title: Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology to Improve Stress and Quality of Life With Joint Participation of "Witness / Patient / Caregivers"

acronym: IMPLIC

summary: The study is based on the realization of a meditation program associating patients, caregivers and control subjects

ReferenceCitation: Prevost V, Clarisse B, Leconte A, Delorme C, Benoit S, Tran T. Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness. BMJ Open. 2021 Nov 12;11(11):e048164. doi: 10.1136/bmjopen-2020-048164.

family: Prevost

full_name: V Prevost

given: V

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Leconte

full_name: Alexandra Leconte

given: Alexandra

family: Delorme

full_name: Claire Delorme

given: Claire

family: Benoit

full_name: Sandrine Benoit

given: Sandrine

family: Tran

full_name: Titi Tran

given: Titi

lead_sponsor: Centre Francois Baclesse


acronym: ACABII

summary:
Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large arteries, mainly carotid, is involved in about 20% of cases.

After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography.

The composition of the plaque, showing its vulnerability, is associated with embolic risk and stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo the inflammation of the plaque, its embolic consequences or the mechanical stress it undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile (mi RNA). These different modalities must be combined in order to increase the efficiency.

Based on these encouraging results, the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability. Performance evaluation will allow us to choose secondarily the most relevant association.

The investigator propose, as a first step, to make a case-control study with these methods, the cases are patients who had an ischemic stroke (authenticated by both the clinical exam and brain MRI) on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke. This study is a cross-sectional study because it simultaneously measures the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque.

Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50% caliber constriction according to NASCET criteria. (North American Symptomatic Carotid Endarterectomy Trial).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Service de radiologie

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.

acronym: NEWS

summary:
When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction.

Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life).

The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales.

Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente

status_simplified: Completed


type: EudraCT Number

title: A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)

summary:
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).

The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Debiopharm International SA

location_facility:
Institut Claudius Regaud
Institut Curie
Centre Léon Bérard
Centre Georges François Leclerc

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceType: derived

ReferenceCitation: Léger J, Fjellestad-Paulsen A, Bargiacchi A, Pages J, Chevenne D, Alison M, Alberti C, Guilmin-Crepon S. One Year of GH Treatment for Growth Failure in Children With Anorexia Nervosa: A Randomized Placebo-Controlled Trial. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2535-e2546. doi: 10.1210/clinem/dgab203.

name: Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Endocrinology-Diabetology Department, Reference Center for Growth and Development Endocrine Diseases, Paris, France

name: Université de Paris; NeuroDiderot, Institut National de la Santé et de la Recherche Médicale (INSERM) UMR 1141, Paris, France

family: Léger

full_name: Juliane Léger

given: Juliane

sequence: first

family: Fjellestad-Paulsen

full_name: Anne Fjellestad-Paulsen

given: Anne

sequence: additional

name: Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Child and Adolescent Psychiatry Department, Reference Center for Growth and Development Endocrine Diseases, Paris, France

family: Bargiacchi

full_name: Anne Bargiacchi

name: Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Clinical Epidemiology Unit, Paris, France

family: Pages

full_name: Justine Pages

given: Justine

name: Assistance Publique-Hôpitaux de Paris, Biochemistry Unit, Robert Debré University Hospital, Paris, France

family: Chevenne

full_name: Didier Chevenne

given: Didier

name: Assistance Publique-Hôpitaux de Paris, Robert Debré University Hospital, Pediatric Radiology Department, Paris, France

family: Alison

full_name: Marianne Alison

given: Marianne

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Guilmin-Crepon

full_name: Sophie Guilmin-Crepon

given: Sophie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

design_allocation: Randomized

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: OREX

source: euctr

title: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone

summary: Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. However, despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients have a significant short stature with reduced adult final height and a deficit of bone mass. The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth velocity in prepubertal children or children in early puberty with anorexia nervosa and significant reduction of height velocity. This is a single-center, controlled, randomized and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in total 2 years of study for each child. This second period corresponds to an ethical consideration giving secondarily access to treatment for patients in the placebo group.


title: Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization: Prospective Study With Virological Follow-up on 24 Months (SUIVICOL)

acronym: SUIVICOL

summary: CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Toulouse, Hôpital Paule de Viguier

intervention_type: Other


title: The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas

acronym: BCB-Sarcomes

summary:
The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas [RREPS]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas [NETSARC]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.

Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.

With the financial support of the French National Cancer Institute [Institut National du cancer [INCa]).

ReferenceType: result

ReferenceCitation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honoré C, Sargos P, Sunyach MP, Le Péchoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

family: Savina

full_name: Marion Savina

given: Marion

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Mir

full_name: Olivier Mir

given: Olivier

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Cousin

full_name: Sophie Cousin

family: Terrier

full_name: Philippe Terrier

given: Philippe

family: Ranchere-Vince

full_name: Dominique Ranchere-Vince

given: Dominique

family: Meeus

full_name: Pierre Meeus

given: Pierre

family: Stoeckle

full_name: Eberhard Stoeckle

given: Eberhard

family: Honoré

full_name: Charles Honoré

given: Charles

family: Sargos

full_name: Paul Sargos

given: Paul

family: Sunyach

full_name: Marie-Pierre Sunyach

given: Marie-Pierre

family: Le Péchoux

full_name: Cécile Le Péchoux

given: Cécile

family: Giraud

full_name: Antoine Giraud

given: Antoine

family: Bellera

full_name: Carine Bellera

given: Carine

family: Le Loarer

full_name: François Le Loarer

given: François

family: Italiano

full_name: Antoine Italiano

currency_apc_doaj: GBP

journal_name: BMC Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

ReferenceCitation: Toulmonde M, Bonvalot S, Méeus P, Stoeckle E, Riou O, Isambert N, Bompas E, Jafari M, Delcambre-Lair C, Saada E, Le Cesne A, Le Péchoux C, Blay JY, Piperno-Neumann S, Chevreau C, Bay JO, Brouste V, Terrier P, Ranchère-Vince D, Neuville A, Italiano A; French Sarcoma Group. Retroperitoneal sarcomas: patterns of care at diagnosis, prognostic factors and focus on main histological subtypes: a multicenter analysis of the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):735-742. doi: 10.1093/annonc/mdt577.

ReferenceCitation: Blay JY, Soibinet P, Penel N, Bompas E, Duffaud F, Stoeckle E, Mir O, Adam J, Chevreau C, Bonvalot S, Rios M, Kerbrat P, Cupissol D, Anract P, Gouin F, Kurtz JE, Lebbe C, Isambert N, Bertucci F, Toumonde M, Thyss A, Piperno-Neumann S, Dubray-Longeras P, Meeus P, Ducimetière F, Giraud A, Coindre JM, Ray-Coquard I, Italiano A, Le Cesne A. Improved survival using specialized multidisciplinary board in sarcoma patients. Ann Oncol. 2017 Nov 1;28(11):2852-2859. doi: 10.1093/annonc/mdx484.

location_facility: Institut Gustave Roussy, Comprehensive Cancer Center

location_facility: Institut Bergonié, Comprehensive Cancer Center


title: Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients

acronym: PARKIDENT

summary: This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease

primary_purpose: Basic Science

intervention_type: Behavioral


type: Registry Identifier

title: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

acronym: StatinflaSAS

summary:
The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

ReferenceType: background

ReferenceCitation: Bergeron C, Kimoff J, Hamid Q. Obstructive sleep apnea syndrome and inflammation. J Allergy Clin Immunol. 2005 Dec;116(6):1393-6.

ReferenceCitation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.

name: HP2; INSERM, U1042University Grenoble Alpes Grenoble France

family: Jullian‐Desayes

full_name: Ingrid Jullian‐Desayes

given: Ingrid

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

name: Hepato‐Gastro‐Enterology DepartmentCHU Grenoble Grenoble France

family: Zarski

full_name: Jean‐Pierre Zarski

given: Jean‐Pierre

name: Endocrinology and Nutrition DepartmentAP‐HP, La Pitié‐Salpétrière, Hospital Paris France

name: Nutriomic DepartmentINSERM, UMRS 872, University Pierre and Marie Curie‐Paris 6 Paris France

family: Aron‐Wisnewsky

full_name: Judith Aron‐Wisnewsky

given: Judith

family: Launois‐Rollinat

full_name: Sandrine H. Launois‐Rollinat

given: Sandrine H.

name: Biochemistry, Toxicology and Pharmacology DepartmentCHU Grenoble Grenoble France

family: Trocme

full_name: Candice Trocme

given: Candice

family: Levy

full_name: Patrick Levy

given: Patrick

family: Joyeux‐Faure

full_name: Marie Joyeux‐Faure

given: Marie

family: Pepin

full_name: Jean‐Louis Pepin

given: Jean‐Louis

journal_name: Respirology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Joyeux-Faure M, Tamisier R, Baguet JP, Dias-Domingos S, Perrig S, Leftheriotis G, Janssens JP, Trzepizur W, Launois SH, Stanke-Labesque F, Lévy PA, Gagnadoux F, Pepin JL. Response to statin therapy in obstructive sleep apnea syndrome: a multicenter randomized controlled trial. Mediators Inflamm. 2014;2014:423120. doi: 10.1155/2014/423120. Epub 2014 Aug 25.

name: University Grenoble Alpes, HP2, Inserm U1042, Grenoble, France

name: CHU de Grenoble, Laboratoire EFCR, Clinique Universitaire de Physiologie, Grenoble, France

family: Joyeux-Faure

full_name: Marie Joyeux-Faure

name: Laboratoire EFCR, Pôle Thorax et Vaisseaux, CHU de GRENOBLE CS 10217, 38043 Grenoble, France

name: CHU de Grenoble, Clinique de Cardiologie, Grenoble, France

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Dias-Domingos

full_name: Sonia Dias-Domingos

given: Sonia

name: Laboratoire du Sommeil, Service de Neuropsychiatrie, Hôpital Belle Idée, Genève, Switzerland

family: Perrig

full_name: Stephen Perrig

given: Stephen

name: Laboratoire d’explorations Fonctionnelles Vasculaires, CHU d’Angers, Angers, France

family: Leftheriotis

full_name: Georges Leftheriotis

given: Georges

name: Service de Pneumologie, Hôpital Universitaire de Genève, Genève, Switzerland

family: Janssens

full_name: Jean-Paul Janssens

given: Jean-Paul

name: CHU d’Angers, Département de Pneumologie, Angers, France

name: Université d’Angers, Inserm 1063 “SOPAM”, Angers, France

family: Trzepizur

full_name: Wojciech Trzepizur

given: Wojciech

family: Launois

full_name: Sandrine H. Launois

name: CHU de Grenoble, Département de Biochimie, Toxicologie et Pharmacologie, Grenoble, France

family: Stanke-Labesque

full_name: Françoise Stanke-Labesque

given: Françoise

family: Lévy

full_name: Patrick A. Lévy

given: Patrick A.

repository_institution: University of Geneva - Archive ouverte UNIGE

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

title: Response to Statin Therapy in Obstructive Sleep Apnea Syndrome: A Multicenter Randomized Controlled Trial

location_facility:
Hospital of Annemasse
Universitary Hospital of Angers
University Hospital of Grenoble
Universitary Hospital of Geneva


title: Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation

acronym: Tocihelper

summary:
Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on professional antigen-presenting cells, differentiate into different effector cells:

Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against intracellular pathogens;
Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses and immunity against parasites;
Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by tissue cells.

An additional TH subset called follicular helper T (Tfh) cells has recently been identified in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate B-cell maturation and immunoglobulin production during normal immune responses. They produce factors essential for B cell selection and maturation into memory B-cells or long-lived antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic autoantibody production in systemic autoimmunity, and therefore could potentially represent a novel therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is characterized by the presence of ectopic lymphoid structures, resembling germinal centers. Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and synthesis of pathogenic autoantibody production, thus potentiating tissue injury. Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis.

IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6 effects impact the observed clinical response. Recently, Samson et al have demonstrated that Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B cell compartment. They showed a significant reduction in the frequency of peripheral pre-switch and post-switch memory B cells but also a reduction of serum immunoglobulin levels, that could be the reflect of TCZ on Tfh cells development, circulation and/or function.

Most of the work studying the role of IL-6 on Tfh cells development has been performed in mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that cytokines alone are insufficient to drive Tfh cells differentiation.

To better understand the impact of IL-6 on human Tfh cells, the investigators would like to conduct a prospective study in patients with active RA and investigated the effects of blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be explored in vitro.

lead_sponsor: Association Aquitaine de Recherche Clinique en Rhumatologie

location_facility: Rheumatology department - Bordeaux University Hospital


title: A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study

summary: The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

lead_sponsor: AstraZeneca

location_facility:
Research site
Research Site
Research Sites


title: An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer

summary: The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.


type: Other Grant/Funding Number

title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer

acronym: PROVE

summary: Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.

status: Unknown status

primary_purpose: Prevention

ipd_sharing: Undecided

location_facility: Groupement Hospitalier Est Hospices civils de Lyon

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hôpital Avicenne, Hôpitaux universitaires Paris Seine-

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier de Versailles André Mignot


title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

summary: The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

ReferenceCitation: Bouvard S, Faure P, Roucard C, Favier A, Halimi S. Characterization of free radical defense system in high glucose cultured HeLa-tat cells: consequences for glucose-induced cytotoxicity. Free Radic Res. 2002 Sep;36(9):1017-22.

ReferenceCitation: Halimi S, Wion-Barbot N, Lambert S, Benhamou P. [Self-monitoring of blood glucose in type 2 diabetic patients. What could we propose according to their treatment?]. Diabetes Metab. 2003 Apr;29(2 Pt 2):S26-30. Review. French.

ReferenceCitation: Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. Review. French.

ReferenceCitation: Halimi S. [Is a new therapeutic class justified in the treatment of type 2 diabetes?]. Ann Endocrinol (Paris). 2002 Apr;63(2 Pt 2):1S7-11. Review. French.

ReferenceCitation: Halimi S, Charpentier G, Grimaldi A, Grenier JL, Baut F, Germain B, Magnette J. Effect on compliance, acceptability of blood glucose self-monitoring and HbA(1c) of a self-monitoring system developed according to patient's wishes. The ACCORD study. Diabetes Metab. 2001 Dec;27(6):681-7.

lead_sponsor: University Hospital, Grenoble

location_facility: Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble

location_facility: Department of Endocrinology, Diabetology and Nutrition

location_facility: Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble

intervention_type: Procedure


type: Other Identifier

title: Study of Morphology and Functional Magnetic Resonance Imaging (MRI) Muscle Patients With Muscular Dystrophy Type FSHD Benefiting a Physical Training Introduced.

summary:
The safety of guided practice of physical activity in myopathies is increasingly accepted, including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most common muscular dystrophy, the aerobic training showed its physiological and functional efficiency without affecting the quality of life of patients. The issue of exercise therapy extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use of a training program combining endurance exercise targeted exercises and strength is even more relevant.

To complete the multidimensional assessments be managed by each team ( physiological assessments, functional tissue and quality of life) it is relevant to continue , for a descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint-Etienne
CHU de Grenbole


title: A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma

summary:
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.

Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.

ReferenceCitation: O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. Epub 2004 Dec 21.

ReferenceCitation: Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. Epub 2004 Dec 21.

lead_sponsor: Lymphoma Study Association

location_country: Belgium France

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: A 48-Weeks National Multicenter Randomized Open Clinical Trial Evaluating Tolerance and Efficacy of a Treatment Simplification by Lopinavir/Ritonavir Versus Continuation of Current Treatment in HIV-Infected Patients With a Viral Load Inferior to 50 Copies/mL Since 6 Months At Least

acronym: KALESOLO

summary: The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients

ReferenceCitation: Mocroft A, Ledergerber B, Katlama C, Kirk O, Reiss P, d'Arminio Monforte A, Knysz B, Dietrich M, Phillips AN, Lundgren JD; EuroSIDA study group. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003 Jul 5;362(9377):22-9.

ReferenceCitation: Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S, Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA. 2004 Jul 14;292(2):251-65.

ReferenceCitation: Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77.

ReferenceCitation: Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60.

ReferenceCitation: Murphy R, Gazzard B. Antiretroviral treatment guidelines. AIDS. 2003 Jun;17 Suppl 2:S1.

ReferenceCitation: Bucher HC, Kofler A, Nüesch R, Young J, Battegay M, Opravil M. Meta-analysis of randomized controlled trials of simplified versus continued protease inhibitor-based antiretroviral therapy in HIV-1-infected patients. AIDS. 2003 Nov 21;17(17):2451-9.

ReferenceCitation: Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis. 2002 Nov 15;35(10):1219-30. Epub 2002 Oct 21. Review.

ReferenceCitation: Martínez E, Conget I, Lozano L, Casamitjana R, Gatell JM. Reversion of metabolic abnormalities after switching from HIV-1 protease inhibitors to nevirapine. AIDS. 1999 May 7;13(7):805-10.

ReferenceCitation: Moyle G, Baldwin C, Mandalia S, Comitis S, Burn P, Gazzard B. Changes in metabolic parameters and body shape after replacement of protease inhibitor With efavirenz in virologically controlled HIV-1-positive persons: single-arm observational cohort. J Acquir Immune Defic Syndr. 2001 Dec 1;28(4):399-401.

ReferenceCitation: Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.

name: INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique (IPLESP), Paris, France

name: AP-HP, Laboratoire de Virologie, Hôpital Saint-Antoine, Paris, France

family: Lambert-Niclot

full_name: Sidonie Lambert-Niclot

given: Sidonie

family: Grude

full_name: Maxime Grude

given: Maxime

name: Département de Maladies Infectieuses, Hôpital Saint-Antoine, Paris, France

family: Meynard

full_name: Jean-Luc Meynard

given: Jean-Luc

name: AP-HP, Laboratoire de Virologie, Hôpital Pitié Salpêtrière, Paris, France

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

name: Département de Maladies Infectieuses, Hôpital Pitié Salpêtrière, Paris

family: Valantin

full_name: Marc-Antoine Valantin

given: Marc-Antoine

family: Flandre

full_name: Philippe Flandre

given: Philippe

name: Université Toulouse III Paul-Sabatier, Toulouse, France

name: CHU de Toulouse, Laboratoire de Virologie, Toulouse, France

family: Izopet

full_name: Jacques Izopet

given: Jacques

name: Inserm, Bordeaux Population Health Research Center, Université Bordeaux, ISPED, Bordeaux, France

name: CHU de Bordeaux, Pole de Sante Publique, Bordeaux, France

family: Moinot

full_name: Laetitia Moinot

given: Laetitia

family: Bouteloup

full_name: Vincent Bouteloup

given: Vincent

family: Calvez

full_name: Vincent Calvez

family: Katlama

full_name: Christine Katlama

given: Christine

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Morand-Joubert

full_name: Laurence Morand-Joubert

given: Laurence

journal_name: Clinical Infectious Diseases

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Meynard JL, Bouteloup V, Landman R, Bonnard P, Baillat V, Cabie A, Kolta S, Izopet J, Taburet AM, Mercie P, Chene G, Girard PM; KALESOLO Study Group. Lopinavir/ritonavir monotherapy versus current treatment continuation for maintenance therapy of HIV-1 infection: the KALESOLO trial. J Antimicrob Chemother. 2010 Nov;65(11):2436-44. doi: 10.1093/jac/dkq327. Epub 2010 Sep 15.

full_name: J.-L. Meynard

full_name: V. Bouteloup

given: V.

family: Landman

full_name: R. Landman

given: R.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Hôpital Côte de Nacre - Service des Maladies Infectieuses

location_facility: Hôpital Gustave Dron - Service des Maladies Infectieuses

location_facility: Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Henri Mondor - Service d'Immunologie Clinique

location_facility: Hôpital Pontchaillou - Service des Maladies Infectieuses

location_facility: Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie

location_facility: Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie

location_facility: Hôpital Sainte-Marguerite - Unité Médicale CISIH

location_facility: Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales

location_facility: Hôpital Bicêtre - Service de Médecine Interne

location_facility: Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales

location_facility: Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1

location_facility: Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses

location_facility: Hôpital A. Michallon - Service des Maladies Infectieuses

location_facility: Hôpital de l'Archet - Service d'Infectiologie

location_facility: Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Jean Verdier - Unité de Maladies Infectieuses

location_facility: Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

location_facility: Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses

location_facility: Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales


title: Efficacy of a Multi-component Treatment Program Integrating Cognitive - Affective - Addictive Based Intervention in Obese Patients: a Prospective Multicentric Randomized Clinical Trial

acronym: OBESADEM

summary:
Since the 80's, the prevalence of obesity has more than doubled and despite progression of knowledge, interventions usually lead to a transient reduction in body weight that is not maintained in the long-term. These failures in weight management may be partly explained by an incomplete understanding of obesity risk and maintaining factors.

Behavioral and neurobiological similarities between use of high palatable foods and addictive psychoactive drugs have led to the concept of food addiction. Addiction is defined as a loss of control of use, and its persistence despite accumulation of negative consequences. Craving, an uncontrollable and involuntary urge to use, has shown to be a core determinant of persistent use and relapse in addiction. Recent studies have established that food addiction, craving and emotional eating concern a large part of obese patients, and that food addiction may explain some negative outcomes of weight loss treatments, such as unsuccessful attempts to reduce calories and early termination of treatment programs.

Recent advances in neuropsychiatry suggest that an imbalanced interplay between cognitive and affective processes impedes self-control and enhances over- or under-controlled behaviors. In the field of food intake and weight management, there is increasing evidence that besides environmental factors, inefficient executive functions and emotion regulation skills are salient phenomena underlying habit-forming processes that are present in eating disorder subtypes as well as obesity. This has led some authors to consider disordered eating behaviors as 'allostatic' reactions by which the modulation of food intake is used by vulnerable individuals to adjust to craving, maladaptive cognitive and/or emotional strategies.

Current recommendations emphasize the need for translating these discoveries into treatments to promote healthy eating and weight management.

Over the last 5 years, a growing base of clinical and behavioural studies have indicated that, individually, Cognitive-Behavioural Therapy (CBT), Emotional Skills Training (EST), and Cognitive Remediation Therapy (CRT) are promising techniques to decrease disordered eating behaviors, including craving.

The investigators hypothesize that addition to treatment as usual (TAU) of a specific program targeting executive functions, emotional regulation, and addictive-like eating behaviors, could have a beneficial impact on reported food craving, and improve weight management among obese patients.

primary_purpose: Supportive Care

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Européen Georges Pompidou

location_facility: Assistance Publique Hôpitaux de Paris Hôpital Ambroise Paré


title: Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

summary: The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.

ReferenceCitation: Lablanche JM, Leone A, Merkely B, Morais J, Alonso J, Santini M, Eha J, Demil N, Licour M, Tardif JC; CENTAURUS investigators. Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis. 2010 Mar;103(3):160-9. doi: 10.1016/j.acvd.2010.01.005. Epub 2010 Apr 8.

family: Lablanche

full_name: Jean-Marc Lablanche

given: Jean-Marc

family: Leone

full_name: Attilio Leone

given: Attilio

family: Merkely

full_name: Bela Merkely

given: Bela

family: Morais

full_name: João Morais

given: João

family: Alonso

full_name: Joaquim Alonso

given: Joaquim

family: Santini

full_name: Massimo Santini

given: Massimo

family: Eha

full_name: Jaan Eha

given: Jaan

family: Demil

full_name: Nacima Demil

given: Nacima

family: Licour

full_name: Muriel Licour

given: Muriel

family: Tardif

full_name: Jean-Claude Tardif

given: Jean-Claude

journal_name: Archives of Cardiovascular Diseases

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: Results of the CENTAURUS study

location_country: Italy Spain France Greece Tunisia Hungary Belgium Ireland Portugal Estonia Canada

location_facility:
Research site
Research Site


title: Impact of Clinical, Echocardiographic and Biological Parameters to the Risk of Cardiovascular Disease in Patients With Non-valvular Atrial Fibrillation.

acronym: FASTRHAC

summary: The aim of the present prospective study is to further develop and validate a composite risk score predicting both ischemic and bleeding risk, based on epidemiologic, clinical, biological, and/or morphologic complementary data. First, the investigators will assess the predictive performance of current clinical risk scores. Second, the investigators will assess the potential predictive value of additional markers. Third, the investigators will aim to develop a new risk score.

ipd_sharing: Yes

ipd_sharing_description: each participant can have access to its data by asking the investigator of the study.

lead_sponsor: Saint Antoine University Hospital

location_facility: Service de cadiologie - Hôpital Pitié Salpêtrière

location_facility: Service de cardiologie - Clinique Pasteur

location_facility: Service de cardiologie - hôpital Saint Antoine


title: Evaluation of the Beckman Coulter Access Anti-HCV Assay as an Aid in the Diagnosis of HCV Infection: EU Clinical Trial Protocol

summary: The objective of this study was the collection and testing of clinical samples to determine the clinical performance in terms of diagnostic accuracy measured by specificity and sensitivity of the Access anti-Hepatitis C Virus (anti-HCV) assay on the DxI 9000 Access Immunoassay Analyzer. The Design Input Document (DID) indicates performance requirements and minimum target enrollment numbers (based on those in the CTS) of blood donor, hospitalized patient and known HCV antibody (Ab) positive samples for novel anti-HCV assays. A secondary objective was to determine the false initial reactive rate (IRR) of the Access anti-HCV assay.

time_perspective: Other

lead_sponsor: Beckman Coulter, Inc.

location_facility: Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

intervention_type: Diagnostic Test


title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib at 7.5 mg/kg/Day to Imatinib at 400 or 600 mg in Treatment of Patients With Gastro-intestinal Stromal Tumor in First Line Medical Treatment

summary: Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

lead_sponsor: AB Science

location_country:
United States
France
Lebanon

location_facility: Middle East Institute of Health- Bsaleem

location_facility: Groupe Hospitalier Diaconesse Croix Saint Simon

location_facility: Hammoud Hospital University Medical Center


title: Papillomavirus Load in Rheumatic Inflammatory Diseases

acronym: PAPLOR

summary:
Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.

Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.

In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.

Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.

location_facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France

location_facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Hopital Edouard Herriot - service de rhumatologie


title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

summary: The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.

ReferenceCitation: Deplanque G, Demarchi M, Hebbar M, Flynn P, Melichar B, Atkins J, Nowara E, Moyé L, Piquemal D, Ritter D, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Hammel P. A randomized, placebo-controlled phase III trial of masitinib plus gemcitabine in the treatment of advanced pancreatic cancer. Ann Oncol. 2015 Jun;26(6):1194-1200. doi: 10.1093/annonc/mdv133. Epub 2015 Apr 9.

family: Deplanque

full_name: G. Deplanque

given: G.

family: Demarchi

full_name: M. Demarchi

given: M.

family: Hebbar

full_name: M. Hebbar

family: Flynn

full_name: P. Flynn

given: P.

family: Melichar

full_name: B. Melichar

given: B.

family: Atkins

full_name: J. Atkins

given: J.

family: Nowara

full_name: E. Nowara

given: E.

family: Moyé

full_name: L. Moyé

given: L.

family: Piquemal

full_name: D. Piquemal

given: D.

family: Ritter

full_name: D. Ritter

family: Dubreuil

full_name: P. Dubreuil

family: Mansfield

full_name: C.D. Mansfield

family: Acin

full_name: Y. Acin

given: Y.

family: Moussy

full_name: A. Moussy

given: A.

family: Hermine

full_name: O. Hermine

given: O.

family: Hammel

full_name: P. Hammel

journal_name: Annals of Oncology

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

location_country:
Lebanon
France
Czechia
Romania
United States

location_facility: Department of Oncology Teaching Hospital Olomouc

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Centre Hospitalier Belfort - Montbéliard

location_facility: Groupement Hospitalier Universitaire Nord - Beaujon

location_facility: Eastern Connecticut Hematology and Oncology (ECHO)


title: Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers

acronym: COVISTRESS HRV

summary: The COVID-19 pandemic is an exceptional and particularly anxiety-provoking health situation. In particular, for healthcare professionals who come into contact with patients who are contaminated or suspected of contamination, such as emergency rooms. The management of these patients requires reinforced protective equipment. However, in the context of this pandemic, data is currently non-existent on the objective measurement of the stress of these professionals. Sinus variability of heart rate is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc.).

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia

acronym: PARTEM

summary:
The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers.

The secondary objectives of this study are to:

Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies;
Report the safety of PAE;
Evaluate patient's adherence to medical treatment;
Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.

status: Active, not recruiting

location_facility: CHU Montpellier hopital Arnaud de Villeneuve

location_facility: CHU de Bordeaux groupe hospitalier Pellegrin


title: Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1

summary:
The main objective of the study is to investigate the determinants of the quality of life in children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific impact of neuropsychological deficits. In fact, cognitive impairment is currently considered as one of the most pervasive features of this genetic disorder but its relationship with the worsening of quality of life found in this population has not been directly investigated to date.

Secondary objectives of this study are (i) to compare neuropsychological and quality of life measures between patients and healthy controls matched by age, gender and education level, (ii) to contrast neuropsychological deficits incidence between patients and controls, and (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.

The main hypothesis of this study is that the neuropsychological impairment classically identified in this clinical population will be associated to the quality of life's worsening both in children and adults.

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Assistance Publique - Hôpitaux de Paris (Hôpital Henri Mondor)


title: Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months

summary: This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.

lead_sponsor: Nestlé

location_country: Italy France

location_facility: Istituto di Ostetricia e Ginecologia Neonatalogia


title: Evaluation of the Implementation of the Accu-Chek Inform Cobas IT 1000 System in Three Medical Hospital Departments: Impact on the Management of Diabetes

acronym: COBAS

summary: The principal objective of this single-center 2-period study is to evaluate the glycemic control of in-patients in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care) as the rate of capillary blood glucose measurements within a pre-define target range, and to compare results during the period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated) and period II (warning activated).

ReferenceCitation: Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77.

ReferenceCitation: ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. Review.

ReferenceCitation: Inzucchi SE, Rosenstock J. Counterpoint: Inpatient glucose management: a premature call to arms? Diabetes Care. 2005 Apr;28(4):976-9. Review.

ReferenceCitation: Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. Review. Erratum in: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255.

ReferenceCitation: Halimi S. [Benefits of blood glucose self-monitoring in the management of insulin-dependent (IDDM) and non-insulin-dependent diabetes (NIDDM). Analysis of the literature: mixed results]. Diabetes Metab. 1998 Nov;24 Suppl 3:35-41. Review. French.

ReferenceCitation: King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31.

ReferenceCitation: Mise en place et conduite en France d'essais cliniques portant sur des dispositifs médicaux et dispositifs médicaux de diagnostic in vitro.Afssaps September 2006, 15. http://agmed.sante.gouv.fr


title: Cerebral Substrates of Prospective Memory in Healthy Young Adults and Disruptions in Normal Aging and Alzheimer Disease: a Study in Anatomical, Functional and Diffusion Tensor MRI.

acronym: IMPRO

summary: The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients.

lead_sponsor: University Hospital, Caen

location_facility:
MRSH - University of Caen
GIP Cyceron
University Hospital Côte de Nacre


title: Evaluate the Effects of a Preventive Care at Home on Young Child's Development

acronym: PERL

summary:
The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry.

An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population.

If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child.

This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions.

A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group.

A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.

ReferenceCitation: Buchheit S, Kabuth B, Colombo MC, Ligier F. Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France. Front Psychiatry. 2021 Jun 30;12:641468. doi: 10.3389/fpsyt.2021.641468. eCollection 2021.

family: Buchheit

full_name: Sophie Buchheit

given: Sophie

family: Kabuth

full_name: Bernard Kabuth

given: Bernard

family: Colombo

full_name: Marie-Christine Colombo

given: Marie-Christine

family: Ligier

full_name: Fabienne Ligier

given: Fabienne

currency_apc_doaj: USD

journal_name: Frontiers in Psychiatry

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre Psychothérapique de Nancy


title: Impact of Comprehensive Geriatric Assessment on Malnutrition, Functional Status and Survival in Elderly Patients With Head and Neck Squamous Cell Carcinomas (HNSCCs): a Randomized Controlled Multicenter Clinical Trial

acronym: EGéSOR

summary: The intervention tested in this research project aims to reduce this inequality by improving the management of elderly head and neck cancer patients with a specific management. Indeed, the treatment of elderly head and neck cancer patients has specificities concerning treatment options, their tolerance, psychological management, nutritional and functional status, and support needed at home. To assess the overall needs of the elderly patients, an assessment known as "comprehensive geriatric assessment" (CGA) can be performed by a geriatrician with extensive testing and questionnaires. This assessment is long and requires an experienced geriatrician. It leads to the development of an individualized treatment plan (physiotherapy, psychological follow-up, support at home, nutritional management ...) and follow-up to adapt the necessary cares for the duration of the cancer treatment. The CGA utility has been studied in elderly patients with nonmalignant diseases. Studies have shown that CGA allowed improving survival and maintaining the elderly at home.

ReferenceCitation: Abstracts of the 6th European Congress of Oto-Rhino-Laryngology Head and Neck Surgery, June 30-July 4, 2007, Vienna, Austria. Eur Arch Otorhinolaryngol. 2007 Jun;264 Suppl 1:S1-354.

ReferenceCitation: Homma A, Sakashita T, Oridate N, Suzuki F, Suzuki S, Hatakeyama H, Mizumachi T, Taki S, Fukuda S. Importance of comorbidity in hypopharyngeal cancer. Head Neck. 2010 Feb;32(2):148-53. doi: 10.1002/hed.21158.

ReferenceCitation: Brugel L, Laurent M, Caillet P, Radenne A, Durand-Zaleski I, Martin M, Baron M, de Kermadec H, Bastuji-Garin S, Canouï-Poitrine F, Paillaud E. Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR). BMC Cancer. 2014 Jun 13;14:427. doi: 10.1186/1471-2407-14-427.

family: Brugel

full_name: Lydia Brugel

given: Lydia

family: Laurent

full_name: Marie Laurent

given: Marie

family: Caillet

full_name: Philippe Caillet

given: Philippe

family: Radenne

full_name: Anne Radenne

given: Anne

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Martin

full_name: Michel Martin

given: Michel

family: Baron

full_name: Melany Baron

given: Melany

family: de Kermadec

full_name: Héloïse de Kermadec

given: Héloïse

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

family: Canouï-Poitrine

full_name: Florence Canouï-Poitrine

given: Florence

family: Paillaud

full_name: Elena Paillaud

given: Elena

journal_name: BMC Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility: Centre Hospitalier Intercommunal de Créteil / Hopital Henri Mondor


title: A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer

acronym: PICC One Day

summary:
Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.

status: Withdrawn

primary_purpose: Other

lead_sponsor: Centre Leon Berard


title: Strategy for Preventing Cardiovascular and Renal Events Based on ARTErial Stiffness

acronym: SPARTE

summary: Randomised two parallel groups multicenter study using a Prospective Randomised Open Blinded End-point design (PROBE), aiming at comparing the efficacy of a therapeutic strategy targeting the normalisation of arterial stiffness for reducing cardiovascular (CV) and renal events, in comparison with a classical therapeutic strategy implementing the European Society of Hypertension-European Society of Cardiology (ESH-ESC) Guidelines, in patients with essential hypertension and medium-to-very high CV risk.

ReferenceCitation: Laurent S, Briet M, Boutouyrie P. Arterial stiffness as surrogate end point: needed clinical trials. Hypertension. 2012 Aug;60(2):518-22. doi: 10.1161/HYPERTENSIONAHA.112.194456. Epub 2012 Jun 25. Review.

ReferenceCitation: Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. Epub 2006 Sep 25.

ReferenceCitation: Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Clinical Investigation Center, Hopital Europeen Georges Pompidou


title: Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate: an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Recent meta-analysis have suggested that the safety of oral care with chlorhexidine in patients under mechanical ventilation could be questionable. Whatever the hypothetical mechanisms involved (direct cellular toxicity, underdiagnosis of Ventilator-Associated Pneumonia), presence of chlorhexidine in tracheal secretions after routine oral care is the cornerstone of this potential side effect of the routine oral care with chlorhexidine gluconate. The DEMETER study assessing the medico-economical impact of the subglottic secretions drainage study (NCT02515617) provides the opportunity to perform this proof of concept study (detection of chlorhexidine in tracheal secretions after routine oral care with chlorhexidine gluconate) and to evaluate the impact of the subglottic secretion drainage on this potential detection of chlorhexidine.

This ancillary study will be performed in one of the centers participating to the DEMETER study.

ReferenceCitation: Klompas M, Speck K, Howell MD, Greene LR, Berenholtz SM. Reappraisal of routine oral care with chlorhexidine gluconate for patients receiving mechanical ventilation: systematic review and meta-analysis. JAMA Intern Med. 2014 May;174(5):751-61. doi: 10.1001/jamainternmed.2014.359. Review.

ReferenceCitation: Price R, MacLennan G, Glen J; SuDDICU Collaboration. Selective digestive or oropharyngeal decontamination and topical oropharyngeal chlorhexidine for prevention of death in general intensive care: systematic review and network meta-analysis. BMJ. 2014 Mar 31;348:g2197. doi: 10.1136/bmj.g2197. Review.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Effects of Memantine on Cognitive Disorders of Relapsing-remitting Multiple Sclerosis

summary: The purpose of this study is to determine if memantine is effective in the treatment on cognitive disorders of Relapsing - Remitting multiple sclerosis. m

ReferenceCitation: Peyro Saint Paul L, Creveuil C, Heinzlef O, De Seze J, Vermersch P, Castelnovo G, Cabre P, Debouverie M, Brochet B, Dupuy B, Lebiez P, Sartori É, Clavelou P, Brassat D, Lebrun-Frenay C, Daplaud D, Pelletier J, Coman I, Hautecoeur P, Tourbah A, Defer G. Efficacy and safety profile of memantine in patients with cognitive impairment in multiple sclerosis: A randomized, placebo-controlled study. J Neurol Sci. 2016 Apr 15;363:69-76. doi: 10.1016/j.jns.2016.02.012. Epub 2016 Feb 6.

family: Peyro Saint Paul

full_name: Laure Peyro Saint Paul

given: Laure

family: Creveuil

full_name: Christian Creveuil

given: Christian

family: Heinzlef

full_name: Olivier Heinzlef

given: Olivier

family: De Seze

full_name: Jerome De Seze

given: Jerome

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Castelnovo

full_name: Giovanni Castelnovo

given: Giovanni

family: Cabre

full_name: Philippe Cabre

family: Debouverie

full_name: Marc Debouverie

given: Marc

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Dupuy

full_name: Benoit Dupuy

given: Benoit

family: Lebiez

full_name: Pierre Lebiez

given: Pierre

family: Sartori

full_name: Éric Sartori

given: Éric

family: Clavelou

full_name: Pierre Clavelou

family: Brassat

full_name: David Brassat

given: David

family: Lebrun-Frenay

full_name: Christine Lebrun-Frenay

given: Christine

family: Daplaud

full_name: David Daplaud

family: Pelletier

full_name: Jean Pelletier

given: Jean

family: Coman

full_name: Irène Coman

given: Irène

family: Hautecoeur

full_name: Patrick Hautecoeur

family: Tourbah

full_name: Ayman Tourbah

given: Ayman

family: Defer

full_name: Gilles Defer

given: Gilles

journal_name: Journal of the Neurological Sciences


title: Transurethral Resection of the Prostate With Photo Selective Vaporization of the Prostate Using the High Powered 532nm Laser Obstructive Benign Prostatic Hyperplasia Management: Focus on Efficiency and Cost-effectiveness

acronym: REVAPRO

summary: The aim of this study is to compare medical efficacy and cost effectiveness of two surgical options for obstructive BPH management : transurethral resection of the prostate with photo selective vaporization of the prostate using the high powered 532nm laser.

ReferenceCitation: Bachmann A, Schürch L, Ruszat R, Wyler SF, Seifert HH, Müller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. Epub 2005 Jul 18.

ReferenceCitation: Lukacs B, Loeffler J, Bruyère F, Blanchet P, Gelet A, Coloby P, De la Taille A, Lemaire P, Baron JC, Cornu JN, Aout M, Rousseau H, Vicaut E; REVAPRO Study Group. Photoselective vaporization of the prostate with GreenLight 120-W laser compared with monopolar transurethral resection of the prostate: a multicenter randomized controlled trial. Eur Urol. 2012 Jun;61(6):1165-73. doi: 10.1016/j.eururo.2012.01.052. Epub 2012 Feb 8.

family: Lukacs

full_name: Bertrand Lukacs

given: Bertrand

family: Loeffler

full_name: Joyce Loeffler

given: Joyce

family: Bruyère

full_name: Franck Bruyère

given: Franck

family: Blanchet

full_name: Pascal Blanchet

given: Pascal

family: Gelet

full_name: Albert Gelet

given: Albert

family: Coloby

full_name: Patrick Coloby

family: De la Taille

full_name: Alexandre De la Taille

given: Alexandre

family: Lemaire

full_name: Philippe Lemaire

given: Philippe

family: Baron

full_name: Jean-Christophe Baron

given: Jean-Christophe

family: Cornu

full_name: Jean-Nicolas Cornu

given: Jean-Nicolas

family: Aout

full_name: Mounir Aout

given: Mounir

family: Rousseau

full_name: Helene Rousseau

given: Helene

family: Vicaut

full_name: Eric Vicaut

given: Eric

journal_name: European Urology

title: Photoselective Vaporization of the Prostate with GreenLight 120-W Laser Compared with Monopolar Transurethral Resection of the Prostate: A Multicenter Randomized Controlled Trial


title: Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis

acronym: IMPACT

summary: Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

ReferenceCitation: Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701.

ReferenceCitation: Senkal M, Zumtobel V, Bauer KH, Marpe B, Wolfram G, Frei A, Eickhoff U, Kemen M. Outcome and cost-effectiveness of perioperative enteral immunonutrition in patients undergoing elective upper gastrointestinal tract surgery: a prospective randomized study. Arch Surg. 1999 Dec;134(12):1309-16.

ReferenceCitation: Braga M, Gianotti L, Radaelli G, Vignali A, Mari G, Gentilini O, Di Carlo V. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999 Apr;134(4):428-33.

lead_sponsor: Rennes University Hospital

location_facility: Service de Réanimation Chirurgicale - Hôpital Pontchaillou


title: Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease

acronym: COVARAD

summary: Three quarters of patients with Alzheimer's disease have at least one vascular risk factor (VRF). Vascular brain lesions are present in most Alzheimer's patients (especially older ones). This cerebrovascular disease potentiates Alzheimer's lesions in early-stage disease. Many research studies have shown that VRFs are also risk factors for Alzheimer's disease; this is true for arterial hypertension and dyslipidaemia in particular and, to a lesser extent, diabetes and cardiopathy. Moreover, recent drug trials (SYST-EUR, PROGRESS and HOPE) have indicated that antihypertensive medications can prevent the appearance of dementia (and notably Alzheimer's disease) in over-60 hypertensive subjects. An observational study of 233 Alzheimer's patients with an average follow-up period of 4 years has shown that the annual decline in the Mini-Mental State Examination (MMSE) score was lower in patients in whom all the VRFs were being treated than in patients in whom no VRFs were being treated (1.5 ± 2.5 points versus 2.5 ± 2 points, respectively; p<0.04).1 However, it is not currently known whether optimal treatment of VRFs can influence the progression and prognosis of Alzheimer's disease. Answering this question could have a significant impact on public health.

lead_sponsor: University Hospital, Lille

location_facility:
Ch Dr.Schaffner de Lens
Chu de Bordeaux - Talence
Groupe Hospitalier Seclin Carvin -
CH de DOUAI
CH de DENAIN
Hu Paris Centre Site Broca Aphp - Paris
CH Boulogne
CH Valenciennes
Centre Hospitalier Bethune Beuvry
Ch Calais -
CMRR Lille hopital Roger Salengro
Chu Rouen
Hôpital des Bâteliers, CHU
Ch Tourcoing
CH Saint-Philibert, GHICL
Chu Amiens Picardie
CH de ROUBAIX
CH ARRAS
Ch Dunkerque
Ch Le Quesnoy
Ch Region de St-Omer


title: Early Stages of Pancreatic Cancer Associated With Obesity and Metabolic Syndrome: Prevention and Screening Tools - Imaging of Fatty Pancreas in Humans: Correlation With Pathological Analysis

acronym: PAIR-PANCREAS

summary:
Obesity, diabetes and metabolic syndrome (MS) have all been associated with increase of pancreatic cancer (PK) risk. The precise role of obesity and diabetes and the pathways involved in the early oncogenic phases of PK associated with MS are not well known. The investigators hypothesize that it is possible to decipher this specific "fat-fibrosis-neoplastic sequence", to develop new imaging tools adapted to follow its progression, to test the benefit of treatments to slow this sequence and prevent the development of PK in obese and diabetic patients.This project is in line with a prevention strategy, by planning to understand the physiopathological pathways involved in MS leading to PK, to develop tools useful to screen early precancerous lesions in order to diagnose and treat patients at high risk, before cancer involvement.

This clinical trial is part of the INCA PAIR PANCREAS project : Early stages of pancreatic cancer associated with obesity and metabolic syndrome:

prevention and screening tools - Imaging of fatty pancreas in humans: correlation with pathological analysis, which includes 3 main coordinated objectives an in vitro approach an in vivo approach and this study (clinical approach).

intervention_type: Radiation


title: Anti Xa Activity in Cancer Patients Receiving Low-molecular-weight Heparin for Venous Thromboembolism

acronym: aXa

summary: Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a high risk of recurrent thromboembolism. The high rate of recurrence may result from alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.

ReferenceCitation: Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64.

ReferenceCitation: Khorana AA, Streiff MB, Farge D, Mandala M, Debourdeau P, Cajfinger F, Marty M, Falanga A, Lyman GH. Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. J Clin Oncol. 2009 Oct 10;27(29):4919-26. doi: 10.1200/JCO.2009.22.3214. Epub 2009 Aug 31. Review.

ReferenceCitation: Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658. Erratum in: Chest. 2008 Oct;134(4):892.

ReferenceCitation: Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53.

ReferenceCitation: Katz BZ, Muhl L, Zwang E, Ilan N, Herishanu Y, Deutsch V, Naparstek E, Vlodavsky I, Preissner KT. Heparanase modulates heparinoids anticoagulant activities via non-enzymatic mechanisms. Thromb Haemost. 2007 Dec;98(6):1193-9.

location_facility: Hôpital d'instruction des armees Desgenettes


summary: Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.

lead_sponsor: Institut National de la Recherche Agronomique


title: Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging

acronym: ULTRAFASTECHO

summary:
Arterial stiffness is associated with increased risk of cardiovascular events and death.

Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.

As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.

lead_sponsor: French Cardiology Society


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

acronym: OCCLURANDOM

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

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


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

acronym: ALADDIN

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

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

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

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

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

lead_sponsor: University Paris 7 - Denis Diderot

location_facility: Assistance Publique des Hopitaux de Paris


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

acronym: iTEPsein

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

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

location_facility:
Hospital
Institut de Cancérologie de l'Ouest


title: A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome

summary: The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.

lead_sponsor: Sanofi

location_country: Germany France Spain


title: A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome

summary: The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.

location_facility:
Sanofi- Aventis Administrative Office
Sanofi-Aventis Administrative Office


title: Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

acronym: PHAM

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

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

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


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

acronym: SLEEVERAS

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


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

summary:
Primary objective: safety and tolerability

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

Exploratory objectives: to characterize EYS606 biodistribution, immunogenicity and biomarkers

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

family: Touchard

full_name: Elodie Touchard

given: Elodie

family: Benard

full_name: Romain Benard

given: Romain

family: Bigot

full_name: Karine Bigot

given: Karine

family: Laffitte

full_name: Jean-Denis Laffitte

given: Jean-Denis

family: Buggage

full_name: Ronald Buggage

given: Ronald

family: Bordet

full_name: Thierry Bordet

given: Thierry

family: Behar-Cohen

full_name: Francine Behar-Cohen

given: Francine

journal_name: Journal of Controlled Release

lead_sponsor: Eyevensys

location_country:
United Kingdom
France

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

intervention_type: Biological


title: Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant

acronym: CARDAPAC

summary: Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

ReferenceCitation: Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.

apc_source: openAPC

family: Jacquinot

full_name: Quentin Jacquinot

given: Quentin

family: Meneveau

full_name: Nathalie Meneveau

given: Nathalie

family: Chatot

full_name: Marion Chatot

given: Marion

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Degano

full_name: Bruno Degano

given: Bruno

family: Bouhaddi

full_name: Malika Bouhaddi

given: Malika

family: Dumoulin

full_name: Gilles Dumoulin

given: Gilles

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Mougin

full_name: Fabienne Mougin

given: Fabienne

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University of Franche-Comté


title: Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children, Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury

acronym: REFECO-OP

summary:
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration.

Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning.

The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles.

It has been shown to be effective in a variety of populations, but has been little explored in children with ABI. The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging, but needs to be confirmed. This study falls within this framework.

Primary objective:

To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.

Maintenance of acquired knowledge
Generalization and transfer
Impact of a consolidation session on generalization and transfer

Secondary objectives:

Gather the experience of family members/caregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions.
Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family members/caregivers.

ReferenceCitation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

ReferenceCitation: Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28. Review.

ReferenceCitation: Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. Epub 2016 Jun 14. Review.

ipd_sharing_description: We think it would be interesting to share the IPD with other researchers (especially Canadian researchers), but we have not yet defined the terms of this sharing.

lead_sponsor: Hopitaux de Saint-Maurice

location_facility: Centre Médical et Pédagogique pour Adolescents


title: A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

acronym: SPARE

summary:
Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years

ReferenceCitation: Hirten RP, Lakatos PL, Halfvarson J, Colombel JF. Reply. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1301-1302. doi: 10.1016/j.cgh.2020.07.061. Epub 2020 Nov 26.

family: Hirten

full_name: Robert P. Hirten

given: Robert P.

family: Lakatos

full_name: Peter L. Lakatos

given: Peter L.

family: Halfvarson

full_name: Jonas Halfvarson

given: Jonas

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

journal_name: Clinical Gastroenterology and Hepatology

title: Reply

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Belgium Australia France

location_facility:
Chu Rennes
Chr Valencienne
Hopital Beaujon
Hopital Saint Joseph
Chu Saint Etienne
St Vincent Hospital
Chu Clermont-Ferrand
Chu Kremlin Bicetre
Hopital Saint Louis
Hopital St Antoine
Chu Nantes
CHU NICE
CHU LYON
Caen Unversity Hospital
Chu Besancon
Chu Lille
Chu Reims
Chu Tours
Gent University Hospital
Chu Montpellier
Montsouris Mutualist Institute
CHU Bordeaux - Pessac
CHU LIEGE - Sart Tilman
Chu Nancy
Chu Amiens
Chu Toulouse
Hopital Bicetre


title: The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

summary:
Elderly cancer patients need more help from their relatives and for longer than young adults.

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.

location_facility:
University hospital, Lille
Centre Oscar Lambret