title: Validation of the French Version of the Geriatric Mental State: a Structured and Standardized Interview for Diagnosis of Psychiatric Disorders in the Elderly

acronym: GMS-Package

summary:
A major public health issues of today's aging population is the development of knowledge and expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and dementia, are among the psychiatric conditions most common in older age. They are the subject of much clinical research, in which brain imaging techniques used to establish correlations anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work locally, is the validation in their French version of clinical assessment tools most commonly used internationally, ensuring reliability, acceptability and comparability of results. Among these tools, "Geriatric Mental Schedule (GMS) Package", is the reference tool for research in psychiatry of the elderly. It is a standardized and structured questionnaire that allows to establish with reliability and reproducibility on the basis of answers to questions, major psychiatric diagnoses in the elderly. It has been validated in several languages (German, Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.

Hypothesis: Validate the the French version of "Geriatric Mental Schedule (GMS) Package", to establish diagnoses of dementia and depressive disorders.

location_facility:
CHU-Limoges- CMRR
University Hospital


title: Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.

acronym: Radioscapho

summary:
The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Central Hospital, Nancy, France

lead_sponsor_type: academique

status_simplified: Completed


title: Influence of Vitamins Status on Severe Obesity Related Complications

acronym: OBESEPI

summary: The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Antoine D, Li Z, Quilliot D, Sirveaux MA, Meyre D, Mangeon A, Brunaud L, Gueant JL, Gueant-Rodriguez RM. Medium term post-bariatric surgery deficit of vitamin B12 is predicted by deficit at time of surgery. Clin Nutr. 2021 Jan;40(1):87-93. doi: 10.1016/j.clnu.2020.04.029. Epub 2020 Apr 25.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Li Z, Gueant-Rodriguez RM, Quilliot D, Sirveaux MA, Meyre D, Gueant JL, Brunaud L. Folate and vitamin B12 status is associated with insulin resistance and metabolic syndrome in morbid obesity. Clin Nutr. 2018 Oct;37(5):1700-1706. doi: 10.1016/j.clnu.2017.07.008. Epub 2017 Jul 24.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: University of Lorraine

sponsor_collaborators:
University of Lorraine
Central Hospital, Nancy, France

intervention_type: Procedure

status_simplified: Ongoing


title: Lung Function Impairment and Postural Spirometry Changes in Ambulatory Myotonic Dystrophy Patients

summary:
Myotonic dystrophy Type 1 (MD1, Steinert's disease), an autosomal dominant multisystem disease, is of the most common muscular dystrophies in adults, with a European prevalence of 3-15/100 000. The disease course is progressive, associating muscular weakness, wasting and myotonia. Respiratory dysfunction is common, involving a restrictive ventilatory abnormality and alveolar hypoventilation, originating from respiratory muscle weakness. Depending on the degree of impairment of their lung function, the quality of life and the prognosis of MD1 patients may be very variable. However, time course and prevalence of such respiratory function impairment have not been clearly identified. More importantly, factors able to predict poor respiratory outcome have not been defined and therefore early prognosis can not be assessed during the follow-up of these patients. In other neuromuscular disorders, especially Amyotrophic Lateral Sclerosis (ALS), postural spirometry has been recommended to improve the detection of diaphragmatic involvement and some authors have suggested that the supine fall in the forced vital capacity could be used to initiate noninvasive positive pressure ventilation and predicts some respiratory symptoms.

In a sample of ambulatory patients with MD1, our study was designed to prospectively achieve two aims: 1) to assess the respective prevalence of a ventilatory restrictive pattern, respiratory muscle weakness, hypoxemia and hypercapnia and 2) to evaluate whether postural changes in lung volumes contribute to sensitize the diagnosis of respiratory weakness and could be used as a predictor of poor respiratory function, including hypoxemia, hypercapnia and restrictive ventilatory disease.

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University of Nancy

sponsor_collaborators:
University of Nancy
Central Hospital, Nancy, France

intervention_type: Other


title: Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

acronym: PEC-Hem

summary:
PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker

lead_sponsor: University Hospital, Bordeaux

collaborators: Ministry for Health and Solidarity, France


acronym: EXPRESS

intervention_type: Drug

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary:
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.

The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France

status: Terminated

title: Open Label Pilot Study on Gene Expression Profiling of the Endometrial Tissue in Patients Undergoing Assisted Reproductive Technology [ART: In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI)] With GONAL-f®

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized

lead_sponsor_type: industriel

status_simplified: Unknown


acronym: ATTAC-PCO

summary: This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).

title: A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART (IVF/ICSI).

type: Other Identifier


title: Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated Over a Period of 3 Years or 5 Years if Applicable, in Comparison With a Historic Cohort of Non-treated Children With Hypochondroplasia

summary: This study is conducted to describe the efficacy and safety of recombinant human growth hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.

ReferenceCitation: Pinto G, Cormier-Daire V, Le Merrer M, Samara-Boustani D, Baujat G, Fresneau L, Viaud M, Souberbielle JC, Pineau JC, Polak M. Efficacy and safety of growth hormone treatment in children with hypochondroplasia: comparison with an historical cohort. Horm Res Paediatr. 2014;82(6):355-63. doi: 10.1159/000364807. Epub 2014 Oct 15.

publisher_dissemination: S. Karger AG

location_facility: Endocrinologie Pédiatrique - centre des maladies rares de la croissance -Hôpital Necker Enfants Malades


title: Obesity and Pregnancy : Study of Factors Influencing Participation in a Program Combining Physical Activity and Nutritional Counseling

acronym: OGAN

summary:
Background:

Obesity increasingly affects young women and contributes to increased maternal, fetal and neonatal complications. Maternal obesity contributes to the subsequent development of childhood obesity not only through social and environmental mechanisms but also through biological processes referring to the original concept of the developmental health and disease. Data suggest that management during pregnancy through nutrition counseling and adequate physical activity will help to break the familial vicious circle of obesity. To help program to be effective it is important to understand the factors that modulate participation. However, few studies have been conducted to assess the determinants that influence participation.

Goal:

The main objective is to analyze 15 factors that influence participation in a program combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25 kg/m2. Secondary objectives are :

to identify the data that influence adherence and to show that assiduous women will have a better control of weight gain and a reduction of maternal and fetal complications.
to understand the biological mechanisms involved

Strategy and method:

A prospective research evaluating the participation in an educational program, including nutritional support and adequate physical activity, will be offered to overweight and obese pregnant women. The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week. Fifteen independent variables likely to influence participation will be analyzed. The association between participation and the risk of maternal and fetal pregnancy complications related to obesity will be analysed. Meanwhile, more fundamental research will be considered to determine of the biological factors involved.

design_allocation: Non-Randomized

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Deruelle P. [Obesity and pregnancy]. Gynecol Obstet Fertil. 2011 Feb;39(2):100-5. doi: 10.1016/j.gyobfe.2010.12.001. Epub 2011 Feb 12. French.

ReferenceCitation: Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
University of Lille Nord de France
Région Nord-Pas de Calais, France

intervention_type: Behavioral


title: A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly

summary:
Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly.

The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.

primary_purpose: Prevention

ReferenceCitation: Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.

lead_sponsor: Association de Recherche Gerontologique

sponsor_collaborators:
Association de Recherche Gerontologique
Conseil Régional d'Aquitaine (France)


title: Qualitative Study of the Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation on the Parental Adjustment of the First Year

acronym: INEMAT

summary: Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.

primary_purpose: Other

sponsor_collaborators:
University Hospital, Lille
University of Lille Nord de France


title: Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.

acronym: GABATHOMIE

summary: To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.

ipd_sharing: No

location_facility: Department of Thoracic Surgery, Lille University Hospital


title: Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock

acronym: Hyperdia

summary:
Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of patients after resuscitation for cardiac arrest. This acute circulatory insufficiency presents similar characteristics with septic shock and is responsible of most early deaths. Most frequently, usual treatments are unable to control this shock and to avoid the appearance of multiple organ failure.

Aim of the study: In addition to conventional therapeutics, an early plasma epuration of inflammatory mediators (HDHP) could be able to improve hemodynamic parameters and to reduce the shock duration. This improvement could have an impact on multiple organ dysfunctions and also on early mortality.

ReferenceType: result

ReferenceCitation: Geri G, Grimaldi D, Seguin T, Lamhaut L, Marin N, Chiche JD, Pene F, Bougle A, Daviaud F, Morichau-Beauchant T, Arnaout M, Champigneulle B, Zafrani L, Bourcier S, Nguyen YL, Charpentier J, Mira JP, Coste J, Vinsonneau C, Cariou A. Hemodynamic efficiency of hemodialysis treatment with high cut-off membrane during the early period of post-resuscitation shock: The HYPERDIA trial. Resuscitation. 2019 Jul;140:170-177. doi: 10.1016/j.resuscitation.2019.03.045. Epub 2019 Apr 8.

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

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

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Gambro Industries, MEYZIEU, France

location_facility: Medical intensive care unit of Cochin-St Vincent de Paul university Hospital

intervention_type: Device


title: Functionnal Magnetic Resonnance Imaging (fMRI)Study of Cerebral Substrates of New Musical and Pictorial Learning in Alzheimer Patients

acronym: INCAS

summary:
This research attempts to better understand the altered and preserved memory mechanisms in Alzheimer disease, particularly to better apprehend learning implicit memory processes, and give a scientific support to non-pharmalogical interventions. At the present time, it is possible to delay the emergence of the symptoms related to this disease, eventually to decrease it, but not to cure it. Yet, care these patients became a crucial question and the solutions proposed to healthy aging people are not appropriate for Alzheimer patients who present specific disorders. The improvement of the quality of life of the institutionalized patients lies on a better comprehension of their disorders but also of their preserved abilities. The literature testifies of a great heterogeneity in the clinical expression of this disease, however we noticed two constants with regard to the capabilities generally announced as being preserved, on one hand, the implicit memory, and on the other hand the artistic aptitudes, and more particularly musical capabilities.

Patients with Alzheimer disease present a particularly severe and early deterioration of episodic memory. Thus, at the beginning of the disease the explicit acquisition of new knowledge becomes increasingly difficult. However, some clinical observations, such as new learning of unknown songs, even with patients at a severe stage of the illness, seem to support the assumption of a preservation of some implicit learning abilities. Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly at the beginning stage of the illness: preserved effects of perceptual priming, procedural learning. Thus, we are mainly interested by the effects of exposure and the rising of a feeling of familiarity, both showing preserved implicit learning abilities, for moderate to severe Alzheimer patients. However, no study was carried out to date using the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of illness, with the main objective to identify the cerebral substrates implied in the learning of new knowledge.

Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly were performed at the beginning stage of the illness and none of them have studied theses learning abilities for moderate to severe Alzheimer patients.

The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to highlight neural networks underlying this learning process (recently learned stimuli vs old stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding which cognitive mechanisms and cerebral areas allow these learning capabilities.

20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage of the illness, and 20 healthy aging participants, are selected after a neurological interview and a neuropsychological evaluation. The whole of the included participants take part of the experimental protocol organized in two phases: - the phase of familiarization and the phase of test. The phase of familiarization consists of the repeated exposure (daily session before the MRI acquisition) of new songs and new painting until obtaining a high feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera, it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional acquisition corresponds to a passive listening and seeing tasks of musical and pictorial stimuli. Finally, all participants realize a debriefing phase that allows obtaining a feedback on the familiarity of stimuli presented during the functional acquisition.

status: Unknown status

lead_sponsor: University Hospital, Caen

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


title: From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations

acronym: ALCOBRAIN

summary: This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.

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


title: Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients

acronym: LUNG-RESIST

summary: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) are effective therapies for advanced lung cancer patients bearing EGFR-activating mutations, but are not curative due to the invariable apparition of resistances. The investigator team have identified a new phenotype related to drug tolerance after EGFR-TKI treatment that shares several characteristics of a known process of Therapy-Induced Senescence (TIS), which could be a major event of drug tolerance in patients. Using cutting-edge technologies, patient-derived xenografts (PDX) and circulating tumor cells (CTC), the investigator team will perform an exhaustive characterization of the phenotypic and molecular changes associated with this drug-tolerant state in patients. Their results should lead to new therapeutic approaches to eliminate the reservoir of drug-tolerant cells and to prevent emergence of resistance mutations responsible for the relapse of patients.

lead_sponsor: University Hospital, Toulouse


title: Estimation of Cardiac Output in the Operating Room by Pulse Wave Analysis and Esophageal Doppler Blood Velocity: Comparison of the Two Methods

acronym: TRIPLEFLOW

summary: During major surgery, it is recommended to monitor invasive arterial blood pressure and cardiac output (CO) during hemodynamic interventions (fluid challenge or vasopressors). Esophageal Doppler is currently considered as the reference method for monitoring cardiac output in the operating room. The PRAM method (pressure recording analytical method) with the MostCareUp monitor (Vytech, Padova, Italy) and the LTIA method (long time interval analysis) allow cardiac output estimation derived from non-calibrated arterial pressure waveform analysis. Few studies have looked at relative changes in cardiac output during hemodynamic intervention with these two methods. The aim of this study is to compare the relative changes in cardiac output during hemodynamic interventions as measured using PRAM and LTIA methods, compared to esophageal Doppler.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM UMR-942, Paris, France

location_facility: AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care


title: Study of the Efficacy of Propranolol for the Management of Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

acronym: EPERO

summary: Hereditary Hemorrhagic Telangiectasia (HHT) is a genetic disorder of angiogenesis associated with disabling epistaxis. Management of these nose bleedings requires more effective treatment. Propranolol, a beta-blocker, is a potentially useful therapeutic considering its anti-angiogenic properties. Our objective is to explore the efficacy of propranolol, three months after its introduction, on the cumulative duration of epistaxis in HHT patients.

collaborators: AMRO-HHT-France - Association Maladie de Rendu-Osler

location_facility: CHU de Bordeaux - service de médecine interne


title: Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients

summary: The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.

ReferenceCitation: Roberts MM, Cho JG, Sandoz JS, Wheatley JR. Oxygen desaturation and adverse events during 6-min walk testing in patients with COPD. Respirology. 2015 Apr;20(3):419-25. doi: 10.1111/resp.12471. Epub 2015 Jan 20.

publisher_dissemination: Wiley

ReferenceCitation: Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013 Feb 15;187(4):382-6. doi: 10.1164/rccm.201209-1596OC. Epub 2012 Dec 21.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

evidence: open (via free pdf)

license_normalized: no license

repository_institution: UHasselt - Document Server@UHasselt

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ipd_sharing: Yes

lead_sponsor: Centre Hospitalier des Pays de Morlaix

collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain


acronym: Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC

lead_sponsor: Dr. Falk Pharma GmbH

summary: The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at risk for disease progression. It is assumed that the combination therapy will result in a decrease of treatment failures after 3 years of treatment.

ReferenceCitation: Hirschfield GM, Beuers U, Kupcinskas L, Ott P, Bergquist A, Farkkila M, Manns MP, Pares A, Spengler U, Stiess M, Greinwald R, Prols M, Wendum D, Drebber U, Poupon R. A placebo-controlled randomised trial of budesonide for PBC following an insufficient response to UDCA. J Hepatol. 2021 Feb;74(2):321-329. doi: 10.1016/j.jhep.2020.09.011. Epub 2020 Sep 17.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Helsinki - Helda

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories_concat: HELDA - Digital Repository of the University of Helsinki;Pure (Denmark)

repositories_institution:
Elsevier - Scopus
University of Helsinki - Helda

ReferenceCitation: Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29.

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: Informa

location_facility:
Universitätsklinikum Bonn
Hôpital Saint-Antoine

title: Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study Comparing the Combination of Ursodeoxycholic Acid Capsules Plus Budesonide Capsules to Ursodeoxycholic Acid Capsules Plus Placebo in the Treatment of Primary Biliary Cirrhosis

location_country: Germany France


title: Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

acronym: Epi-FaR

summary: The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

primary_purpose: Basic Science

ReferenceCitation: Bragin A, Wilson CL, Staba RJ, Reddick M, Fried I, Engel J Jr. Interictal high-frequency oscillations (80-500 Hz) in the human epileptic brain: entorhinal cortex. Ann Neurol. 2002 Oct;52(4):407-15. doi: 10.1002/ana.10291.

ReferenceCitation: Crepon B, Navarro V, Hasboun D, Clemenceau S, Martinerie J, Baulac M, Adam C, Le Van Quyen M. Mapping interictal oscillations greater than 200 Hz recorded with intracranial macroelectrodes in human epilepsy. Brain. 2010 Jan;133(Pt 1):33-45. doi: 10.1093/brain/awp277. Epub 2009 Nov 17.

ReferenceCitation: Demont-Guignard S, Benquet P, Gerber U, Biraben A, Martin B, Wendling F. Distinct hyperexcitability mechanisms underlie fast ripples and epileptic spikes. Ann Neurol. 2012 Mar;71(3):342-52. doi: 10.1002/ana.22610.

ReferenceCitation: Jacobs J, Levan P, Chatillon CE, Olivier A, Dubeau F, Gotman J. High frequency oscillations in intracranial EEGs mark epileptogenicity rather than lesion type. Brain. 2009 Apr;132(Pt 4):1022-37. doi: 10.1093/brain/awn351. Epub 2009 Mar 18.

ReferenceCitation: Jacobs J, Zijlmans M, Zelmann R, Chatillon CE, Hall J, Olivier A, Dubeau F, Gotman J. High-frequency electroencephalographic oscillations correlate with outcome of epilepsy surgery. Ann Neurol. 2010 Feb;67(2):209-20. doi: 10.1002/ana.21847.

ReferenceCitation: Staba RJ, Frighetto L, Behnke EJ, Mathern GW, Fields T, Bragin A, Ogren J, Fried I, Wilson CL, Engel J Jr. Increased fast ripple to ripple ratios correlate with reduced hippocampal volumes and neuron loss in temporal lobe epilepsy patients. Epilepsia. 2007 Nov;48(11):2130-8. doi: 10.1111/j.1528-1167.2007.01225.x. Epub 2007 Jul 28.

ReferenceCitation: Worrell GA, Gardner AB, Stead SM, Hu S, Goerss S, Cascino GJ, Meyer FB, Marsh R, Litt B. High-frequency oscillations in human temporal lobe: simultaneous microwire and clinical macroelectrode recordings. Brain. 2008 Apr;131(Pt 4):928-37. doi: 10.1093/brain/awn006. Epub 2008 Feb 7.

ReferenceCitation: Zijlmans M, Jiruska P, Zelmann R, Leijten FS, Jefferys JG, Gotman J. High-frequency oscillations as a new biomarker in epilepsy. Ann Neurol. 2012 Feb;71(2):169-78. doi: 10.1002/ana.22548.

collaborators: CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France


title: Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea

summary: The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

ReferenceCitation: Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: Safety of Targeted Therapies in Elderly Patients (Over 5 and 75 Year-old) With Metastatic Melanoma

acronym: TOLBRIPA

summary: Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients

sponsor_collaborators:
University Hospital, Montpellier
Saint-Louis Hospital, Paris, France


title: Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples: Prospective Multicenter Study in Primary Care

summary: Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Groupe Hospitalier Diaconesses Croix Saint-Simon

collaborators: Association Clinique Thérapeutique Infantile du val de Marne

intervention_type: Diagnostic Test

appel_a_projets: RESPIR

region: Île-de-France

nom_etablissement: HOPITAL FONDATION A DE ROTHSCHILD

type_etablissement: EBNL

acronyme: PREDISTREP-IX

titre: Performances des tests moléculaires rapides sur salive pour le diagnostic d'angine à streptocoque du groupe A chez l'enfant en soins primaires

discipline_principale: autre

nom_porteur: COHEN

prenom_porteur: Jérémie


title: Pilot Phase of a Prospective Cohort of Patients With Alzheimer's Disease and Their Families

summary: This is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. The family clusters will be followed-up in expert memory centers and online in order to study risk and prognostic factors (including blood-based biomarkers) in the first-degree relatives and patients, respectively, as well as caregiver health, difficulties and needs. This pilot study is performed to assess the feasibility of conducting a larger-scale study.

sponsor_collaborators:
University Hospital, Toulouse
France Alzheimer

location_facility:
CMRR Centre de Rouen
CMRR Centre de Montpellier
CMRR - CRC Centre de Toulouse


title: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe

summary: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

ReferenceCitation: Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Betard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17.

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

lead_sponsor: Janssen Vaccines & Prevention B.V.

location_country:
United Kingdom
France

intervention_type: Biological


title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial

acronym: Bari-SolidAct

summary: EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.

ReferenceCitation: Troseid M, Arribas JR, Assoumou L, Holten AR, Poissy J, Terzic V, Mazzaferri F, Bano JR, Eustace J, Hites M, Joannidis M, Paiva JA, Reuter J, Puntmann I, Patrick-Brown TDJH, Westerheim E, Nezvalova-Henriksen K, Beniguel L, Dahl TB, Bouscambert M, Halanova M, Peterfi Z, Tsiodras S, Rezek M, Briel M, Unal S, Schlegel M, Ader F, Lacombe K, Amdal CD, Rodrigues S, Tonby K, Gaudet A, Heggelund L, Mootien J, Johannessen A, Moller JH, Pollan BD, Tveita AA, Kildal AB, Richard JC, Dalgard O, Simensen VC, Balde A, de Gastines L, Del Alamo M, Aydin B, Lund-Johansen F, Trabaud MA, Diallo A, Halvorsen B, Rottingen JA, Tacconelli E, Yazdanpanah Y, Olsen IC, Costagliola D; EU SolidAct study group. Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial. Crit Care. 2023 Jan 10;27(1):9. doi: 10.1186/s13054-022-04205-8.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Oslo - Duo Research Archive

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

ipd_sharing_description: Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants. Anonymized data will be made publicly available using a data repository, including any programming code used to produce the trial results. De-identified data will be made available upon request and evaluation of the requestee's ability and willingness to maintain the integrity and privacy of the trial participants. Further details of data sharing will be given in a separate data sharing plan.

lead_sponsor: Oslo University Hospital

collaborators: Epidemiological and Clinical Research Information Network

location_country: Germany Ireland Italy Portugal Slovakia Hungary Norway Austria Belgium Spain Luxembourg Greece Turkey Czechia France

location_facility: Ospedale Santa Maria Annunziata, Malattie Infettive

location_facility: University of Debrecen (Clinic for Infectology)

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra

location_facility: CHLN - Centro Hospitalar Universitário Lisboa Norte

location_facility: CHMT - Centro Hospitalar do Médio Tejo- Hospital de Abrantes

location_facility: Hopital de la Croix - Rousse - HCL (ICU)

location_facility: CHU Lille - Hopital Roger Salengro -Pôle Rèanimaition

location_facility: Ospedale S.M. Goretti di Latina, U.O.C. Malattie Infettive

location_facility: Ospedale Mater Salutis di Legnago, U.O.S. di Malattie Infettive

location_facility: Azienda Opsedaliera Universitaria Mater Domini, U.O. Malattie Infettive e Tropicali

location_facility: Azienda Ospedaliera Universitaria Vanvitelli, U.O.C. Malattie Infettive

location_facility: ATS Sardegna - PO SS Trinità, U.O.C. Malattie Infettive

location_facility: Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 1)

location_facility: Medical University of Innsbruck (University Hospital for Neurosurgery)

location_facility: CHU de Bordeaux / Hopital Pellegrin (ID)

location_facility: CHLO - Centro Hospitalar de Lisboa Ocidental - HEM and HSFX

location_facility: ASST Santi Paolo e Carlo, S.C. Malattie Infettive

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria, U.O.S. Malattie Infettive e Tropicali

location_facility: CHLC-HCC - Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central

location_facility: Ospedale Mater Salutis di Legnago, U.O.C. di Pneumologia

location_facility: Ankara Üniversitesi Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: Medical Unversity of Innsbruck (University Hospital for Anaesthesia and Intensive Care)

location_facility: ASL Frosinone - Ospedale Fabrizio Spaziani, U.O.C. Medicina Interna

location_facility: İstanbul Üniversitesi İstanbul Tıp Fakültesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: CHUA-Faro - Centro Hospitalar Universitário do Algarve

location_facility: Medical Unversity of Innsbruck (Joint Institute for Emergency Medicine and Critical Care)

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), S.C. Malattie Infettive

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord, U.O.C. Malattie Infettive

location_facility: AOU Policlinico "P. Giaccone", U.O.C. Malattie Infettive

location_facility: Technische Universität München (TUM) - Klinikum rechts der Isar

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona, U.O.C. Malattie Infettive e Tropicali

location_facility: ASST - Spedali Civili di Brescia - University of Brescia

location_facility: AOU Città della Salute e Scienza Presidio Molinette

location_facility: ASL Taranto - Ospedale Oncologico San Giuseppe Moscati, U.O.C. Pneumologia

location_facility: CHU de Bordeaux / Hopital Pellegrin (ICU)

location_facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı

location_facility: Hacettepe Üniversitesi Tıp Fakültesi, İnfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Anabilim Dalı (Site 2)


title: Exploitation of a BAse of Genetic Data (Obtained by Next Generation SEquencing) for the Validation of a Clinical Algorithm for the Diagnosis of Recessive Cerebellar Ataxias

acronym: BASE-AAR

summary:
The field of clinical diagnosis of recessive cerebellar ataxias (ARCA) is particularly complex and Next Generation Sequencing (NGS) techniques have revolutionized this neuro-genetic field. The current challenge is to optimize the analysis of genetic data generated by NGS because: the processing of data remains very laborious; diagnostic yeld less than 50%; the interpretation of the variants sometimes very difficult. For this purpose of optimization, the team of the University Hospital of Strasbourg has developed a computer algorithm based on 124 clinical and para-clinical parameters (derived from the data of the literature), useful to guide the genes to be targeted in priority by genetic analysis, in the context of a suspicion of ARCA (> 60 known genes); this algorithm was validated retrospectively in 834 patients with genetically confirmed ARCA (92% Sense, 95% Spec). However, these 834 patients are often the same as those described in the literature and used for the elaboration of the algorithm. This introduces a bias in the initial evaluation of the algorithm, which therefore requires validation in clinical practice, from a cohort of patients referred for suspected ARCA (with or without a found genetic mutation). At the same time, Montpellier's genetics laboratory has developed a bioinformatic method for the search for copy number variations (CNV) that can be applied in a targeted manner to the genes predicted by the algorithm.

The principal aim of this study is the validation of a semi-automated clinical algorithm for NGS molecular diagnosis of ARCA; the secondary objective is to evaluate if the application of this algorithm coupled with a targeted bioinformatic analysis can increase the diagnostic yield of the NGS analysis.

ipd_sharing_description: NC

collaborators: Neurology Department, CHU de Strasbourg-France

collaborators: Genetic Department , CHU Montpellier-France


title: Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

acronym: EMSICA

summary: The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.

ReferenceCitation: Labrunee M, Despas F, Marque P, Guiraud T, Galinier M, Senard JM, Pathak A. Acute electromyostimulation decreases muscle sympathetic nerve activity in patients with advanced chronic heart failure (EMSICA Study). PLoS One. 2013 Nov 12;8(11):e79438. doi: 10.1371/journal.pone.0079438. eCollection 2013.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

collaborators: Foundation for the Future, Paris, France


title: Psychological Levers of Commitment and Persistence in Physical Activity in People With Type 2 Diabetes. PerPA2Temps Study

summary: Many programmes exist to enable patients to engage in physical activity, but it is clear that the objectives are often not achieved in terms of quality, quantity or intensity of practice. In this study, the aim is to find alternatives, assuming that strengthening patients' self-efficacy, meeting their basic needs and increasing their level of hope will have an impact on their motivation to practice, which in turn will have an impact on their actual practice. The aim is to develop and implement an innovative intervention programme and to identify the interactions between the variables that are assumed to predict engagement in practice.

status: Active, not recruiting

lead_sponsor: Siel Bleu


title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

summary:
The purposes of the study are:

To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.

ReferenceCitation: Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.

lead_sponsor: Maternite Regionale Universitaire


title: Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study

acronym: ACLSTIFF

summary:
The role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. However, little is known about the passive hamstring stiffness after ACL reconstruction (ACLR).

The primary objective of this study is to evaluate the passive stiffness of hamstring muscles after ACLR by using an isokinetic device. Secondary, we aimed to test the individual and surgical characteristics associated with hamstring stiffness and the impact of hamstring stiffness on RTS and knee re-injury.

The hypotheses are that hamstring stiffness will be lower in the ACLR leg compared to the uninjured leg and to healthy individuals.

Also, we hypothesized that hamstring stiffness will be lower after hamstring autograft compared to patellar tendon autograft and will increase progressively after ACLR to be symmetrical at the time for RTS.

Also, we hypothesized that hamstring stiffness could be associated with better outcomes at RTS (RTS at same level and lower re-injury rates)

collaborators: INSERM U1075 COMETE, UNICAEN, Caen France


title: Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device

acronym: ISOSTIFF

summary: The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity

sponsor_collaborators: INSERM U1075 COMETE, UNICAEN, Caen France


title: Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

acronym: PREDICT-ACL

summary:
Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.

challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.

ReferenceCitation: Drigny J, Ferrandez C, Gauthier A, Guermont H, Praz C, Reboursiere E, Hulet C. Knee strength symmetry at 4 months is associated with criteria and rates of return to sport after anterior cruciate ligament reconstruction. Ann Phys Rehabil Med. 2022 Jun;65(4):101646. doi: 10.1016/j.rehab.2022.101646. Epub 2022 Apr 30.

oa_host_type: publisher


title: Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis

acronym: HSMDP

summary: The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event

status: Withdrawn

ReferenceCitation: Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

collaborators: Agence Regionale de Sante d'Ile de France


title: Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures

acronym: SSRHAD

summary: The objective of this study is to assess the medical and economic relevance of teleconsulting for Rehabilitation After Hip and Knee Surgical Procedures.

ReferenceCitation: Tubach F, Baron G, Falissard B, Logeart I, Dougados M, Bellamy N, Ravaud P. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005 Jan;64(1):75-9. doi: 10.1136/ard.2003.019539.

ReferenceCitation: Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.

ReferenceCitation: Baron G, Tubach F, Ravaud P, Logeart I, Dougados M. Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis. Arthritis Rheum. 2007 May 15;57(4):633-8. doi: 10.1002/art.22685.

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

repositories_concat: PubMed Central

sponsor_collaborators: Agence Regionale de Sante d'Ile de France

location_facility: Fondation Santé Service, Pôle Rééducation- Handicap


title: Comparison of Efficacy of an Outpatient vs Inpatient Detoxification Program for Alcohol Dependent Patients Seeking Abstinence. A Prospective Randomized Clinical Trial.

summary: Detoxification, in an inpatient or outpatient program, is the primary and essential step for managing alcohol dependence. The superiority of one or other method of detoxification has never been proved in several previous randomized clinical trials (RCT). The aim of this multicenter RCT was to compare efficiency, on the abstinence rate as the primary outcome, at 1 and 3 months follow-up of two alcohol detoxification programs (a 5/7-days inpatient detox vs. an ambulatory detox).

ReferenceCitation: Limosin F, Romo L, Batel P, Ades J, Boni C, Gorwood P. Association between dopamine receptor D3 gene BalI polymorphism and cognitive impulsiveness in alcohol-dependent men. Eur Psychiatry. 2005 May;20(3):304-6. doi: 10.1016/j.eurpsy.2005.02.004.

ReferenceCitation: Batel P, Reynaud-Maurupt C, Lavignasse P, Constant MV, Kopp P, Jourdain JJ, Videau B, Mucchielli A, Riff B, Lowenstein W. [Risk factors of early drop-out during induction of high-dose buprenorphine substitution therapy. A study of 1085 opiate addicts]. Presse Med. 2004 Oct 23;33(18 Suppl):5-9. doi: 10.1016/s0755-4982(04)72375-1. French.

ReferenceCitation: Batel P, Balester-Mouret S. [Care network in addictive pathologies: where is it?]. Rev Prat. 2003 Jun 15;53(12):1335-9. French.

ReferenceCitation: Pessione F, Ramond MJ, Peters L, Pham BN, Batel P, Rueff B, Valla DC. Five-year survival predictive factors in patients with excessive alcohol intake and cirrhosis. Effect of alcoholic hepatitis, smoking and abstinence. Liver Int. 2003 Feb;23(1):45-53. doi: 10.1034/j.1600-0676.2003.01804.x.

ReferenceCitation: Gorwood P, Limosin F, Batel P, Hamon M, Ades J, Boni C. The A9 allele of the dopamine transporter gene is associated with delirium tremens and alcohol-withdrawal seizure. Biol Psychiatry. 2003 Jan 1;53(1):85-92. doi: 10.1016/s0006-3223(02)01440-3.

ReferenceCitation: Lavignasse P, Lowenstein W, Batel P, Constant MV, Jourdain JJ, Kopp P, Reynaud-Maurupt C, Riff B, Videau B, Mucchielli A. Economic and social effects of high-dose buprenorphine substitution therapy. Six-month results. Ann Med Interne (Paris). 2002 May;153(3 Suppl):1S20-6.

ReferenceCitation: Batel P, Michaud P. [Risky alcohol drinking or problems and brief interventions]. Gastroenterol Clin Biol. 2002 May;26(5 Suppl):B158-62. No abstract available. French.

ReferenceCitation: Gorwood P, Aissi F, Batel P, Ades J, Cohen-Salmon C, Hamon M, Boni C, Lanfumey L. Reappraisal of the serotonin 5-HT(1B) receptor gene in alcoholism: of mice and men. Brain Res Bull. 2002 Jan 1;57(1):103-7. doi: 10.1016/s0361-9230(01)00641-4.

ReferenceCitation: Gorwood P, Limosin F, Batel P, Duaux E, Gouya L, Ades J. The genetics of addiction: alcohol-dependence and D3 dopamine receptor gene. Pathol Biol (Paris). 2001 Nov;49(9):710-7. doi: 10.1016/s0369-8114(01)00236-x.

ReferenceCitation: Batel P, Lariviere P. [Late-onset alcohol withdrawal syndrome]. Ann Med Interne (Paris). 2000 Oct;151 Suppl B:B27-9. French.

ReferenceCitation: Gorwood P, Batel P, Ades J, Hamon M, Boni C. Serotonin transporter gene polymorphisms, alcoholism, and suicidal behavior. Biol Psychiatry. 2000 Aug 15;48(4):259-64. doi: 10.1016/s0006-3223(00)00840-4.

ReferenceCitation: Batel P. Addiction and schizophrenia. Eur Psychiatry. 2000 Mar;15(2):115-22. doi: 10.1016/s0924-9338(00)00203-0.

ReferenceCitation: Gorwood P, Batel P, Gouya L, Courtois F, Feingold J, Ades J. Reappraisal of the association between the DRD2 gene, alcoholism and addiction. Eur Psychiatry. 2000 Mar;15(2):90-6. doi: 10.1016/s0924-9338(00)00207-8.

ReferenceCitation: Batel P. [Alcohol withdrawal syndrome in the hospital]. Rev Prat. 1999 Feb 15;49(4):387-90. French.

ReferenceCitation: Quinones-Jenab V, Batel P, Schlussman SD, Ho A, Kreek MJ. Cocaine impairs maternal nest building in pregnant rats. Pharmacol Biochem Behav. 1997 Dec;58(4):1009-13. doi: 10.1016/s0091-3057(97)00311-0.

ReferenceCitation: Batel-Copel LM, Kornblith AB, Batel PC, Holland JC. Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer. 1997 Jan;33(1):29-32. doi: 10.1016/s0959-8049(96)00414-5.

ReferenceCitation: Batel P. A critique of chapter 3: "Individual drinking and degree of risk". Addiction. 1995 Nov;90(11):1450-1. doi: 10.1111/j.1360-0443.1995.tb02804.x. No abstract available.

ReferenceCitation: Batel P. The treatment of alcoholism in France. Drug Alcohol Depend. 1995 Sep;39 Suppl 1:S15-21. doi: 10.1016/0376-8716(95)01169-y.

ReferenceCitation: Batel P, Pessione F, Maitre C, Rueff B. Relationship between alcohol and tobacco dependencies among alcoholics who smoke. Addiction. 1995 Jul;90(7):977-80. doi: 10.1046/j.1360-0443.1995.90797711.x.

ReferenceCitation: Batel P, Pessione F, Bouvier AM, Rueff B. Prompting alcoholics to be referred to an alcohol clinic: the effectiveness of a simple letter. Addiction. 1995 Jun;90(6):811-4. doi: 10.1046/j.1360-0443.1995.9068118.x.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Direction Générale de la Santé, France


title: Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer

summary:
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical tolerance of PA0903 as root canal sealer

SPONSOR:

SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 11/001

PRODUCT NAME: PA0903

MEDICAL DEVICE:

Class III: Root canal sealer Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

lead_sponsor: Ascopharm Groupe Novasco

location_facility: Cabinet dentaire privé - 21, rue Fabre d'Églantine

location_facility: Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière


title: Contribution of Anti-platelet Antibodies Identified With" Monoclonal Antibody Immobilization of Platelet Antigens" Assay (MAIPA) in the Demonstration of the Auto-immune Character of a Thrombocytopenia at Diagnosis

acronym: APAT

summary: Immune thrombocytopenia (ITP) is an autoimmune disease but, paradoxically, and unlike other autoimmune diseases, antiplatelet antibodies are not used either for the diagnosis of the disease or for its prognosis. ITP is a diagnosis of exclusion retained after elimination of other pathologies leading to a thrombocytopenia. No major study has prospectively evaluated the diagnostic value of the presence of anti-platelet antibodies in the etiological investigation of a thrombocytopenia, nor the impact of platelet antibodies on the course of ITP. The gold standard analysis for the determination of platelet antibodies, is the "monoclonal antibody immobilization of platelet antigens" assay (MAIPA), either direct to detect autoantibodies attached to platelets, or indirect to detect circulating antiplatelet antibodies. Therefore, this work aims to study the contribution of the presence of anti-platelet antibodies detected in MAIPA to determine the autoimmune nature of a thrombocytopenia at diagnosis.

sponsor_collaborators: Ministry for Health and Solidarity, France

location_facility: CHU de Bordeaux - service de médecine interne


title: Multimodal Remote Monitoring and Integrated Educational Program in OSA Patients Initiating Continuous Positive Airway Pressure (CPAP): a Prospective Intervention (SLEEPCONNECT)

acronym: SLEEPCONNECT

summary:
Continuous positive airway pressure (CPAP) is the first line therapy for Obstructive Sleep Apnea Syndrome (OSAS) but has limited impact for reducing cardio-metabolic risk.

Combined treatment strategies including physical activity and weight loss management have emerged in association with CPAP. Patient's engagement might be supported by connected devices and smartphone applications measuring physical activity, blood pressure, weight and sleep duration. Data fusion of these parameters with CPAP-remote telemonitoring will allow personalized coaching and integrated care of OSAS with cardio-metabolic co-morbidities.

ReferenceCitation: Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.

ReferenceCitation: Malhotra A, Orr JE, Owens RL. On the cutting edge of obstructive sleep apnoea: where next? Lancet Respir Med. 2015 May;3(5):397-403. doi: 10.1016/S2213-2600(15)00051-X. Epub 2015 Apr 14.

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Arnaud C, Dematteis M, Pepin JL, Baguet JP, Levy P. Obstructive sleep apnea, immuno-inflammation, and atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):113-25. doi: 10.1007/s00281-009-0148-5. Epub 2009 Apr 29.

ReferenceCitation: Aron-Wisnewsky J, Clement K, Pepin JL. Nonalcoholic fatty liver disease and obstructive sleep apnea. Metabolism. 2016 Aug;65(8):1124-35. doi: 10.1016/j.metabol.2016.05.004. Epub 2016 May 13.

ReferenceCitation: McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

ReferenceCitation: Jullian-Desayes I, Joyeux-Faure M, Tamisier R, Launois S, Borel AL, Levy P, Pepin JL. Impact of obstructive sleep apnea treatment by continuous positive airway pressure on cardiometabolic biomarkers: a systematic review from sham CPAP randomized controlled trials. Sleep Med Rev. 2015 Jun;21:23-38. doi: 10.1016/j.smrv.2014.07.004. Epub 2014 Jul 31.

ReferenceCitation: Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.

ReferenceCitation: Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

ReferenceCitation: Chirinos JA, Gurubhagavatula I, Teff K, Rader DJ, Wadden TA, Townsend R, Foster GD, Maislin G, Saif H, Broderick P, Chittams J, Hanlon AL, Pack AI. CPAP, weight loss, or both for obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2265-75. doi: 10.1056/NEJMoa1306187.

ReferenceCitation: Schwab RJ, Badr SM, Epstein LJ, Gay PC, Gozal D, Kohler M, Levy P, Malhotra A, Phillips BA, Rosen IM, Strohl KP, Strollo PJ, Weaver EM, Weaver TE; ATS Subcommittee on CPAP Adherence Tracking Systems. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013 Sep 1;188(5):613-20. doi: 10.1164/rccm.201307-1282ST.

ReferenceCitation: Redline S, Dean D 3rd, Sanders MH. Entering the era of "big data": getting our metrics right. Sleep. 2013 Apr 1;36(4):465-9. doi: 10.5665/sleep.2524. No abstract available.

ReferenceCitation: Hwang D. Monitoring Progress and Adherence with Positive Airway Pressure Therapy for Obstructive Sleep Apnea: The Roles of Telemedicine and Mobile Health Applications. Sleep Med Clin. 2016 Jun;11(2):161-71. doi: 10.1016/j.jsmc.2016.01.008. Epub 2016 Mar 26.

lead_sponsor: University Hospital, Grenoble

collaborators: SEFAM MEDICAL (Villiers les Nancy, France)


title: Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia

acronym: BIOCAI

summary: The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.

lead_sponsor: University Hospital, Bordeaux


title: Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.

summary:
Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.

We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).

ReferenceCitation: Contenti J, Corraze H, Lemoel F, Levraut J. Effectiveness of arterial, venous, and capillary blood lactate as a sepsis triage tool in ED patients. Am J Emerg Med. 2015 Feb;33(2):167-72. doi: 10.1016/j.ajem.2014.11.003.

lead_sponsor: Hopital Saint Roch


title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone

summary: The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

lead_sponsor: Galderma R&D

location_country: Sweden France

location_facility:
Akademikliniken
Mediti Center
Centre Medical Saint-Jean


title: Acute Effect of a Standardized Botanical Blend Rich in Polyphenols on Cognitive Functions in Healthy Students: Randomized, Placebo-controlled, Double-blind, Cross-over Clinical Trial

summary:
Available literature suggests that flavanols-rich foods, and more especially monomeric flavanols-rich foods such as grape, can have an acute effect on cognitive functions via different mechanisms such as cerebral blood flow improvement.

The objective of this study is to investigate the effect of a Standardized botanical blend rich in polyphenols (SBRP), on cognitive functions, together with endothelial function in healthy students. Moreover, in order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.

The study design will be a double-blind, randomised, placebo controlled, crossover study. A total of 30 healthy volunteers will be included. Each participant will receive a single dose of SBRP and placebo capsules, during 2 separate experimental visits and in a counterbalanced order. There will be a 1 week washout period between the 2 experimental visits. During each experimental visit, after a training battery volunteers will be administered a cognitive test battery (COMPASS) before product intake and 6 times after product intake (B1 to B6, from 90 min post-dose to 160 min post-dose).

lead_sponsor: Activ'inside

collaborators: CIC SANPSY (USR CNRS 3413), Hôpital Pellegrin, Bordeaux, FRANCE

intervention_type: Dietary Supplement


title: Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers

summary: The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.

ReferenceCitation: Campeotto F, Waligora-Dupriet AJ, Doucet-Populaire F, Kalach N, Dupont C, Butel MJ. [Establishment of the intestinal microflora in neonates]. Gastroenterol Clin Biol. 2007 May;31(5):533-42. doi: 10.1016/s0399-8320(07)89424-3. French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Blédina SA, Villefranche sur Saône, France

location_facility: Neonatat unit, Saint Vincent de Paul Hospital


title: Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction

acronym: MATISSE

summary: The MATISSE (Molecular Analysis of Thrombus for Ischemic Stroke prognosis and Etiology) project evaluates the hypothesis that the molecular composition of cerebral thrombus in metabolites, lipids, and proteins conditions the clinical prognosis at 3 months of the infarction and informs on its etiological subtype

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHU La Réunion
Stroke Center
CHU Martinique


title: Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care Unit

acronym: FLY-MICU

summary: Patient care who requires fast and intensive care by a mobile intensive care unit in a rescue helicopter is a common practice in Auvergne since more than 3 years. Indeed, a complete team (nurse and emergency physician) is on Dragon 63 and HeliSMUR 63 (SMUR = emergency medical services ). There are multiple fields of action, with a primary rescue activity (patient care directly at the site of the operation) but also secondary transport (transfer of patients from one hospital to another). This allows a reduction in transport time and therefore unavailability of the MICU team in general hospitals, which are in short supply of attending physicians. In addition, this allows patients to be repatriated to the Clermont-Ferrand University Hospital Center, which is the reference center for many pathologies and has the Level 3 adult and pediatric Trauma Center.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France


title: National Cohort on the Vascular Ehlers-Danlos Syndrome (SEDv)

summary: The goal of this observational study is to describe the natural course of vascular Ehlers-Danlos syndrome, in particular the order of appearance of different types of complications (arterial, digestive, pulmonary and uterine).

time_perspective: Other

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

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Brabois
Hôpital Rangueil
Hôpital Hôtel Dieu
Hôpital Gabriel Montpied
Hôpital Côte de Nacre
Centre Hospitalier Universitaire Angers
Hôpital de la Timone
Hôpital Femme Mère Enfant
Hôpital Saint-Eloi
Hôpital Edouard Herriot
Hôpital de la Cavale Blanche
Hôpital Nord
Hôpital Trousseau
Hôpital Michallon
Hôpital Saint-André
Hôpital Claude Huriez


title: National Cohort About Epidemiology, Clinical and Genetic Heterogeneity of the "Low-Phospholipid-Associated Cholelithiasis" (LPAC) Syndrome

acronym: COLPAC

summary:
The goal of this observational study is to describe the various clinical, biological and radiological manifestations of LPAC syndrome, defined according to standard diagnostic criteria, or according to criteria extended to all symptomatic recurrent biliary lithiasis, and delineate the various possible evolutions.

Participants will be followed for 5 years and the inclusion sites will collect the necessary data at least once a year as part of routine patient care. A quality of life self-questionnaire will be completed by participants during these visits.

location_facility: Centre Hospitalier Intercommunal Aix-Pertuis

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Primary Ciliary Dyskinesias: Identification of Specific Severity Criteria and Phenotype-genotype Correlation Study

acronym: DCP

summary:
Primary Ciliary Dyskinesias (PCD) are rare, autosomal recessive respiratory diseases, due to a defect in mucociliary clearance linked to abnormalities in the structure and/or function of the cilia. The variety of ciliary abnormalities identified reflects the genetic heterogeneity of PCDs. The thirty or so genes currently implicated explain the pathology in about half of the patients. PCDs are characterized by recurrent infections of the upper (rhinosinusitis) and lower (bronchitis) airways, beginning in early childhood and progressing respectively to nasal polyposis and bronchial dilatation. In half of the cases, there is a lateralization defect of the organs (situs inversus) corresponding to Kartagener's syndrome. There is more frequent infertility in men (immobility of spermatozoa) than in women (miscarriages and tubal pregnancies). About a third of patients progress to respiratory failure. The identification of predictive factors of severity, specific to PCDs, would improve patient care. It is also important to assess the quality of life of patients with PCD, particularly at the ENT level.

Data from prevalent patients are currently integrated into three separate and complementary databases: the "e-RespiRare" database, the "DCP Cils" database and the "DCP genes" database. The first step is therefore to constitute the RaDiCo-DCP database which will include data from prevalent and incident patients whose diagnosis of PCD is certain.

The cohort aims to improve the routine care of PCD patients, in particular by highlighting predictive factors of severity, allowing early and personalized care, to assess the social impact (quality of life) and medical conditions of ENT impairment, as well as adult infertility, to finely characterize the ciliary phenotype. The study also aims to search for new DCP genes and to allow genotype/phenotype correlation studies.


title: National Cohort on Imprinting Disorders and Their Metabolic Consequences

acronym: IDMet

summary:
The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of the disease, with a molecular characterization, with a signed informed consent for all subjects, followed in one partner's center.

The main questions it aims to answer are:

Can we identify common metabolic profiles for all imprinted diseases?
Which imprinting disorders have an impact on the metabolic profiles of IDs?
Which are the metabolic risks associated to IDs?
Can we use the metabolic profiles for the clinical classification and prognosis of IDs?
Are there common therapeutic approaches for all IDs?

location_facility:
Hôpital des Enfants
Hôpital de la mère et de l'enfant
Hôpital Brabois
Hôpital Jean Minjoz
Hôpital Gabriel Montpied
Hôpital Civil
Hôpital Armand-Trousseau
Hôpital Jeanne de Flandre
Hôpital enfant-adolescent
Hôpital Necker Enfants Malades
Hôpital Femme Mère Enfant
CHU d'Angers
Hôpital Robert Debré
Hôpital Bicêtre
Hôpital de la Timone
Hôpital Bretonneau
Hôpital de la Pitié-Salpêtrière
Hôpital Sud


title: Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

acronym: MULTISARC

summary:
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays.

In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq [NGS]) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant's tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial.

primary_purpose: Health Services Research

ReferenceCitation: Italiano A, Dinart D, Soubeyran I, Bellera C, Esperou H, Delmas C, Mercier N, Albert S, Poignie L, Boland A, Bourdon A, Geneste D, Cavaille Q, Laizet Y, Khalifa E, Auzanneau C, Squiban B, Truffaux N, Olaso R, Gerber Z, Wallet C, Benard A, Blay JY, Laurent-Puig P, Deleuze JF, Lucchesi C, Mathoulin-Pelissier S; MULTISARC study group. Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial. BMC Cancer. 2021 Nov 5;21(1):1180. doi: 10.1186/s12885-021-08878-2.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

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

collaborators: Plateforme labellisée Inca - Institut Bergonié, Bordeaux

collaborators: Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

location_facility: ICANS - Institut de Cancérologie Strasbourg


title: National Cohort for Evaluation of the Burden of Rare Skin Diseases

acronym: FARD

summary:
The goal of this observational study is to conduct a prospective assessment of the individual Burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families.

Two types of indicators will be used to reach this objective :

an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. The burden questionnaire should be used by patients and/or their family themselves in self-assessment.
a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.

location_facility: Hôpital des Enfants - Groupe Hospitalier Pellegrin


title: Clinical, Molecular and Metabolic Comparison Between Early Onset Parkinsonian, With or Without Parkin Mutation: Physiopathological Perspectives

summary:
Parkinson's disease is one of the most frequent neurodegenerative diseases, and for which the mechanisms remains unknown. Since the implication of susceptibility factors is highly suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene was responsible for an important proportion of early onset familial and isolated cases. Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson's disease and secondary Parkinson's disease with a Parkin gene mutation at the clinical, neuropsychological, metabolic and physiopathological levels. For establishing phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a Parkin mutation (parkin " + ", n=25) to those of early onset parkinsonians without a Parkin mutation (Parkin " - ", n = 25), and for some aspects (neuropsychological, behavioural and psychiatric evaluations) to the healthy brothers and sisters of Parkin cases "+"(n = 25). The evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations), molecular (types of abnormalities in the Parkin gene) and metabolic (PET - tomography by positron emission) of the disease.

Parkinson's disease caused by Parkin gene mutations is associated with an important and homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is different from those observed during the idiopathic Parkinson's disease. The corresponding dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the massive alteration of dopaminergic efferences.

This multidisciplinary approach on Parkin cases will be performed in the centers for of clinical investigations of Grenoble and Paris, with the help of the French Parkinson's Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a better definition of diagnostic criteria of Parkin " + " cases, which will help for the molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems to be different of idiopathic Parkinson's disease.

location_facility: Pitié-Salpêtrière Hospital - Service of Psychiatry

location_facility: Pitié-Salpêtrière Hospital - Centre of Clinical Investigations

location_facility: Pitié-Salpêtrière Hospital - Federation of Neurology


title: Natural History, Genetic Bases and Phenotype-genotype Correlations in Autosomal Dominant Spinocerebellar Degenerations

summary:
The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically and genetically, group of rare diseases and of severe evolution. So far, the responsible genes for less than 50% of the cases are known and because of their rarity, there are no phenotype-genotype correlations and well-defined disease history.

The aims of the project are to develop and validate quantitative tools of the cerebellar syndrome and of the spasticity, to establish links between the phenotype and the result of the molecular analysis, to identify new loci/genes responsible for these disorders, and to establish the natural history of the disease according to the genotype.

To this end, a prospective and multicentric study is proposed for recruiting and evaluating, clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers involved. A DNA collection will be set up in order to search for the implication of new loci and genes. A clinico-genetic database will be set up combining data from successive clinical evaluations and those of genotyping.

This strategy will allow access to genetic counselling and molecular diagnosis (positive, presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype correlations and the information concerning the relative frequency of the genes. The detailed description, with the help of new evaluation tools and of the follow-up of the natural history of the disease according to the genotype, constitutes a crucial step in the design of therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by specialized centers will allow better care of the patients.

ReferenceCitation: Klebe S, Durr A, Rentschler A, Hahn-Barma V, Abele M, Bouslam N, Schols L, Jedynak P, Forlani S, Denis E, Dussert C, Agid Y, Bauer P, Globas C, Wullner U, Brice A, Riess O, Stevanin G. New mutations in protein kinase Cgamma associated with spinocerebellar ataxia type 14. Ann Neurol. 2005 Nov;58(5):720-9. doi: 10.1002/ana.20628.

ReferenceCitation: Stevanin G, Hahn V, Lohmann E, Bouslam N, Gouttard M, Soumphonphakdy C, Welter ML, Ollagnon-Roman E, Lemainque A, Ruberg M, Brice A, Durr A. Mutation in the catalytic domain of protein kinase C gamma and extension of the phenotype associated with spinocerebellar ataxia type 14. Arch Neurol. 2004 Aug;61(8):1242-8. doi: 10.1001/archneur.61.8.1242.

ReferenceCitation: Stevanin G, Durr A, Dussert C, Penet C, Brice A. Mutations in the FGF14 gene are not a major cause of spinocerebellar ataxia in Caucasians. Neurology. 2004 Sep 14;63(5):936. doi: 10.1212/01.wnl.0000137020.30604.1e. No abstract available.

ReferenceCitation: Waters MF, Minassian NA, Stevanin G, Figueroa KP, Bannister JP, Nolte D, Mock AF, Evidente VG, Fee DB, Muller U, Durr A, Brice A, Papazian DM, Pulst SM. Mutations in voltage-gated potassium channel KCNC3 cause degenerative and developmental central nervous system phenotypes. Nat Genet. 2006 Apr;38(4):447-51. doi: 10.1038/ng1758. Epub 2006 Feb 26.

ReferenceCitation: Depienne C, Tallaksen C, Lephay JY, Bricka B, Poea-Guyon S, Fontaine B, Labauge P, Brice A, Durr A. Spastin mutations are frequent in sporadic spastic paraparesis and their spectrum is different from that observed in familial cases. J Med Genet. 2006 Mar;43(3):259-65. doi: 10.1136/jmg.2005.035311. Epub 2005 Jul 31.

ReferenceCitation: Depienne C, Fedirko E, Forlani S, Cazeneuve C, Ribai P, Feki I, Tallaksen C, Nguyen K, Stankoff B, Ruberg M, Stevanin G, Durr A, Brice A. Exon deletions of SPG4 are a frequent cause of hereditary spastic paraplegia. J Med Genet. 2007 Apr;44(4):281-4. doi: 10.1136/jmg.2006.046425. Epub 2006 Nov 10.

ReferenceCitation: Depienne C, Fedirko E, Faucheux JM, Forlani S, Bricka B, Goizet C, Lesourd S, Stevanin G, Ruberg M, Durr A, Brice A. A de novo SPAST mutation leading to somatic mosaicism is associated with a later age at onset in HSP. Neurogenetics. 2007 Aug;8(3):231-3. doi: 10.1007/s10048-007-0090-4. Epub 2007 Jun 28.

ReferenceCitation: Hanein S, Durr A, Ribai P, Forlani S, Leutenegger AL, Nelson I, Babron MC, Elleuch N, Depienne C, Charon C, Brice A, Stevanin G. A novel locus for autosomal dominant "uncomplicated" hereditary spastic paraplegia maps to chromosome 8p21.1-q13.3. Hum Genet. 2007 Nov;122(3-4):261-73. doi: 10.1007/s00439-007-0396-1. Epub 2007 Jun 28.

ReferenceCitation: Ribai P, Depienne C, Fedirko E, Jothy AC, Viveweger C, Hahn-Barma V, Brice A, Durr A. Mental deficiency in three families with SPG4 spastic paraplegia. Eur J Hum Genet. 2008 Jan;16(1):97-104. doi: 10.1038/sj.ejhg.5201922. Epub 2007 Oct 24.

ReferenceCitation: du Montcel ST, Charles P, Ribai P, Goizet C, Le Bayon A, Labauge P, Guyant-Marechal L, Forlani S, Jauffret C, Vandenberghe N, N'guyen K, Le Ber I, Devos D, Vincitorio CM, Manto MU, Tison F, Hannequin D, Ruberg M, Brice A, Durr A. Composite cerebellar functional severity score: validation of a quantitative score of cerebellar impairment. Brain. 2008 May;131(Pt 5):1352-61. doi: 10.1093/brain/awn059. Epub 2008 Mar 31.

ReferenceCitation: Goizet C, Boukhris A, Mundwiller E, Tallaksen C, Forlani S, Toutain A, Carriere N, Paquis V, Depienne C, Durr A, Stevanin G, Brice A. Complicated forms of autosomal dominant hereditary spastic paraplegia are frequent in SPG10. Hum Mutat. 2009 Feb;30(2):E376-85. doi: 10.1002/humu.20920.

ReferenceCitation: Tezenas du Montcel S, Durr A, Rakowicz M, Nanetti L, Charles P, Sulek A, Mariotti C, Rola R, Schols L, Bauer P, Dufaure-Gare I, Jacobi H, Forlani S, Schmitz-Hubsch T, Filla A, Timmann D, van de Warrenburg BP, Marelli C, Kang JS, Giunti P, Cook A, Baliko L, Melegh B, Boesch S, Szymanski S, Berciano J, Infante J, Buerk K, Masciullo M, Di Fabio R, Depondt C, Ratka S, Stevanin G, Klockgether T, Brice A, Golmard JL. Prediction of the age at onset in spinocerebellar ataxia type 1, 2, 3 and 6. J Med Genet. 2014 Jul;51(7):479-86. doi: 10.1136/jmedgenet-2013-102200. Epub 2014 Apr 29. Erratum In: J Med Genet. 2014 Sep;51(9):613. Bela, Melegh [corrected to Melegh, Bela].

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

url: http://publikationen.ub.uni-frankfurt.de/files/34402/j med genet-2014-tezenas du montcel-479-86.pdf

url_for_pdf: http://publikationen.ub.uni-frankfurt.de/files/34402/J Med Genet-2014-Tezenas du Montcel-479-86.pdf

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

publisher_dissemination: British Medical Journal

ReferenceCitation: Tezenas du Montcel S, Charles P, Goizet C, Marelli C, Ribai P, Vincitorio C, Anheim M, Guyant-Marechal L, Le Bayon A, Vandenberghe N, Tchikviladze M, Devos D, Le Ber I, N'Guyen K, Cazeneuve C, Tallaksen C, Brice A, Durr A. Factors influencing disease progression in autosomal dominant cerebellar ataxia and spastic paraplegia. Arch Neurol. 2012 Apr;69(4):500-8. doi: 10.1001/archneurol.2011.2713.

location_facility:
Hôpital Purpan
Hôpital Pellegrin
Hôpital Pitié-Salpêtrière
Hôpital Carémeau
CHU de Grenoble
Hôpital La Timone
Hôpital Charles Nicolle
Hôpital Neurologique Pierre Wertheimer


title: CARdiomyopathy in Type 2 DIAbetes Mellitus

acronym: CARDIATEAM

summary: The objective of the CARDIATEAM clinical study is to assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy using unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information.

location_country:
Germany
United Kingdom
Netherlands
Spain
France

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: University of Dundee, Div of Molecular&Clinical Medicine

location_facility: University Medical Center Groningen (UMCG), Cardiology/Cardio Research

location_facility: Diabetology departement, Lariboisière Hospital

location_facility: Cardiology Outpatient Department at Hôpital Henri Mondor.

location_facility: Institut D'Investigacions Biomedica August Pi I Sunyer (IDIBAPS)

location_facility: Academisch ziekenhuis Maastricht, Cardiology

location_facility: department of diabetology and nutrition, APHM

location_facility: Diabetology department, Cochin Institute


type: Registry Identifier

title: Use of Home-based Connected Devices to Early Detect and Treat Pulmonary Exacerbations: Feasibility and Clinical Validity in CF Patients

acronym: MucoExocet

summary:
Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home-based connected devices (CDs) in educated patients applying Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients' perception reported (PRP), will allow early detection of PEx.

Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in CF patients and teams

Design: 3 phase multicenter study in 36 CF patients aged >=12 years. Phase 1, patients are equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP and PRP are collected during 12 months. Clinical validity, change in patients clinical data, quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence are assessed.

ReferenceCitation: Morsa M, Perrin A, David V, Rault G, Le Roux E, Alberti C, Gagnayre R, Pougheon Bertrand D. Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study. JMIR Res Protoc. 2021 Aug 18;10(8):e14552. doi: 10.2196/14552.

publisher_dissemination: JMIR Publications

collaborators:
Fondation pour la Recherche Médicale
Vertex Pharmaceuticals Incorporated
Fondation Ildys

location_facility: CF adults and pediatrics center - American Memorial Hospital

location_facility: CF pediatrics center - Hopital Mère-Enfant

location_facility: CF pediatrics center - Hopital Robert Debré

location_facility: CF adults center - Hopital Albert Calmette

location_facility: CF pediatrics center - Hopital André Mignot

location_facility: CF adults and pediatrics center- Perharidy


title: Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction

acronym: FA-O'DIDE

summary: Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this within SUD management, it is important to establish a confident relation between the patient and the care team to favorize acre observance. However, it demands an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. With the present study, the investigator postulated that an application called Ô DIDE for Digital Interaction for Detoxification Engagement, that aims to help the caregivers maintaining a link with the patient in order to facilitate confidence in the relationship, could favorize care observance especially consumption report.

lead_sponsor: University Hospital, Toulouse

collaborators: Institut de Recherche en Santé Publique, France


title: Electroclinical Correlation of Anxiety, Evidences From Intracerebral Recordings

acronym: IRAnxNet

summary: Anxiety disorders have the highest prevalence among mental disorders and cause considerable individual and financial costs. Current treatments do not relieve mental suffering of many patients. Understanding neurobiological mechanisms involved in pathological anxiety is a major scientific challenge.

collaborators: Centre National de la Recherche Scientifique, France

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


title: Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma

acronym: IPRICE

summary: This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.

lead_sponsor: Institut de cancérologie Strasbourg Europe

sponsor_collaborators: Centre National de la Recherche Scientifique, France


title: Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

summary:
It's clearly known that lymphocyte activation in particular Th17 response, plays a major role in the development of plaque psoriasis. New therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis.

Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes and they're functional role is supported by the inhibition of IL-17 production by a pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling responsible for the production of Th17 cytokines represents an interesting therapeutic target in Psoriasis.

The aim of the study is to explore biological functions related to the activation of the Cav1.4 pathway in Psoriasis.

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Service de Dermatologie - Hôpital Larrey