title: Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water

summary: Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.

lead_sponsor: Cosmetique Active International


title: Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial

acronym: SKIPA

summary: Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Hersant J, Ramondou P, Josse C, Lecoq S, Henni S, Abraham P. Quantitative analysis of venous outflow with photo-plethysmography in patients with suspected thoracic outlet syndrome. Front Cardiovasc Med. 2022 Oct 28;9:803919. doi: 10.3389/fcvm.2022.803919. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Oximetrie Transcutanee et Ischemie Critique

acronym: CITRA

summary: Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

status: Unknown status

ipd_sharing: Undecided

ipd_sharing_description: Data available under reasonable request to the investigator

status_simplified: Unknown


title: Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte

acronym: BREIZH-Cohorte

summary: The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Interventional

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

intervention_type: Biological


title: Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure

acronym: FIT-H

summary:
Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE during hormonal exposure, thrombophilia testing is often performed in order to adapt contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such practice is probably not accurate nor discriminent. Indeed, there are evidence that the impact of the familial history of VTE might be stronger than that of detectable inherited thrombophilia.

The "FIT-H" study is a cross-sectional study comparing the prevalence of previous venous thromboembolism in first-degree relatives of women (propositi) who had a first episode of venous thromboembolism in association with hormonal exposure with the prevalence of previous venous thromboembolism in first-degree relatives of women who did not have venous thromboembolism during a similar hormonal exposure.

The primary objective is to determine the association between the presence or the absence of VTE in young women during hormonal exposure and the presence or the absence of a previous episode of VTE in their first-degree relatives. Secondary objective is to determine the impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.

intervention_type: Other


acronym: Xeladys

intervention_type: Drug

lead_sponsor: Centre Hospitalier Universitaire, Amiens

summary:
Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least three months. This important public health issue arises for 15-20% of patients treated with neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and seriously impacts the patients' quality of life. In over 50% of cases, it is irreversible-that is to say that he will persist despite discontinuation of the offending drug.

Risk factors have been described: the age and female gender are established, a higher dosage of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or powerful, longer term use of corrective treatments including anticholinergics are still discussed.

Apart from preventive treatment, which consists in using antipsychotics as being coerced, support is disappointing: the etiological treatment, which is to stop the offending antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late irreversible. Must still have the possibility to interrupt the treatment, which is usually impossible in the risk of decompensation of the mental illness for which the neuroleptic was prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases, because it is not without risk, in terms of morbidity and mortality. So it's the medication that is most often offered: many drugs have been proposed, a direct result of the multiplicity of neurotransmitter systems implicated.

However, in the vast majority of cases, this approach is disappointing not to say ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®. Empirically, neurologists specializing in pathology of the movement are almost unanimous: its efficiency is very good, with good tolerance. Some preliminary studies have reinforced this impression. However, their level of evidence remains low and that is why the investigators propose to implement a prospective multicenter clinical trial, double-blind with placebo which will include two groups of 27 patients.

location_facility:
CHU Toulouse
CHU Nice
CHU Limoges
CHU de Rennes
CHU Amiens
CH des Charpennes
CHU Rouen
CHU Nantes
CHU Montpellier
CH Aix en Provence
CHU Clermont-Ferrand
CHRU Lille
CHU Caen
CHU Strasbourg
AP-HM Hopital de la Timone
CHU Saint Antoine
CHU Poitiers
CHU Bordeaux
CHRU de Nimes

status: Completed

title: Study of Efficacy and Acceptability of Tetrabenazine in the Late Dyskinetic Syndrome With Neuroleptics: A Randomized, Parallel Group, Double-blind Placebo Controlled Multicentre Trial

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

status_simplified: Completed


title: Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.

acronym: TETRAMINF

summary:
Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.

The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.

ReferenceType: background

ReferenceCitation: Mateo S, Di Rienzo F, Reilly KT, Revol P, Delpuech C, Daligault S, Guillot A, Jacquin-Courtois S, Luaute J, Rossetti Y, Collet C, Rode G. Improvement of grasping after motor imagery in C6-C7 tetraplegia: A kinematic and MEG pilot study. Restor Neurol Neurosci. 2015;33(4):543-55. doi: 10.3233/RNN-140466.

ipd_sharing_description:
Individual participant data will be shared after deidentification (but only the data required for the new analysis will be transmitted). This includes for each visit and each participant averaged data of wrist extension angle during grasping of a single upper limb measured in degree with 3D motion analysis system.

This includes for each visit, each participant and each upper limb:

Box and Block test
Nine Hole Peg test
hand held dynamometer for each of 4 muscles

This includes for each visit and each participant the total score of:

manual muscle testing of the upper limb key muscles as defined by the ASIA score for each arm
Capability of Upper Limb
WHOQOL-Bref
Quadriplegic Index of Function
Kinesthetic Visual Imagery Questionnaire This also includes for each visit and each participant the passive range of motion expressed in degree and measured using goniometer for shoulder, elbow and wrist.

This do not include electrophysiological measurements.

lead_sponsor: Hospices Civils de Lyon

location_facility: Le Centre Mutualiste Neurologique PROPARA, Parc Euromédecine

location_facility: Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle

intervention_type: Behavioral

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: TetraNBF

titre: Rééducation de la préhension par neurobiofeedback couplé à l'imagerie motrice chez les patients tétraplégiques C6-C7. Etude randomisée contrôlée.

discipline_principale: médecine physique et réadaptation

nom_porteur: MATEO

prenom_porteur: Sébastien


title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)

acronym: TOP-UP

summary:
The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:

Specific Aims

Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.

Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.

To ensure adequate glycemic control in both groups.
To ensure that the other metabolic consequences of the feeding strategies are minimized.
To establish adequate compliance with study protocols and completion of case report forms

A secondary aim of this pilot study will be:

• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.

status: Terminated

primary_purpose: Prevention

ReferenceCitation: Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2. Erratum In: Intensive Care Med. 2009 Oct;35(10):1821.

ReferenceCitation: Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.

ReferenceCitation: Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305. doi: 10.1378/chest.124.1.297.

ReferenceCitation: Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65. doi: 10.1016/j.jada.2006.12.012.

ReferenceCitation: Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. doi: 10.1007/s00134-004-2345-y. Epub 2004 Jun 8.

ReferenceCitation: Wischmeyer PE, Hasselmann M, Kummerlen C, Kozar R, Kutsogiannis DJ, Karvellas CJ, Besecker B, Evans DK, Preiser JC, Gramlich L, Jeejeebhoy K, Dhaliwal R, Jiang X, Day AG, Heyland DK. A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care. 2017 Jun 9;21(1):142. doi: 10.1186/s13054-017-1736-8.

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

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Duke University - DukeSpace

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
dukespace.lib.duke.edu
localhost

repositories_institution:
Duke University - DukeSpace
PubMed Central - Europe PMC
University of Toronto - TSpace

publisher_dissemination: Springer-Nature

lead_sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

location_country:
United States
Canada
Belgium
France

location_facility: University of Texas Health Science Center

location_facility: The Ohio State Univsersity Medical Center

location_facility: Washington University School of Medicine in St. Louis

location_facility: Cleveland Clinic Lerner College of Medicine


title: Evaluating the Validity and Acceptability of a Fully-automated Interview to Diagnose Insomnia Disorder: a Pilot Study

summary:
Objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients.

Study main outcomes:

Concurrent validity (sensitivity and specificity) compared to a gold standard. Gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder
Acceptability of the fully-automated interview.

Participants:

Volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at Bordeaux University Hospital between May 2023 and July 2023.

ReferenceCitation: Philip P, Dupuy L, Morin CM, de Sevin E, Bioulac S, Taillard J, Serre F, Auriacombe M, Micoulaud-Franchi JA. Smartphone-Based Virtual Agents to Help Individuals With Sleep Concerns During COVID-19 Confinement: Feasibility Study. J Med Internet Res. 2020 Dec 18;22(12):e24268. doi: 10.2196/24268.

ReferenceCitation: Auriacombe M, Fournet L, Dupuy L, Micoulaud-Franchi JA, de Sevin E, Moriceau S, Baillet E, Alexandre JM, Serre F, Philip P. Effectiveness and Acceptance of a Smartphone-Based Virtual Agent Screening for Alcohol and Tobacco Problems and Associated Risk Factors During COVID-19 Pandemic in the General Population. Front Psychiatry. 2021 Jul 16;12:693687. doi: 10.3389/fpsyt.2021.693687. eCollection 2021.

ReferenceCitation: Dupuy L, Morin CM, de Sevin E, Taillard J, Salles N, Bioulac S, Auriacombe M, Micoulaud-Franchi JA, Philip P. Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population. J Sleep Res. 2022 Apr;31(2):e13489. doi: 10.1111/jsr.13489. Epub 2021 Sep 18.

ReferenceCitation: Philip P, Dupuy L, Sagaspe P, de Sevin E, Auriacombe M, Taillard J, Micoulaud-Franchi JA, Morin CM. Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. J Clin Med. 2022 Jul 28;11(15):4387. doi: 10.3390/jcm11154387.

lead_sponsor: University of Bordeaux


acronym: BenraliScan

lead_sponsor: University Hospital, Montpellier

summary:
BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future level of patient response to a monoclonal antibody. Because the clinical responses under study can take many months to manifest, early identification of patients most-likely to benefit from treatment and treatment rule-out for others will save considerable time for everybody involved.

The primary objective of BenraliScan is to determine the prognostic value (sensitivity, specificity, positive predictive value, negative predictive value) of air-trapping measures (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with Benralizumab.

sponsor_collaborators:
University Hospital, Montpellier
AstraZeneca

location_facility: Assistance Publique - Hopitaux de Marseille

title: Computed Tomography Air-trapping Characterisation for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients

primary_purpose: Diagnostic

ipd_sharing: No


type: Registry Identifier

title: Assessment of Sense of Identity in Patients With a Diagnosis of Borderline Personality Disorder Through Autobiographical Memory and the Contents of Self-defining Memories, Compared to a Group of Healthy Individuals. A Pilot Study

acronym: MASB

summary:
One of the key features and long considered a fundamental element of Borderline Personality Disorder is the disruption of identity. Autobiographical memory is closely linked to the development and maintenance of a coherent, stable sense of self. It enables the individual to understand who he or she is. The investigators hypothesize that individuals diagnosed with Borderline Personality Disorder have a less coherent, stable sense of the self than healthy controls. The aim of the study is therefore to compare the sense of identity between a group of patients diagnosed with Borderline Personality Disorder and a group of healthy individuals (without Borderline Personality Disorder ).

This can be measured by evaluating the content of the self-defining memory using the Self-Defining Memory scale.

time_perspective: Retrospective

ReferenceCitation: Moffitt KH, Singer JA. Continuity in the Life Story: Self-Defining Memories, Affect, and Approach/Avoidance Personal Strivings. Journal of Personality.1994; 62(1), 21-43

ReferenceCitation: Singer, J. A., & Moffitt, K. H. An experimental investigation of specificity and generality in memory narratives. Imagination, Cognition and Personality. PsycINFO Database Record (1991-1992)11(3), 233-257.

ReferenceCitation: Bluck S, Alea N. Crafting the TALE: construction of a measure to assess the functions of autobiographical remembering. Memory. 2011 Jul;19(5):470-86. doi: 10.1080/09658211.2011.590500.

ReferenceCitation: Johnson MK, Foley MA, Suengas AG, Raye CL. Phenomenal characteristics of memories for perceived and imagined autobiographical events. J Exp Psychol Gen. 1988 Dec;117(4):371-6.

ReferenceCitation: Bernstein, D. P., Fink, L., Handelsman, L., & Foote, J. Childhood Trauma Questionnaire (CTQ) [Database record].(1994) APA PsycTests. https://doi.org/10.1037/t02080-000

ReferenceCitation: Spitzer, Robert L, Williams Janet BW, Gibbon Miriam, First Michael B, Structured Clinical Interview for DSM-III-R Axis II Disorders,(SCID-II), Washington, D.C.: American Psychiatric Press, Inc., 1990

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Functional and Cognitive Assessment of Patients With Hodgkin's Disease Undergoing Chemotherapy Before 40 Years

acronym: FunC-AHOD

summary:
A few studies have focused on other solid cancers (colorectal, prostate). On the other hand, the study of cognitive impairment in Hodgkin's disease remains less developed, and structural and functional post-therapy MRI studies have never been carried out. The impact of cognitive impairment on Hodgkin's disease is rarely, if ever, assessed in routine clinical practice, despite the fact that it is truly disabling in 16 to 30% of patients. Cognitive impairment can persist long after diagnosis and treatment. A recent study examining cognitive functioning in patients an average of 13 years after treatment found that disorders persisted in 52% of cases, with attentional, working memory and dysexecutive (planning) difficulties. These disorders have a significant impact on the daily and professional lives of these young, often working patients. Their rapid development and persistence after treatment can therefore represent a real limiting factor, impacting both professional integration and quality of life. Finally, the current state of knowledge does not allow us to dissociate cognitive disorders from emotional disorders and fatigue, which represent a major patient complaint. A better definition of the nature, pathophysiology and specificity of these disorders would therefore enable us to take better account of their repercussions (social, professional and on quality of life) and provide better care (in terms of cognitive remediation or psychological support).

A prospective, longitudinal, multicenter, case-control interventional study in which cases are patients with Hodgkin's disease (HD) treated with CT +/- radiotherapy and controls are healthy participants will be conducted. The aim is to study the prevalence and nature of treatment-induced cognitive impairment and its correlation with emotional comorbidities, as well as structural and functional brain disorders on MRI. The patient will thus be his or her own witness, the reference state being that at the time of diagnosis, before any treatment. The fact that this state has not already been altered by the disease itself, will be verify thanks to comparison with controls.

design_allocation: Non-Randomized

lead_sponsor: Lille Catholic University

location_facility:
Centre Hospitalier Artois Ternois
Hôpital Victor Provo
Hôpital Claude Huriez
Hôpital Saint-Philibert


acronym: PAKT

lead_sponsor: Queen Mary University of London

summary:
PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy).

Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity.

Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.

ReferenceType: result

ReferenceCitation: Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial. J Clin Oncol. 2020 Feb 10;38(5):423-433. doi: 10.1200/JCO.19.00368. Epub 2019 Dec 16.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Cambridge - Apollo

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

sponsor_collaborators:
Queen Mary University of London
AstraZeneca
Cancer Research UK

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Yeovil District Hospital NHS Foundation Trust

location_facility: University Hospital of North Staffordshire NHS Trust

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Southampton University Hospitals NHS Trust

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Guys and St Thomas' NHS Foundation Trust

location_facility: Glan Clwyd Hospital BCU Health Board NHS Wales

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Prof. Dr. I. Chiricuta Oncology Institute

location_facility: Royal Marsden NHS Foundation Trust-Fulham

location_facility: University Hospitals Coventry and Warwickshire NHs Trust

location_facility: Sf. Nectarie SRL Oncologie Medical Center

location_facility: University of Pécs - Clinical Center Institute of Oncotherapy

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Abertawe Bro Margannwg University Health Board

title: A Phase II, Double-blind, Randomised, Placebo-controlled Study of the AKT Inhibitor AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer (PAKT).

location_country:
Hungary
United Kingdom
Romania
Korea, Republic of
Georgia
France

collaborators:
AstraZeneca
Cancer Research UK


title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm

acronym: LEVEA

summary: The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.

lead_sponsor: LivaNova

intervention_type: Device

lead_sponsor_type: industriel


title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer

summary: The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

lead_sponsor: AstraZeneca

location_facility:
Research SIte
Research Site


title: Comparison of Efficacy of Two Mandibular Advancement Devices (MADs) and Insights Gain From Analysis of Mandibular Behavior During Sleep

acronym: SONAR

summary: Mandibular Advancement Devices (MADs) are now a reliable alternative to continuous positive airway pressure (CPAP) treatments for Obstructive Sleep Apnea (OSA) . Despite good tolerance and efficacy, there are still barriers limiting the widespread use of MAD and its acceptance in OSA routine clinical practice. Various MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise. Although these MAD has been tested in term of efficacy, no study has tested the difference between MADs in term of efficacy, tolerance and patient satisfaction. The aim of this clinical trial is to compare the effectiveness of two MADs - custom-made titratable MAD (NarvalTM) and customizable titratable MAD (TALITM), over a 3-month period, in patients with obstructive sleep apnea (OSA).

lead_sponsor: University Hospital, Grenoble


title: Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

acronym: CLOWN-TOX

summary: In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers

time_perspective: Prospective

ReferenceCitation: Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.

ReferenceCitation: Hansen LK, Kibaek M, Martinussen T, Kragh L, Hejl M. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study. J Pain Res. 2011;4:297-300. doi: 10.2147/JPR.S23199. Epub 2011 Sep 21.

ReferenceCitation: Molenaers G, Schorkhuber V, Fagard K, Van Campenhout A, De Cat J, Pauwels P, Ortibus E, De Cock P, Desloovere K. Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency. Eur J Paediatr Neurol. 2009 Sep;13(5):421-9. doi: 10.1016/j.ejpn.2008.07.008. Epub 2008 Nov 1.

ReferenceCitation: Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.

ReferenceCitation: Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Remy-Neris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys Rehabil Med. 2009 Dec;52(10):704-16. doi: 10.1016/j.rehab.2009.09.001. Epub 2009 Oct 6.

ReferenceCitation: Bayon-Mottu M, Gambart G, Deries X, Tessiot C, Richard I, Dinomais M. Pain during injections of botulinum toxin in children: Influence of the localization technique. Ann Phys Rehabil Med. 2014 Dec;57(9-10):578-86. doi: 10.1016/j.rehab.2014.09.010. Epub 2014 Oct 8.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Houx L, Dubois A, Brochard S, Pons C. Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children? Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.


title: Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

acronym: AMBU-ENDO

summary:
To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Ecole d'econmie de Paris (PSE)-Hospinnomics

collaborators: Université de Rennes 1 CREM CNRS UMR 6211

location_facility: Hôpital Bichat-Claude Bernard Gynécologie obstétrique

location_facility: Service de chirurgie gynécologique, hôpital Tenon

location_facility: Service de chirurgie gynécologique, Centre Hospitalier Simone Veil

location_facility: HEGP - Chirurgie Cancérologique Gynécologique et du Sein

location_facility: Service de Chirurgie Gynécologique Obstétrique Reproduction Humaine

location_facility: Service de chirurgie gynécologique, hôpital Pitié-salpêtrière

location_facility: Service de chirurgie gynécologique, Centre de lutte contre le cancer

intervention_type: Procedure

appel_a_projets: PRMEK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: AMBU-ENDO

titre: Cost-utility, safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer: a multicentre, prospective and randomised study.

discipline_principale: gynecological cancer: endometrial cancer

nom_porteur: CANLORBE

prenom_porteur: Geoffroy


type: Other Identifier

title: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response

summary:
Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.

With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.

The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.

The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.

Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.

The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.

lead_sponsor: Weprom

collaborators:
SIVAN Innovation
Takeda

sponsor_collaborators:
Weprom
SIVAN Innovation
Takeda

location_facility: Centre Hospitalier Universitaire Jean Minjoz

location_facility: Institut d'Hématologie de Basse Normandie


title: Evaluation of the Effectiveness of the Application of a Protocol for the Management of Female Functional Urinary Signs in French Community Pharmacies

acronym: PharmaCyst'

summary:
Every year, between 4 and 6 million French people are affected by a urinary infection; the vast majority of these are women. Although the diagnosis of an uncomplicated urinary tract infection is simple to make, it requires prompt medical management to relieve the symptoms. The lack of immediate of a physician can slow down the management of patients affected by this condition, and lead to an inappropriate referral of patients to the emergency services.

Because of their wide availability, accessibility, and geographical distribution throughout the country, pharmacists are primary health care professionals who are regularly called upon to respond to patients with this type of infection.

A national protocol exists in France, but it is very difficult to apply. The PharmaCyst' study aims to evaluate its application in community pharmacies.

collaborators: Agence régionale de santé, région Pays de la Loire

collaborators: Union régionale des professionnels de santé Pharmacien, région Pays de la Loire

location_facility:
Pharmacie de la Place
Pharmacie de Brûlon
Pharmacie de la Presqu'île
Pharmacie du Chemin Vert
Pharmacie Flotté
Pharmacie du Louet
Pharmacie de la Source
Pharmacie du Clocher
Pharmacie Nicolleau-Dilé
Pharmacie Degueille
Pharmacie du Pays De Retz
Pharmacie du Centre
Pharmacie des Rives du Loir
Pharmacie des Halles
Pharmacie Principale Harel
Pharmacie Leeuws-Guilloton
Pharmacie de Gazonfier
Pharmacie des Arcades
Pharmacie Llacuna
Pharmacie de la Pointe
Pharmacie Deroche
Pharmacie des Glycines

appel_a_projets: RESPIR

region: Pays de la Loire

nom_etablissement: GCS HUGO - ET SIEGE

type_etablissement: GCS

acronyme: PharmaCyst

titre: Évaluation de l'efficacité de l'application d'un protocole de prise en charge des signes fonctionnels urinaires de la femme en pharmacie d'officine

discipline_principale: note, co-porteur soin primaire, piraux arthur

nom_porteur: FAURE


title: Prospective, Non-randomized, Single Center Clinical Study of Cervical Interbody Fusion Using a Viral-inactivated Allogeneic Graft

summary: This is a prospective, single arm, single center clinical study to evaluate efficacy and safety of a Supercritical CO2 viral-inactivated allogenic bone paste in cervical interbody fusion. Patient eligible for 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft after failure of well-conducted medical treatment will be screened for the study.

lead_sponsor: Biobank


title: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications

acronym: FAV ss ALR

summary:
Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. The primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis.

Local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. Multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics.

Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It enables an increased flow rate at an early time fistula and faster maturation.

However, studies included low numbers of patient or are non-randomized. They cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia .

This study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia

primary_purpose: Supportive Care

location_facility: Hopital Edouard Herriot - Service Anesthésie et Réanimation


title: Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.

summary: NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.

ReferenceCitation: Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

ReferenceCitation: Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE(R) dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

ReferenceCitation: Pasman W, Wils D, Saniez MH, Kardinaal A. Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. Eur J Clin Nutr. 2006 Aug;60(8):1024-34. doi: 10.1038/sj.ejcn.1602418. Epub 2006 Feb 15.

ReferenceCitation: Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24. doi: 10.1128/AEM.71.5.2318-2324.2005.

lead_sponsor: Nealth Sarl

sponsor_collaborators:
Nealth Sarl
Roquette Freres

location_facility: Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

intervention_type: Dietary Supplement


title: Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)

acronym: TelapreVIH

summary: This phase II, multicentric, national pilot trial is designed to estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients. The primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the end of therapy (EOT).

ReferenceCitation: Cotte L, Braun J, Lascoux-Combe C, Vincent C, Valantin MA, Sogni P, Lacombe K, Neau D, Aumaitre H, Batisse D, de Truchis P, Gervais A, Michelet C, Morlat P, Vittecoq D, Rosa I, Bertucci I, Chevaliez S, Aboulker JP, Molina JM; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) HC26 Study Group. Telaprevir for HIV/hepatitis C virus-coinfected patients failing treatment with pegylated interferon/ribavirin (ANRS HC26 TelapreVIH): an open-label, single-arm, phase 2 trial. Clin Infect Dis. 2014 Dec 15;59(12):1768-76. doi: 10.1093/cid/ciu659. Epub 2014 Aug 18.

publisher_dissemination: Oxford University Press

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Janssen-Cilag Ltd.

location_facility: Service Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse


title: Preliminary Validation of the RC2S+ Therapy in Schizophrenia

summary:
Background:

Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.

New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.

The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier


acronym: LADIE

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary:
Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better

Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.

One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy.
Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis.
Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models.

EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.

The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .

ReferenceCitation: Mazieres J, Barlesi F, Rouquette I, Molinier O, Besse B, Monnet I, Audigier-Valette C, Toffart AC, Renault PA, Fraboulet S, Hiret S, Mennecier B, Debieuvre D, Westeel V, Masson P, Madroszyk-Flandin A, Pichon E, Cortot AB, Amour E, Morin F, Zalcman G, Moro-Sibilot D, Souquet PJ. Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial. Clin Cancer Res. 2020 Jul 1;26(13):3172-3181. doi: 10.1158/1078-0432.CCR-19-3056. Epub 2020 Mar 6.

publisher_dissemination: American Association for Cancer Research

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

title: Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer


title: Acute and Medium-term Effects of Neuromuscular Electrical Multisite System (Kneehab®) on Cardiovascular Parameters and Induced Muscle Fatigue in Morbidly Obese Patients: Comparison With the Unidirectional Standard Device

acronym: StimobII

summary:
The study was designed to test the following hypotheses:

In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase in muscle strength during stimulated contractions than conventional unidirectional electrostimulation session (c-NMES).

In patients with severe obesity, a six-weeks m-NMES training program will enhance cardiovascular, metabolic and inflammatory parameters.

lead_sponsor: AGIR à Dom

sponsor_collaborators:
AGIR à Dom
University Hospital, Grenoble


title: Study of the Genetic Susceptibility to Ankylosing Spondylitis by Functional Genomics Approach

acronym: GENOSPA

summary: The main objective is to identify in the candidate regions of differentially expressed genes by comparing the transcriptome of dendritic cells derived from circulating monocytes between cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and depending on haplotype association studies to correlate the differences of gene expression and genetic variations with susceptibility to AS.


title: Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years

acronym: PHIPS

summary:
Data from large prospective cohort studies of prosthetic joint infections are lacking.

Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.

Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

ReferenceCitation: Tsukayama DT, Estrada R, Gustilo RB. Infection after total hip arthroplasty. A study of the treatment of one hundred and six infections. J Bone Joint Surg Am. 1996 Apr;78(4):512-23. doi: 10.2106/00004623-199604000-00005.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Diaconesses Croix Saint-Simon Hospital Group


title: Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration

summary: The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.

ReferenceCitation: Medioni J, Brizard M, Elaidi R, Reid PF, Benlhassan K, Bray D. Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study. Contemp Clin Trials Commun. 2017 Jul 23;7:186-188. doi: 10.1016/j.conctc.2017.07.008. eCollection 2017 Sep.

ReferenceCitation: Gil-Delgado M, Paul G, Bray DH, Delgado F, Spano JP, Idbaih A, Reid PF, Benlhassan K, Diaw C, Khayat D. Continuous i.v. Crotoxin in advanced cancer: Intra-patient dose escalation. Cancer Res (2018) 78 (13_Supplement): CT071.

lead_sponsor: Celtic Biotech Ltd

sponsor_collaborators:
Celtic Biotech Ltd
Institut de Cancérologie de l'Ouest


title: Randomized Multicentric Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing

acronym: UNICOL

summary:
CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective function and restores the matrix architecture. This produces a suitable spatial environment for cells to respond properly to the cascade of signals needed for tissue regeneration to resume.

The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer healing (all ulcers treated were resistant to all other usual therapies).

Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3 months.

The aim of the study is a double blinded comparison of complete chronic corneal ulcers healing rate within 3 months in 3 groups of patient double blinded randomized between CACICOL20 instillations distribution and physiological salt solution instillations distribution.

The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete closure.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

location_facility: Centre Hospitalier Universitaire de Saint-Etiennne

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Hôpital Gabriel Montpied - CHU Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury

acronym: REPILOG

summary:
Comparison of two groups of subjets (ACL injury who return to sport) and control group non-injured about clinical and biomechanical data :

clinical test
functional test
motion analysis of 2 sport exercises
tibial translation
isokinetic evaluation

ReferenceCitation: Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.

ReferenceCitation: Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12. doi: 10.1177/0363546503261724.

ReferenceCitation: Herbst E, Hoser C, Hildebrandt C, Raschner C, Hepperger C, Pointner H, Fink C. Functional assessments for decision-making regarding return to sports following ACL reconstruction. Part II: clinical application of a new test battery. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1283-91. doi: 10.1007/s00167-015-3546-3. Epub 2015 Feb 28.

ReferenceCitation: Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29.

ReferenceCitation: Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.

ReferenceCitation: Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50. doi: 10.1249/01.MSS.0000089346.85744.D9.

ReferenceCitation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.

ReferenceCitation: Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.

lead_sponsor: University Hospital, Brest


title: Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.

summary: The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.

ReferenceCitation: Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10. doi: 10.1111/j.1525-1594.2006.00188.x.

lead_sponsor: Baxter Healthcare Corporation

sponsor_collaborators:
Baxter Healthcare Corporation
Gambro Lundia AB


title: A Phase I Dose Escalation Study of Clofarabine Given in Combination With Multi-agent Therapy for Remission Induction in Pediatric Patients With Acute Lymphoblastic Leukemia in First Relapse or Refractory to First Line Therapy -

acronym: Vandevol

summary: The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).

lead_sponsor: University Hospital, Lille

collaborators: Centre Hospitalier Universitaire de Besancon

location_facility:
Besançon University Hospital
Lille University Hospital


title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure

acronym: IVOIRE

summary: Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.

ReferenceCitation: Joannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.

oa_host_type: closed

publisher_dissemination: Springer

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Ministry of Health, France

location_country: Netherlands Belgium France

location_facility: Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux


title: Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase

acronym: REMINARY

summary: As the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, INSEE projections). The possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. The possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. In this research project, we will use the principle of neurofeedback rehabilitation (EEG) based on motor imaging with a brain-computer interface. Feedback will consist of therapeutic video games.Here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery.


title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

summary: To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

lead_sponsor: Laboratoires Thea


title: Fluid Intake During Labour, Ultrasound Evaluation

acronym: EGTO

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

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

evidence: open (via free article)

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Hopital Foch

location_facility:
Tenon
CHI Andre Gregoire
Hopital Foch


title: Translational 22q11.2:"Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11.2 Microdeletional Syndrom"

summary: The 22q11.2 microdeletion syndrome (22q11.2DS) is a rare disease with a psychiatric phenotype. Indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25 to 40% of adults carrying the 22q11DS. Thus, although this pathology has been able to provide a genetically homogeneous model for the study psychosis etiology, it is not currently possible to establish a link between genomic rearrangement and psychotic symptoms. However, this robust model of genetic vulnerability could provide us a lot of translational informations about schizophrenia genetics. To go furthermore, twin studies have provided us precious data for the study of hereditary diseases. Combining this two approaches, the translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2DS twins discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no psychiatric symptoms-.

intervention_type: Genetic


title: Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.

acronym: AGED

summary: This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

lead_sponsor: Poitiers University Hospital


title: IBD Cancer and Serious Infection in Europe

acronym: I-CARE

summary:
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

ReferenceCitation: Peyrin-Biroulet L, Rahier JF, Kirchgesner J, Abitbol V, Shaji S, Armuzzi A, Karmiris K, Gisbert JP, Bossuyt P, Helwig U, Burisch J, Yanai H, Doherty GA, Magro F, Molnar T, Lowenberg M, Halfvarson J, Zagorowicz E, Rousseau H, Baumann C, Baert F, Beaugerie L; I-CARE Collaborator Group. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2023 Mar;21(3):771-788.e10. doi: 10.1016/j.cgh.2022.09.018. Epub 2022 Sep 22.

oa_host_type: repository

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

unpaywall_oa_status: green

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives


title: Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study

acronym: EPRAC

summary: In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.

lead_sponsor: University Hospital, Montpellier

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: EPRAC

titre: Prédiction par échographie de l'échec du cathétérisme artériel radial chez les patients opérés d'une chirurgie cardiaque ou aortique : une étude prospective.

discipline_principale: anesthésiologie / réanimation

nom_porteur: PANIEGO

prenom_porteur: Jérôme


title: Evaluation of the Efficacy on Urinary Continence and Quality of Life of the Sub-urethral Tape I-STOP® Using the Transobturator and Perineal Route on Male Incontinent After Radical Prostatectomy.

summary: The main objective is to evaluate the clinical efficacy on continence, quality of life and tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence significant and embarrassing after a radical prostatectomy.

lead_sponsor: CL Medical


title: Retinal Neurodegenerative Signs in Alzheimer's Diseases

acronym: SIGNAL

summary:
A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.

Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.

It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.


title: Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost

acronym: B-BOOST

summary:
HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer.

However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

ReferenceCitation: Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
MCM Vaccines B.V.

location_facility: Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital


title: Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy

summary: The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.

lead_sponsor: Air Liquide SA


title: Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test

acronym: EDUCANCOLAGE

summary:
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.

The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.

The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.

The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
University Hospital, Angers
Nantes University Hospital
Centre Hospitalier de Dreux
Hospital BLOIS
Hospital LOCHES
Poitiers University Hospital
UNIVERSITY HOSPITAL, ORLEANS
Clinic LE MANS

location_facility: Service d'Hépatogastro-entérologie CHU de NANTES

location_facility: Service d'Hépatogastro-entérologie CHG BLOIS

location_facility: Service d'Hépatogastro-entérologie CHU POITIERS

location_facility: Service d'Hépatogastro-entérologie CHR d'Orléans

location_facility: Service d'Hépatogastro-entérologie CHU ANGERS

location_facility: Service d'Hépatogastro-entérologie CHRU de TOURS

location_facility: Service d'Hépatogastro-entérologie CHG de DREUX


title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

acronym: Phoenix

summary:
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

lead_sponsor: Eli Lilly and Company

location_country: Netherlands France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics

acronym: AO-IFAB

summary:
Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by severe pain, loss of autonomy, diminished health-related quality of life, functional disability and diminished physical ability to fulfill occupational duties of life in its end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and total ankle replacement. Despite the good pain relief provided by these procedures, patients are still experiencing post-operatively important functional limitations in their activities of the daily living which affect their independency and quality of life. In order to remain capable of performing primary activities of the daily living, those patients have to make functional compensatory adaptations in the ipsilateral adjacent joints that will cause additional degenerative joint disease in those joints.

Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic and questionnaire outcomes. However, these outcome measures have been criticized for not being sensitive enough to detect clinically meaningful change in foot function. To tackle these shortcomings, an advanced clinical examination platform integrating pressure-force-kinematic measurement devices was developed and showed its clinical value for the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has included this integrated use of three-dimensional multi-segment foot models, plantar pressure platform and a force platform to report on the functional outcome of an ankle arthrodesis or a total ankle replacement.

Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both centres are equipped with the same advanced clinical examination platform. It is believed that proposed approach has the potential to provide further insight in the true functional changes related to ankle arthrodesis and total ankle replacement. This may in turn result in improved rehabilitation, less risk for post-operative complications, earlier discharge and quicker resumption of normal activities of the daily living, which would make ankle arthrodesis and total ankle replacement more cost-efficient and could potentially affect thousands of patients each year. Therefore, the hypotheses of the present study are:

Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.
Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study

acronym: PREIMAPED

summary: Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.


title: Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)

summary:
The DEFI-1 study recruited 625 women witnesses and 299 of their spouses. With regard to case couples, 271 cases were recruited from the spontaneous repeated miscarriages (SRM) subgroup (≥3 spontaneous miscarriage (SM) from trimester 1 of pregnancy) and 93 from the unexplained fetal death in utero (FDIU) subgroup from trimesters 2 and 3 of pregnancy.

The main objective of the DEFI 2 study is to increase the number of case-pairs in these 2 particular subgroups to replicate the results of the genetic determinants highlighted from cases and controls with extreme phenotypes and obtain a sufficient number of women with FDIUs to identify specific determinants.


title: (DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.

acronym: (DIS)AGREE

summary:
In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Hôpital Lariboisière_APHP - Réanimation Chirurgicale Polyvalente

location_facility: Hôpital Beaujon - Réanimation hépato-digestive

location_facility: CHU de Toulouse-Rangueil - Réanimation Polyvalente

location_facility: GHEF (Grand Hôpital de l'Est Francilien)-Site de Marne la Vallée

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: Hôpital Beaujon - Réanimation chirurgicale polyvalente


title: An Exploratory Study of the Feasibility of the Installation by a Paramedical Staff of a Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

summary: The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

location_facility: Service de neurologie motricité,Hôpital Pellegrin


title: Effect of a New Graphically Modified Nutri-Score on the Objective Understanding of Foods' Nutritional Quality and Ultra-processing - a Randomised Controlled Trial

summary: A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

lead_sponsor: University of Paris 13

location_facility: Equipe de recherche en Epidémiologie nutritionnelle


title: EEG and Behavioral Correlates of Temporal Prediction in the Tactile Modality in Schizophrenia

acronym: SchizPredicT

summary:
Patients with schizophrenia have disturbances in their sense of self, particularly their bodily self. Disorders of the sense of self are central to schizophrenia and are of interest because they are thought to be present prior to the development of the disorder, when only a few attenuated symptoms signal a risk of developing psychosis. Finding markers related to the sense of self would make it possible to predict which subjects, among those with minimal psychotic symptoms, will develop psychosis, and thus to better adapt management. Disturbances in the experience of the passage of time that accompany disturbances in the sense of self have been described particularly in subjects at risk of developing psychosis, and would predict the onset of the pathology. However, as with alterations in the sense of self, it can be difficult to get patients to describe their disturbances in the experience of time, and objective measures are required to facilitate detection of these disturbances. In the present protocol an objective measure of temporal perception mechanisms will be tested in relation to the sense of self.

The tests used in the protocol assess subjects' abilities to benefit from the passage of time and to use these abilities to predict and prepare for the occurrence of an event. The investigators have previously shown that patients with impaired bodily sense of self do not benefit from the passage of time to prepare themselves to process information in the future. The present protocol is aimed at developing a measure more sensitive to the patients' disorders by adding tactile measures.

primary_purpose: Basic Science

lead_sponsor: Centre Psychothérapique de Nancy


title: Prospective KTD-innov Cohort of Kidney Transplants Patients

acronym: KTD-innov

summary:
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.

the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Cohort of Patients Naive of Antiretroviral Treatment at Enrollment

acronym: COPANA

summary: The purpose of this study is to evaluate the short, medium and long-term prognosis for newly diagnosed HIV patients.

ReferenceCitation: Boufassa F, Goujard C, Viard JP, Carlier R, Lefebvre B, Yeni P, Bouchaud O, Capeau J, Meyer L, Vigouroux C; ANRS COPANA Cohort Study Group. Immune deficiency could be an early risk factor for altered insulin sensitivity in antiretroviral-naive HIV-1-infected patients: the ANRS COPANA cohort. Antivir Ther. 2012;17(1):91-100. doi: 10.3851/IMP1916.

ReferenceCitation: Dray-Spira R, Legeai C, Le Den M, Boue F, Lascoux-Combe C, Simon A, May T, Goujard C, Meyer L; ANRS-COPANA Cohort Study Group. Burden of HIV disease and comorbidities on the chances of maintaining employment in the era of sustained combined antiretoviral therapies use. AIDS. 2012 Jan 14;26(2):207-15. doi: 10.1097/QAD.0b013e32834dcf61.

ReferenceCitation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

ReferenceCitation: Krastinova E, Seng R, Yeni P, Viard JP, Vittecoq D, Lascoux-Combe C, Fourn E, Pahlavan G, Delfraissy JF, Goujard C, Meyer L; ANRS PRIMO and COPANA Cohorts. Is clinical practice concordant with the changes in guidelines for antiretroviral therapy initiation during primary and chronic HIV-1 infection? The ANRS PRIMO and COPANA cohorts. PLoS One. 2013 Aug 1;8(8):e71473. doi: 10.1371/journal.pone.0071473. Print 2013. Erratum In: PLoS One. 2013;8(11). doi:10.1371/annotation/aed12a66-9c76-4e49-806b-881a2fe23bba. Goujard, Cecile [added].

ReferenceCitation: Legeai C, Vigouroux C, Souberbielle JC, Bouchaud O, Boufassa F, Bastard JP, Carlier R, Capeau J, Goujard C, Meyer L, Viard JP; ANRS-COPANA Cohort Study Group. Associations between 25-hydroxyvitamin D and immunologic, metabolic, inflammatory markers in treatment-naive HIV-infected persons: the ANRS CO9 <<COPANA>> cohort study. PLoS One. 2013 Sep 18;8(9):e74868. doi: 10.1371/journal.pone.0074868. eCollection 2013.

ReferenceCitation: Boufassa F, Lechenadec J, Meyer L, Costagliola D, Hunt PW, Pereyra F, Deeks S, Pancino G, Taulera O, Lichterfeld M, Delobel P, Saez-Cirion A, Lambotte O; ANRS CO18 HIV Controllers Cohort; Cascade Collaboration in Eurocoord; SCOPE Cohort; International HIV Controllers Study. Blunted response to combination antiretroviral therapy in HIV elite controllers: an international HIV controller collaboration. PLoS One. 2014 Jan 17;9(1):e85516. doi: 10.1371/journal.pone.0085516. eCollection 2014.

ReferenceCitation: El Khoury P, Ghislain M, Villard EF, Le Goff W, Lascoux-Combe C, Yeni P, Meyer L, Vigouroux C, Goujard C, Guerin M. Plasma cholesterol efflux capacity from human THP-1 macrophages is reduced in HIV-infected patients: impact of HAART. J Lipid Res. 2015 Mar;56(3):692-702. doi: 10.1194/jlr.M054510. Epub 2015 Jan 8.

ReferenceCitation: Ghislain M, Bastard JP, Meyer L, Capeau J, Fellahi S, Gerard L, May T, Simon A, Vigouroux C, Goujard C; ANRS-COPANA Cohort Study Group. Late Antiretroviral Therapy (ART) Initiation Is Associated with Long-Term Persistence of Systemic Inflammation and Metabolic Abnormalities. PLoS One. 2015 Dec 4;10(12):e0144317. doi: 10.1371/journal.pone.0144317. eCollection 2015.

ReferenceCitation: Ploquin MJ, Madec Y, Casrouge A, Huot N, Passaes C, Lecuroux C, Essat A, Boufassa F, Jacquelin B, Jochems SP, Petitjean G, Angin M, Gartner K, Garcia-Tellez T, Noel N, Booiman T, Boeser-Nunnink BD, Roques P, Saez-Cirion A, Vaslin B, Dereudre-Bosquet N, Barre-Sinoussi F, Ghislain M, Rouzioux C, Lambotte O, Albert ML, Goujard C, Kootstra N, Meyer L, Muller-Trutwin MC. Elevated Basal Pre-infection CXCL10 in Plasma and in the Small Intestine after Infection Are Associated with More Rapid HIV/SIV Disease Onset. PLoS Pathog. 2016 Aug 10;12(8):e1005774. doi: 10.1371/journal.ppat.1005774. eCollection 2016 Aug.


title: Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging

acronym: NAVEOS

summary: Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery: Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of hip navigation in lateral decubitus while maintaining the accuracy of the technique

location_facility: Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin