surveys. Biol Cell. 1993;78(1-2):79-84.

ReferenceCitation: Holmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9.

ReferenceCitation: Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31.

ReferenceCitation: Joao C, Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Markovic SN. Early lymphocyte recovery after autologous stem cell transplantation predicts superior survival in mantle-cell lymphoma. Bone Marrow Transplant. 2006 May;37(9):865-71.

ReferenceCitation: Jonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94.

ReferenceCitation: Noether, G. E. Sample size determination for some common nonparametric statistics. Journal of the American Statistical Association 82 : 645-47, 1987.

ReferenceCitation: Peggs KS. Immune reconstitution following stem cell transplantation. Leuk Lymphoma. 2004 Jun;45(6):1093-101. Review.

ReferenceCitation: Porrata LF, Gertz MA, Inwards DJ, Litzow MR, Lacy MQ, Tefferi A, Gastineau DA, Dispenzieri A, Ansell SM, Micallef IN, Geyer SM, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous hematopoietic stem cell transplantation in multiple myeloma or non-Hodgkin lymphoma. Blood. 2001 Aug 1;98(3):579-85.

ReferenceCitation: Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Litzow MR, Winters JL, Markovic SN. Early lymphocyte recovery predicts superior survival after autologous stem cell transplantation in non-Hodgkin lymphoma: a prospective study. Biol Blood Marrow Transplant. 2008 Jul;14(7):807-16. doi: 10.1016/j.bbmt.2008.04.013.

ReferenceCitation: Porrata LF, Inwards DJ, Micallef IN, Ansell SM, Geyer SM, Markovic SN. Early lymphocyte recovery post-autologous haematopoietic stem cell transplantation is associated with better survival in Hodgkin's disease. Br J Haematol. 2002 Jun;117(3):629-33.

ReferenceCitation: Reimer P, Kunzmann V, Wilhelm M, Weissbrich B, Kraemer D, Berghammer H, Weissinger F. Cellular and humoral immune reconstitution after autologous peripheral blood stem cell transplantation (PBSCT). Ann Hematol. 2003 May;82(5):263-70. Epub 2003 Mar 22.

ReferenceCitation: Roberts MM, To LB, Gillis D, Mundy J, Rawling C, Ng K, Juttner CA. Immune reconstitution following peripheral blood stem cell transplantation, autologous bone marrow transplantation and allogeneic bone marrow transplantation. Bone Marrow Transplant. 1993 Nov;12(5):469-75.

ReferenceCitation: Sebban, C., Lefranc, A, Perrier, L., Morreau, P., Espinouse, D., Moles-Moreau, M-P, Kammoun, L, Ghesquieres, H, Segura-Ferlay, C., Bay, J-O, Lissandre, S, PEROL, D, Michallet, M, and Quittet, P. A Randomized Phase II Study Evaluating the Efficacy, Safety and Cost-Effectiveness of Pegfilgrastim and Filgrastim After High Dose Chemotherapy and Autologous Stem Cell Transplantation In Patients with Lymphoma and Myeloma (PALM Study). ASH . 4-12-2010. Ref Type: Abstract

ReferenceCitation: Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.

ReferenceCitation: Singh RK, Ino K, Varney ML, Heimann DG, Talmadge JE. Immunoregulatory cytokines in bone marrow and peripheral blood stem cell products. Bone Marrow Transplant. 1999 Jan;23(1):53-62.

ReferenceCitation: Talmadge JE, Reed E, Ino K, Kessinger A, Kuszynski C, Heimann D, Varney M, Jackson J, Vose JM, Bierman PJ. Rapid immunologic reconstitution following transplantation with mobilized peripheral blood stem cells as compared to bone marrow. Bone Marrow Transplant. 1997 Jan;19(2):161-72.

ReferenceCitation: Thornton AM, Shevach EM. Suppressor effector function of CD4+CD25+ immunoregulatory T cells is antigen nonspecific. J Immunol. 2000 Jan 1;164(1):183-90.

ReferenceCitation: Vanstraelen G, Frère P, Ngirabacu MC, Willems E, Fillet G, Beguin Y. Pegfilgrastim compared with Filgrastim after autologous hematopoietic peripheral blood stem cell transplantation. Exp Hematol. 2006 Mar;34(3):382-8.

ReferenceCitation: Woo EY, Chu CS, Goletz TJ, Schlienger K, Yeh H, Coukos G, Rubin SC, Kaiser LR, June CH. Regulatory CD4(+)CD25(+) T cells in tumors from patients with early-stage non-small cell lung cancer and late-stage ovarian cancer. Cancer Res. 2001 Jun 15;61(12):4766-72.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
CHU Clermont-Ferrand, Hôpital d'Estaing

intervention_type: Drug


title: Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

acronym: CTR

summary:
The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin.

The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.

ReferenceCitation: Chase HP, Doyle FJ 3rd, Zisser H, Renard E, Nimri R, Cobelli C, Buckingham BA, Maahs DM, Anderson S, Magni L, Lum J, Calhoun P, Kollman C, Beck RW; Control to Range Study Group. Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes. Diabetes Technol Ther. 2014 Oct;16(10):623-32. doi: 10.1089/dia.2014.0050. Epub 2014 Sep 4.

name: Barbara Davis Center for Childhood, Aurora, Colorado.

family: Chase

full_name: H. Peter Chase

given: H. Peter

name: Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, California.

family: Doyle

full_name: Francis J. Doyle

given: Francis J.

suffix: III

name: Sansum Diabetes Research Institute, Santa Barbara, California.

family: Zisser

full_name: Howard Zisser

given: Howard

name: Montpellier University Hospital, Department of Endocrinology, Diabetes, Nutrition and INSERM 1001 Clinical Investigation Center, the Institute of Functional Genomics, UMR CNRS 5203/INSERM U661, University of Montpellier, France.

family: Renard

full_name: Eric Renard

given: Eric

name: Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel and Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.

family: Nimri

full_name: Revital Nimri

given: Revital

family: Cobelli

full_name: Claudio Cobelli

given: Claudio

name: Stanford University, Stanford, California.

family: Buckingham

full_name: Bruce A. Buckingham

given: Bruce A.

family: Maahs

full_name: David M. Maahs

given: David M.

name: University of Virginia, Charlottesville, Virginia.

family: Anderson

full_name: Stacey Anderson

given: Stacey

family: Magni

full_name: Lalo Magni

given: Lalo

name: Jaeb Center for Health Research, Tampa, Florida.

family: Lum

full_name: John Lum

given: John

family: Calhoun

full_name: Peter Calhoun

given: Peter

family: Kollman

full_name: Craig Kollman

given: Craig

family: Beck

full_name: Roy W. Beck

given: Roy W.

journal_name: Diabetes Technology & Therapeutics

oa_host_type: repository

license_normalized: no license

evidence: oa repository (via pmcid lookup)

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Multicenter Closed-Loop/Hybrid Meal Bolus Insulin Delivery with Type 1 Diabetes

ReferenceCitation: Zisser H, Renard E, Kovatchev B, Cobelli C, Avogaro A, Nimri R, Magni L, Buckingham BA, Chase HP, Doyle FJ 3rd, Lum J, Calhoun P, Kollman C, Dassau E, Farret A, Place J, Breton M, Anderson SM, Dalla Man C, Del Favero S, Bruttomesso D, Filippi A, Scotton R, Phillip M, Atlas E, Muller I, Miller S, Toffanin C, Raimondo DM, De Nicolao G, Beck RW; Control to Range Study Group. Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites. Diabetes Technol Ther. 2014 Oct;16(10):613-22. doi: 10.1089/dia.2014.0066. Epub 2014 Jul 8. Erratum in: Diabetes Technol Ther. 2015 Jan;17(1):68. Vistenin, Roberto [corrected to Visentin, Roberto].

name: Montpellier University Hospital, Department of Endocrinology, Diabetes, Nutrition and INSERM 1411 Clinical Investigation Center, Institute of Functional Genomics, UMR CNRS 5203/INSERM U661, University of Montpellier, Montpellier, France.

family: Kovatchev

full_name: Boris Kovatchev

given: Boris

name: Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.

name: Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.

title: Multicenter Closed-Loop Insulin Delivery Study Points to Challenges for Keeping Blood Glucose in a Safe Range by a Control Algorithm in Adults and Adolescents with Type 1 Diabetes from Various Sites

location_facility: University of Colorado Health Sciences Center- Barbara Davis


acronym: MAPAGE

summary:
High blood pressure (HBP) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. Reducing blood pressure (BP) significantly decreases cardiovascular morbi-mortality. Nevertheless, BP control remains insufficient: only 51% of French patients using antihypertensive drugs achieve the BP control targets.

HBP is mostly diagnosed and managed in primary care. Nevertheless, office BP measurements are unreliable for BP control and poorer predict target organ damage. Ambulatory BP measurements are recommended for HBP diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (ABPM) is the most cost-effective strategy. Its superiority has been demonstrated for HBP diagnosis and cardiovascular prognosis.

In France, ABPM is poorly available and little studied in primary care. Therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of ABPM among primary care hypertensive patients in daily practice.

lead_sponsor: University of Burgundy

location_facility: Maison Universitaire de Santé et de Soins Primaires

location_facility: Groupement des Professionnels de Santé de l'Auxois Sud

location_facility: Groupements des Professionnels de Santé du Pays Beaunois


title: Identification of Plasmatic Biomarkers in Vascular Ehlers-Danlos Syndrome

acronym: MEDIC

summary: The purpose of this study is to determine whether patients with vascular Ehlers-Danlos syndrome present significant and specific changes of arterial endothelial and smooth muscular cell signalling/secretion, in comparison to matched healthy volunteers and patients with spontaneous arterial dissections.

ReferenceCitation: Morissette R, Schoenhoff F, Xu Z, Shilane DA, Griswold BF, Chen W, Yang J, Zhu J, Fert-Bober J, Sloper L, Lehman J, Commins N, Van Eyk JE, McDonnell NB. Transforming growth factor-β and inflammation in vascular (type IV) Ehlers-Danlos syndrome. Circ Cardiovasc Genet. 2014 Feb;7(1):80-8. doi: 10.1161/CIRCGENETICS.113.000280. Epub 2014 Jan 6.


title: Remission Induction Therapy for Refractory Systemic Lupus Erythematosus With Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Versus Rituximab (antiCD20) Followed by Maintenance Therapy With Mycophenolate Mofetil (MMF)

acronym: ASTIL

summary: The purpose of this study is to evaluate remission induction therapy for refractory Lupus Erythematosus with autologous hematopoietic stem cell transplantation (AHSCT) versus Rituximab (anti CD20) followed by maintenance therapy with mycophenolate mofetil (MMF).

status: Withdrawn

lead_sponsor: European Society for Blood and Marrow Transplantation

location_facility: Dept. of Internal Medicine, Hôpital Saint-Louis


title: Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

summary:
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.

The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.

lead_sponsor: Notal Vision Ltd.

location_facility: Centre Hospitalier Intercommunal de Creteil


title: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer

acronym: REBECCA

summary: The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

lead_sponsor: Sophie JACOB


title: Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

acronym: ERNU

summary: This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier d'arrondissement de Montreuil sur mer

location_facility: Centre Hospitalier intercommunal Eure-Seine

location_facility: Centre Hospitalier intercommunal d'Elbeuf-Louvier


title: Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings

summary:
Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland.

These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness.

Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy.

One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included.

Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.

Main objective: To compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.

ReferenceCitation: Rouvière O, Puech P, Renard-Penna R, Claudon M, Roy C, Mège-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.

family: Rouvière

full_name: Olivier Rouvière

given: Olivier

family: Puech

full_name: Philippe Puech

given: Philippe

family: Renard-Penna

full_name: Raphaële Renard-Penna

given: Raphaële

family: Claudon

full_name: Michel Claudon

given: Michel

family: Roy

full_name: Catherine Roy

given: Catherine

family: Mège-Lechevallier

full_name: Florence Mège-Lechevallier

given: Florence

family: Decaussin-Petrucci

full_name: Myriam Decaussin-Petrucci

given: Myriam

family: Dubreuil-Chambardel

full_name: Marine Dubreuil-Chambardel

given: Marine

family: Magaud

full_name: Laurent Magaud

given: Laurent

family: Remontet

full_name: Laurent Remontet

family: Ruffion

full_name: Alain Ruffion

given: Alain

family: Colombel

full_name: Marc Colombel

given: Marc

family: Crouzet

full_name: Sébastien Crouzet

given: Sébastien

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Lemaitre

full_name: Laurent Lemaitre

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Grenier

full_name: Nicolas Grenier

given: Nicolas

family: Barry Delongchamps

full_name: Nicolas Barry Delongchamps

family: Boutier

full_name: Romain Boutier

given: Romain

family: Bratan

full_name: Flavie Bratan

given: Flavie

family: Brunelle

full_name: Serge Brunelle

given: Serge

family: Camparo

full_name: Philippe Camparo

family: Colin

full_name: Pierre Colin

given: Pierre

family: Corréas

full_name: Jean-Michel Corréas

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

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

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - CHU de Toulouse

location_facility: CLIMAL (Centre Libéral Imagerie Médicale Agglomération Lille)

location_facility: Groupe Hospitalier Pellegrin - CHU de Bordeaux

location_facility: Nouvel Hopital Civil - CHU de Strasbourg


title: A French Prospective, Observational Cohort Study of Patients With Fabry Disease Treated With Migalastat - the MIGA-FAB Study

summary: This is a cohort study to evaluate the effects of migalastat, on long-term safety, effectiveness, and quality of life (QOL) in patients with Fabry disease.

lead_sponsor: Amicus Therapeutics France SAS

location_facility: CHU de Grenoble site Nord, Hôpital Albert Michallon


title: Treatment-related Benefit and Satisfaction in Fabry Patients. Insight in Patients Expectations and Preferences (SATIS-Fab)

summary:
In the shared decision-making process, patients should express their expectations and preferences regarding treatment to the physician. A specific questionnaire addressing needs and expectations of Fabry patients has been built at the initiative of Amicus. In addition, this questionnaire also evaluates the benefit of treatment from the patient's perspective. Nothing is known until now on patient's expectations, potential clustering of patients regarding their expectations and evaluation of treatment benefit from the patients perspective.

Study objectives are differentiated according to the study phase (inclusion and follow-up). At inclusion, the primary objective is to cluster patients according to their needs and expectations regarding treatment. During follow-up, the primary objective is to evaluate treatment benefit in relation with patients needs and expectations.

location_facility: Centre de référence de la maladie de Fabry et des maladies héréditaires du tissu conjonctif

location_facility: Groupe hospitalier Diaconesses Croix Saint-Simon


title: A Psoriasis Plaque Test Study With LEO 90100 Cutaneous Spray, Ointment, in Psoriasis Vulgaris

summary: The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

ReferenceCitation: Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015 Apr;35(4):239-45. doi: 10.1007/s40261-015-0269-7.

family: Queille-Roussel

full_name: Catherine Queille-Roussel

family: Olesen

full_name: Martin Olesen

given: Martin

family: Villumsen

full_name: John Villumsen

given: John

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

journal_name: Clinical Drug Investigation

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Efficacy of an Innovative Aerosol Foam Formulation of Fixed Combination Calcipotriol plus Betamethasone Dipropionate in Patients with Psoriasis Vulgaris

ReferenceCitation: Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Semin Cutan Med Surg. 2015;34 S1:PA-10.

ReferenceCitation: Hollesen Basse L, Olesen M, Lacour J, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33(abst 192).

lead_sponsor: LEO Pharma

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)


title: Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

acronym: SSS

summary: The purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality

ReferenceCitation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77.

ReferenceCitation: Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311.

ReferenceCitation: Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.

ReferenceCitation: Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. Epub 2007 Dec 4. Erratum in: Intensive Care Med. 2008 Apr;34(4):783-5.

ReferenceCitation: Sebat F, Johnson D, Musthafa AA, Watnik M, Moore S, Henry K, Saari M. A multidisciplinary community hospital program for early and rapid resuscitation of shock in nontrauma patients. Chest. 2005 May;127(5):1729-43.

location_facility: Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital


title: Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70: Phase II Multicentre Study

acronym: LPP

summary:
Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis. Plasma cell leukaemia is defined as: at least 2,000 circulating plasma cells per µL for a blood leukocyte count higher than 10,000/µL or 20% of plasma cells for a leukocyte count less than 10,000/µL. Plasma cell leukaemia can be either primary, when it constitutes the first manifestation of the disease, or secondary in the setting of relapsed/refractory multiple myeloma. Primary plasma cell leukaemia (PPL) is a rare disease, representing only 1 to 2% of all cases of multiple myelomas at diagnosis. As the annual incidence of multiple myeloma in France is about 4,000 new cases, an estimated 40 to 80 new cases of PPL would be observed each year.

Few data are currently available in the literature concerning the pathophysiology and therapeutic management of PPL, and are derived from retrospective series based small numbers of patients. The prognosis of PPL in response to conventional chemotherapy remains poor with a median survival of 7 to 14 months. However, longer survivals have been obtained with intensive therapy and haematopoietic stem cell transplantation (allogeneic or autologous HSCT).

The investigators propose to perform a prospective study of the management of patients with PPL under the age of 70 years, in combination with a laboratory study: 12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles. Peripheral blood stem cell collection after mobilization by G-CSF will be performed after high-dose Cyclophosphamide chemotherapy. Autologous HSCT conditioned by high-dose Melphalan will be performed during the following month for all responding patients. During the 3 months after this first autologous HSCT, allogeneic HSCT with attenuated conditioning will be proposed in patients under the age of 66 years in complete remission with a suitable donor, and another systematic autologous HSCT will be proposed in all other patients. For all patients not treated by allogeneic HSCT, consolidation/maintenance therapy will be performed 3 months after the second autologous HSCT: 4 quarterly consolidations with Bortezomib-Lenalidomide-Dexamethasone (VRD) with maintenance by 2 months of Lenalidomide between these cycles, for a total duration of one year.

The laboratory assessment will consist of blood and bone marrow samples systematically obtained at diagnosis for plasma cell phenotyping by cytometry, cytogenetics, FISH, study of the gene expression profile and SNParray. A DNA bank and plasma bank will be constituted. The investigators also propose to study residual disease by cytometry (after the first autologous HSCT, before and at the end of the consolidation/maintenance phase), as it increasingly appears to have a major impact on survival in multiple myeloma.

location_facility:
CH Pays d'Aix
CHRU Lille
Hospices Civils de Lyon
CHU Strasbourg
CH Dunkerque
CHU Toulouse
CHU Clermont Ferrand
CHU Poitiers
AP-HP
CHU Caen
CHU Tours
CHU Besançon
CHU Dijon
CHU Nantes
CHU Nancy
CHU Nice
CHU Rennes
CHU Amiens


title: A Comparative, Dose-Escalating, Placebo-Controlled Study of the Efficacy and Safety of PAZ320, Ingested Together With a Standard Meal on Post-Prandial Glucose and Insulin Blood Levels in Type II Diabetic Patients Treated With Metformin

summary: The purpose of this study is to test the efficacy of PAZ320 in diabetic patients.

lead_sponsor: Boston Therapeutics

location_facility: Department of Internal Medicine, Infectious Diseases and Diabetology Hopital Robert Bisson (Lisieux)


title: Evaluation of Lung Clearance Index for Early Detection of Lung Disease in Young Children With Cystic Fibrosis

acronym: LCI

summary:
The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible.

Moreover this screening procedure permits to note the improvement following the treatment and to choose the optimal treatment in term of efficacy.

primary_purpose: Screening


acronym: AntiTNF-SN

type: EudraCT Number

source: euctr

title: Phase II Clinical Trial Using Humira in Netherton Syndrome

summary:
The main objective of this studies therapeutic : to determine the effect of Adalimumab (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome after 3 months of treatment , with a post treatment period follow-up of 3 months.

Second objectives are To evaluate the safety of Adalimumab in the context of NS To evaluate the improvement of the quality of life at 3 months To evaluate the improvement of pruritus and pain in the patients To study markers of inflammatory and allergy in NS prior and after treatment Benefit of the study An improvement by at least 20% of the cutaneous signs in these patients who suffer from a genetic incurable, chronic, painful and very afflicting disease would be of a great help for these patients. NS is a major source of social exclusion.

Risks They are inherent to the risks of biotherapies, especially for an anti-TNF therapy, they comprise a risk of infection. Cutaneous infections occur mainly during infancy, and we have therefore chosen to treat patients over 4 years of age in this study.

A close clinical surveillance will be set up (initially every week during the first month of treatment, then every month). This will represents a large number of visits but will provide a high level of security.

Benefits/risks ratio In the absence of curative treatment for these patients with a severe genetic skin disease, the benefits/risks ration clearly appears to be in favour of an expected benefit.


title: A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial

acronym: PCD

summary:
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy.

Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment.

In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it.

This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization.

This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial.

In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance.

This study will contain 3 treatment phases:

Study treatment phase:

All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination.

Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial):

For patients previously randomized in IFM/DFCI 2009's arm A:

Melphalan 200 mg/m2 followed by Autologous Transplantation
Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination

For patients previously randomized in IFM/DFCI 2009's arm B:

5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination
Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason.

For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient.

In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm.

The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria.

ReferenceCitation: Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

name: Proliferation and Differentiation of Stem Cells, INSERM, Unité Mixte de Recherche (UMR)_S 938, Paris, France;

name: Département d'Hématologie et de Thérapie Cellulaire, Assistance Publique des Hôpitaux de Paris, Hôpital Saint Antoine, Paris, France;

family: Garderet

full_name: Laurent Garderet

family: Kuhnowski

full_name: Frederique Kuhnowski

given: Frederique

family: Berge

full_name: Benoit Berge

given: Benoit

name: Centre Hospitalier Universitaire, Institut Universitaire du Cancer de Toulouse–Oncopole, Toulouse, France;

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Centre Hospitalier Universitaire, Rennes, France;

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

name: Centre Hospitalier Universitaire, Dijon, France;

family: Lafon

full_name: Ingrid Lafon

given: Ingrid

name: Maladies du Sang, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire Lille, Lille, France;

family: Facon

full_name: Thierry Facon

given: Thierry

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Hospices Civils de Lyon, Pierre Benite Cedex, France;

family: Karlin

full_name: Lionel Karlin

given: Lionel

name: Centre Hospitalier Universitaire, Vandoeuvre Les Nancy, France;

family: Perrot

full_name: Aurore Perrot

given: Aurore

name: Centre Hospitalier Universitaire Hôtel Dieu, Nantes, France;

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Centre Hospitalier Universitaire, Bordeaux, France;

family: Marit

full_name: Gerald Marit

given: Gerald

name: Department of Hematology, Institut Paoli Calmettes, Marseille, France;

family: Stoppa

full_name: Anne-Marie Stoppa

name: Centre Hospitalier Universitaire, Amiens, France;

family: Royer

full_name: Bruno Royer

given: Bruno

name: Centre Hospitalier Universitaire, Clermont Ferrand, France;

family: Chaleteix

full_name: Carine Chaleteix

given: Carine

name: Hopital de La Roche sur Yon, La Roche sur Yon, France;

family: Tiab

full_name: Mourad Tiab

given: Mourad

name: Centre Hospitalier de la Côte Basque, Bayonne, France;

family: Araujo

full_name: Carla Araujo

given: Carla

family: Lenain

full_name: Pascal Lenain

given: Pascal

name: Centre Hospitalier Universitaire, Caen, France;

family: Macro

full_name: Margaret Macro

given: Margaret

name: Centre Hospitalier de Le Mans, Le Mans, France;

family: Voog

full_name: Eric Voog

given: Eric

name: Centre Hospitalier Universitaire, Hôpital Bretonneau, Tours, France;

family: Benboubker

full_name: Lofti Benboubker

given: Lofti

name: Centre Hospitalier de Saint Brieuc, Saint Brieuc, France;

family: Allangba

full_name: Olivier Allangba

given: Olivier

name: Centre Hospitalier Universitaire, Nîmes, France;

family: Jourdan

full_name: Eric Jourdan

name: Centre Hospitalier de la région d’Annecy, Pringy, France;

name: Centre Hospitalier Universitaire Henri Mondor, Créteil, France;

name: Centre Hospitalier Général, Dunkerque, France;

name: Centre Hospitalier Régional et Universitaire, Grenoble, France;

name: Centre Hospitalier Universitaire, Limoges, France;

name: Hôpital René Huguenin, Saint Cloud, France; and

location_facility: Centre Hospitalier départemental de Vendée

location_facility: Institut Universitaire du Cancer Toulouse-Oncopôle (IUCT-O)

location_facility: Institut d'Hématologie de Basse Normandie - IHBN


title: Influence of Sodium Intake on Left Ventricular-arterial Coupling in Hypertension: Biomechanical Assessment and Modelisation of Left Ventricular Function With Arterial Pressure

summary: The objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.

lead_sponsor: University Hospital, Montpellier

location_facility: Lapeyronie University Hospital of Montpellier


title: Assessment of βeta Blocker Interruption After Uncomplicated mYocardial Infarction on Safety and Symptomatic Cardiac Events Requiring Hospitalization: The AβYSS Study

acronym: AβYSS

summary: ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons.

ipd_sharing_description: There is not a plan to make IPD available

location_facility: Institut de Cardiologie - USIC - Hôpital Pitié-Salpêtrière


title: Efficacy of IntraVenous ImmunoGlobulins (IVIG) in Toxic Shock Syndromes (Staphylococcal and Streptococcal): a Paediatric Pilot Study.

acronym: IVIG

summary:
Staphylococcus aureus and Streptococcus pyogenes produce many virulence factors. Some of them are responsible for severe infections in humans. Superantigen toxins synthesized by S. aureus or by S. pyogenes, are responsible for toxic shock syndromes (TSS) which lethality can attain 25% in children with validated criteria of septic shock.

Previous studies, performed in vitro and in vivo in animals, have shown that Intravenous immunoglobulins [IVIG] contain antibodies [Ab] against these toxins and, when used at high concentration, IVIG are able to neutralize their toxicity. However, in all these studies, IVIG administration has been preventive and there is no reliable data demonstrating their therapeutic efficacy in vitro or in vivo in humans or in animals, once the disease is present.

The efficacy of IVIG is established in other pathologies for which the role of the superantigens [superAg] is suspected, like Kawasaki disease in children. The mechanism of action, although not perfectly known, involves at the same time a direct effect on superAg (Ag-Ab complex) and indirect effects like the neutralisation of superAg within the network of anti-idiotype Ab or the neutralisation of the T-cells receptors. Staphylococcal and streptococcal toxic shocks imply bacterial exotoxins that are superAg. It seems thus consistent to imagine a same type of treatment with IVIG. However, there is currently no evidence of the efficacy of IVIG in this indication. One of the explanations relies on the lack of statistical power of previous adult studies, which principal objective was to show a reduction of the mortality. Taking into account the low prevalence of TSS, it has been hard to recruit enough patients to have the required statistical power. Moreover, some works have been extracted from larger studies on septic shock and the definitions of the TSS were nor always very reliable. Lastly, if the investigators consider the definition of the TSS as mentioned by the " Centre for Disease Control " [CDC], for which any hypotension, even a simple orthostatic hypotension, serves the diagnosis of TSS as long as the other symptoms are present, it is obvious that many patients are likely to be recruited in a study although it is highly probable that their health will get better with a " standard " treatment. The definition of a " real " TSS can be refined, keeping the CDC criteria, but changing the hypotension criterion in a more accurate criterion as described in the " surviving sepsis campaign ", internationally accepted and based on norms adapted to the age for paediatric forms.

IVIG therapy is very expensive and TSS is not recognized as indication of IVIG according to their marketing authorization. The feasibility of a randomized controlled study with this treatment needs to be assessed as it would be hazardous to conduct a large prospective RCT without having first assessed this feasibility in terms of recruitment rates, consent rates or compliance rates. Inclusion, randomisation and collect of inform consent in the context of severe shock are challenging and require evaluation of feasibility. The sample size calculation of the large study on mortality required estimations of the event in the specific population of children with criteria of septic shock. Surrogates markers of outcome need to be better defined. For example it would be useful to determine the evolution of organ dysfunctions with and without IVIG treatment in this population.

Various organ failure scores, used upon admission and later on, have been validated in adults and in children. The absence of improvement of the Paediatric logistic organ dysfunction (Pelod) score over time is a good indicator of mortality in Paediatric intensive care unit (PICU). It could be used as surrogate marker to evaluate the efficacy of IVIG.

primary_purpose: Other


title: Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers

acronym: PASSION

summary:
A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).

The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.

The second aim is to assess the satisfaction of patients and health care teams.

ipd_sharing: Yes


title: Community and Hospital Experiences for Patients Treated by Oral Chemotherapy at the University Hospital of Caen: Analysis of the Process and Its Dysfunctions

acronym: PARCOURS

summary:
PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months).

References used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients.

Parameters found are : information exchanged, ambulatory and hospital monitoring in case of adverse event and adherence to treatment. The study includes also a medico-economic evaluation (hospitalization and transport spending in case of dysfunction in the patient's journey). Deviations will be analyzed.

lead_sponsor: University Hospital, Caen


title: Comprehensive Analysis of Regional Myocardial Function in Response to Dobutamine Stress in Metabolic Syndrome and Type 2 Diabetic Patients. Effect of Cardiac Adiposity, Inflammation and Hyperglycaemia

summary:
Summary.

Theoretical Rationale:

The left ventricular myocardial performance results from a complex interplay between linear deformations (longitudinal, circumferential and radial) and twist/ untwist mechanics. These components of myocardial mechanics can be assessed, at rest and during stress conditions, by high resolution echocardiography using the "2D-strain" technology and constitute good indexes of tissue intrinsic contractility / relaxation properties. Type 2 diabetes (T2DM) and metabolic syndrome (MS) are associated with an increased risk for cardiac diseases. While several clinical studies have reported, particularly in T2DM, a diastolic dysfunction (concept of "diabetic cardiomyopathy"), the existence of impaired regional myocardial function, with altered intrinsic contractility properties, remains largely unanswered, especially in the SM. Stress echocardiography is very interesting to reveal myocardial dysfunction, discrete or absent at rest. To the best of our knowledge, no scientific study is, however, today available on the kinetics of linear strains and twist/untwist dynamics in response to stress in T2DM as well as SM. The epicardial adipose tissue is the source of production of important pro-inflammatory cytokines that have the potential, through an exacerbation of oxidative stress, to impair coronary endothelial function, increase fibrosis, but also directly affect cardiomyocyte calcium homeostasis. An increase in epicardial adipose tissue is consensually reported in T2DM and SM and is clearly associated with coronary atherosclerosis. A link between cardiac adiposity and overall cardiac function, particularly diastolic, is now suggested but to our knowledge no study has challenged its association with myocardial dysfunction in T2DM as SM patients.

Objectives and Methodology: - To investigate regional myocardial linear deformations and torsion, at rest and in response to a dobutamine stress, in asymptomatic T2DM and SM patients without clinical complications, - to study the links between expected regional myocardial abnormalities and inflammation, hyperglycemia and cardiac adiposity. A control group of healthy individuals matched for sex and age will also be included.

All the subjects will benefit from a clinical, anthropometric and biological evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic functions) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the objective assessment of myocardial longitudinal deformations as well as in the parasternal short axis (base and apex) for the evaluation of the circumferential deformations and basal and apical rotations and left ventricular torsion, at rest and under low dose of dobutamine (110 and 120 bpm).

lead_sponsor: University of Avignon


title: The Ketogenic Diet for Alzheimer's Disease: a Randomized Controlled Feasibility Study.

acronym: CETOMA

summary:
The ketogenic diet (KD) is a metabolic shift, which stimulates the liver oxidation of fatty acids to produce ketone bodies. These ketone bodies represent an alternative fuel source for the brain. The benefits of KD in epilepsia have been demonstrated for decades. This diet may also provide benefits in Alzheimer's disease (AD) where neuronal glucose utilization declines from the early stage. Besides, the KD could decrease neuroinflammation, oxidative stress and enhance mitochondrial biogenesis. In murin models of AD, KD or Medium Chain Triglycerides consumption were associated with lower neuroinflammation but also with a diminution of neuropathologic features of AD (amyloid and tau lesions in the brain). Moreover, behavioural effets and improvements in memory and motor function have been highlighted. In humans, recent studies suggest cognitive benefits (memory, executive function) in AD, including in the Mild Cognitive Impairment (MCI) stage. The feasibility and the adherence to the diet proved to be correct, in small samples, in particular in MCI individuals over a short follow-up period (3 to 6 months).

This study aims at examining the feasibility of a KD followed-up for one year in participants with early AD (N=70). Change in brain metabolism will be assessed using PET scan after 12 months, comparing KD with control diet. The effects on cognition, quality of life and daily living functioning will be analysed. The safety, nutritional changes and adhesion to the diet will be monitored throughout the study.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP)


title: Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study

summary:
Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation.

The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.


title: Nonverbal Communication in Aged People With and Without Neurodegenerative Disease: Study of Sensorimotor Synchronization to Music

acronym: MAMUS

summary: Musical interventions improve the emotional state of patients with Alzheimer's disease (AD) while having a positive impact on the caregiver's well-being. However, the factors that could be responsible for this positive effect remain unknown. Among these, the sensory-motor synchronization (SMS) of movements to the musical rhythm, frequently observed during musical activities and possible up to the advanced stages of AD, could modulate the emotional state. Several recent studies have shown that rhythmic training (or SMS) influences the organism at the motor, cognitive and social levels while activating the cerebral reward circuit. This action that generates pleasure also facilitates non-verbal emotional expression. However, the conditions that modulate SMS and their relationship to nonverbal communication, emotional, behavioral and cognitive state have not yet been studied in healthy or pathological elderly.

lead_sponsor: University Hospital, Lille


title: Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry

summary: This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

time_perspective: Other

ReferenceCitation: Charbonneau P, Kölbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22.

family: Charbonneau

full_name: Philippe Charbonneau

family: Kölbel

full_name: Tilo Kölbel

given: Tilo

family: Rohlffs

full_name: Fiona Rohlffs

given: Fiona

family: Eilenberg

full_name: Wolf Eilenberg

given: Wolf

family: Planche

full_name: Olivier Planche

family: Bechstein

full_name: Matthias Bechstein

given: Matthias

family: Ristl

full_name: Robin Ristl

given: Robin

family: Greenhalgh

full_name: Roger Greenhalgh

given: Roger

family: Haulon

full_name: Stephan Haulon

given: Stephan

journal_name: European Journal of Vascular and Endovascular Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Medical University of Vienna

location_country: Germany France

location_facility: Marie Lannelongue Hospital (Paris, France)

location_facility: University Hospital Hamburg-Eppendorf (Hamburg, Germany)


title: Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

summary: Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.

lead_sponsor: Decathlon SE

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Assessment of the Safety and Performance of a Patellofemoral Brace

summary: Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.


title: Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice

summary: Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


title: A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours

summary: The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.


title: A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

summary: The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière


title: Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach

acronym: COELIOCHIP

summary: The peritoneum is the second most common site of recurrence in patients with colorectal cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. The most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet


title: Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies

acronym: BIG-RENAPE

summary:
To access to good quality biological samples is a prerequisite for high level translational research. The BIG-RENAPE study has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies.

The main BIG-RENAPE study aim is to create a large multicentric and prospective repository for biological and tissue samples, which will provide a source of materials for a wide array of health related research studies - BIG-RENAPE Biobank-based research: i) validating known and promising biomarkers; ii) identifying new predictive and prognostic factors; iii) evaluating the impact of current health care strategies; iv) standardizing diagnostic and therapeutic management through guidelines; v) developing new drugs.

The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing, storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of diagnostic and therapeutic care. The patient and his derivates are anonymized and registered in a national web database reporting disease status, treatments, surgical procedures, pathological diagnosis, quality of life's assessment and long term follow-up. All participants have given their informed consent before any sample. The BIG-RENAPE study was approved by the local Ethical Committee, based on the assessed compliance to French regulatory rules.

ReferenceCitation: Bonnefoy I, Mohamed F, Bonnot PE, Benzerdjeb N, Isaac S, Cotte E, Glehen O, Passot G. Risk of Omental Metastases in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases. Dis Colon Rectum. 2020 Sep;63(9):1251-1256. doi: 10.1097/DCR.0000000000001670.

family: Bonnefoy

full_name: Isabelle Bonnefoy

given: Isabelle

family: Mohamed

full_name: Faheez Mohamed

given: Faheez

family: Bonnot

full_name: Pierre-Emmanuel Bonnot

given: Pierre-Emmanuel

family: Benzerdjeb

full_name: Nazim Benzerdjeb

given: Nazim

family: Isaac

full_name: Sylvie Isaac

given: Sylvie

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Glehen

full_name: Olivier Glehen

family: Passot

full_name: Guillaume Passot

given: Guillaume

journal_name: Diseases of the Colon & Rectum

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Péron J, Mercier F, Tuech JJ, Younan R, Sideris L, Gelli M, Dumont F, Le Roy B, Sgarbura O, Lo Dico R, Bibeau F, Glehen O, Passot G; on behalf BIG-RENAPE working groups. The location of the primary colon cancer has no impact on outcomes in patients undergoing cytoreductive surgery for peritoneal metastasis. Surgery. 2019 Feb;165(2):476-484. doi: 10.1016/j.surg.2018.07.027. Epub 2018 Sep 7.

family: Péron

full_name: Julien Péron

given: Julien

family: Mercier

full_name: Frederic Mercier

given: Frederic

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Younan

full_name: Rami Younan

given: Rami

family: Sideris

full_name: Lucas Sideris

given: Lucas

family: Gelli

full_name: Maximiliano Gelli

given: Maximiliano

family: Dumont

full_name: Frederic Dumont

family: Le Roy

full_name: Bertrand Le Roy

given: Bertrand

family: Sgarbura

full_name: Olivia Sgarbura

given: Olivia

family: Lo Dico

full_name: Rea Lo Dico

given: Rea

family: Bibeau

full_name: Frederic Bibeau

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


title: Experience of Relatives and Caregivers of Death in ICU After the Withdrawal of Life-sustaining Therapies, Associated With an Organ Procurement Procedure (Controlled Donation After Circulatory Death).

summary:
Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.

Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD. Better understanding their perceptions and experiences will enable to develop interventions to support and guide them throughout this practice.

location_facility: APHP - Lariboisière hospital - réanimation chirurgicale


title: Study of Intra-monocytic Imiglucerase Kinetic and Its Correlation With Clinical and Biological Gaucher Disease

acronym: CIMI

summary:
Rational: Imiglucerase has been used to treat Gaucher disease since 1997 but data about its pharmacokinetics have been partial; investigators know that imiglucerase undergoes a quick clearance from plasma compartment following the infusion (1/2 life: 1-6 min, from tissue: <24h), an observation apparently contradictory with usual infusion rhythm (one infusion every two weeks). Furthermore, by going by GD response, the rhythm of Infusion is sometimes diminished (for example, every 3 or 4 wks) without pharmacological rational ; In parallel, investigators demonstrated that monocytes represent a satisfactory surrogate of GD target cells and that enzyme activity into monocytes varies between individuals.

Our hypothesis is that enzyme activity into monocyte compartment could be different and could be related to GD response.

Primary purpose: to evaluate the pharmacokinetics of Imiglucerase activity into target cellular compartment depending on dose and frequency of infusions.

Secondary purposes : 1) to establish a possible relationship between the intra-monocytic activity of glucocerebrosidase and the clinical and biological activity of Gaucher disease and to define a possible threshold value of enzyme activity; 2) to establish a better correlation with known biomarkers of disease (routine markers and markers recently identified), which would better predict and / or monitor response to treatment ; 3) to compare the residual and natural rate of activity enzyme intra-monocytic for untreated patients (low severity disease).

lead_sponsor: University Hospital, Clermont-Ferrand


title: Fluid Intake During Labour, Ultrasound Evaluation

acronym: EGTO

summary: We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.

ReferenceCitation: Rousset J, Clariot S, Tounou F, Burey J, Hafiani EM, Féliot E, Quesnel C, Bonnet F, Fischler M. Oral fluid intake during the first stage of labour: A randomised trial. Eur J Anaesthesiol. 2020 Sep;37(9):810-817. doi: 10.1097/EJA.0000000000001278.

family: Rousset

full_name: Julien Rousset

family: Clariot

full_name: Simon Clariot

given: Simon

family: Tounou

full_name: Félix Tounou

given: Félix

family: Burey

full_name: Julien Burey

family: Hafiani

full_name: El M. Hafiani

given: El M.

family: Féliot

full_name: Elodie Féliot

given: Elodie

family: Quesnel

full_name: Christophe Quesnel

given: Christophe

family: Bonnet

full_name: Francis Bonnet

given: Francis

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: European Journal of Anaesthesiology

lead_sponsor: Hopital Foch

location_facility:
Tenon
Hopital Foch
CHI Andre Gregoire