type: Registry Identifier

title: Study of Immune Tolerance and Capacity for Wound Healing of Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)

acronym: RDEB

summary:
Recessive Dystrophic Epidermolysis Bullosa (RDEB) is one of the most severe rare inherited skin disorders affecting children and adults. Current medical care protocols for RDEB patients are limited to palliative procedures to treat blistering and erosive lesions, wounds, and severe local and systemic complications such as fusion and contracture of the digits, skin cancer, esophageal stricture, severe anemia, infections, malnutrition and growth retardation. However, current medical treatments still cannot prevent the recurrence of the lesions arising from defective expression of type VII collagen (COL7A1), the main constituent of anchoring fibrils which form essential structures for dermal-epidermal adherence.

The purpose of this study is to investigate the capacity of keratinocytes and fibroblasts to repair skin wounds in patients suffering from Recessive Dystrophic Epidermolysis Bullosa (RDEB).

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

location_country:
United Kingdom
France

location_facility: Inserm U781 Service de Génétique Necker Hospital for sick children

location_facility: Service de dermatologie Necker Hospital for sick children

location_facility: Guy's and ST Thomas NHS Foundation trust/Guy's Hospital


type: EudraCT Number

title: An Open-Label, Multicenter, Phase III Study to Assess the Impact of Transient Androgenic Deprivation With Enantone LP 11.25 Mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

summary: The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Takeda

location_facility:
Ouzid, Paris La Défense,
Tenon Hospital Paris France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint: a Randomized, Open Label, Non-inferiority Trial

acronym: SHASAR

summary: In France, the incidence of native joint infections is about 10 per 100 000 person-years, most commonly caused by S.aureus followed by b-haemolytic streptococci. French and international antibiotic guidelines, based on expert advice and retrospective studies, recommend intravenous antibiotics for two weeks, then oral for 4 weeks without evident link between intravenous, prolonged oral treatment and cure. Long term exposure to antibiotics increases bacterial resistance, a major problem of public health. Several studies show that serious infectious can be treated safely by a shorter treatment and with oral antibiotics. There is no randomized controlled trial to establish the duration of antibiotics in native joint infections. Moreover, no consensus prevails on the administration route and duration of antimicrobial therapy. Although most clinicians acknowledge the interest of oral antibiotics and shorter treatment duration, randomized controlled trials are necessary to evaluate this practice. The SHASAR project aims to evaluate whether a shorter antibiotic treatment (3 week treatment) is safe and not inferior to the conventional 6 week treatment in native joint infections. If successful, this would represent a major advance in terms of patients' quality of life; decreased rate of health-care-related infections and complications, bacterial resistance and cost.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Henri Mondor - Service de Maladies Infectieuses

location_facility: CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie

location_facility: CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses

location_facility: Hôpital Avicenne - Service de Maladies Infectieuses

location_facility: Hôpital Pitié Salpetrière - Service de Rhumatologie

location_facility: Hôpital Cochin - Service de Rhumatologie

location_facility: Hôpital Henri Mondor - Service de Rhumatologie

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses

location_facility: Hôpital Necker - Service de Maladies Infectieuses

location_facility: Hôpital Antoine Béclère - Service de Maladies Infectieuses

location_facility: Hôpital Bichat - Service de Maladies Infectieuses

location_facility: Hôpital Lariboisière Service de Rhumatologie

location_facility: CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie

location_facility: GH Diaconesse La Croix St Simon - Service de Rhumatologie

location_facility: CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses

location_facility: Hôpitaux de Brabois - Service de Maladies Infectieuses

location_facility: CHU Tours - Hôpital Trousseau - Service de Rhumatologie

location_facility: CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie

location_facility: Hôpital Cochin - Service de Maladies Infectieuses

location_facility: Hôpital Pitié Salpetrière - Service de Maladies Infectieuses

location_facility: Hôpital Saint Antoine - Service de Rhumatologie

location_facility: Hôpital Tenon - Service de Maladies Infectieuses

location_facility: Hôpital Ambroise Paré - Service de Rhumatologie

location_facility: CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie

location_facility: CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses

location_facility: Hôpital Bichat - Service de Rhumatologie

location_facility: Hôpital Avicenne - Service de Rhumatologie

location_facility: Hôpital Raymond Poincaré - Service de Maladies Infectieuses

location_facility: Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Sud Rennes - Service de Rhumatologie

location_facility: Hôpital Cavale Blanche - Service de Maladies Infectieuses

location_facility: Hôpitaux de Brabois - Service de Rhumatologie

location_facility: Hôpital Pellegrin Bordeaux - Service de Rhumatologie

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: SHASAR

titre: Traitement antibiotique court de trois semaines versus six semaines dans les arthrites septiques sans matériel de l'adulte : essai randomisé ouvert de non infériorité

discipline_principale: rhumatologie

nom_porteur: Escaut

prenom_porteur: Lelia


title: Pneumonia Due to Stenotrophomonas Maltophilia in Intensive Care Units: a Multicentre Retrospective Study

acronym: RETROSTENO

summary:
Pneumonia is a major cause of ICU admission, or may complicate ICU course. Among the causative pathogens, Stenotrophomonas Maltophilia is a rare pathogen, but affects usually patients with chronic pulmonary co-morbidities, or with long duration of mechanical ventilation and multiples treatment with broad spectrum antimicrobial therapy. However, there are only a paucity of data regarding epidemiology, impact and outcome of Pneumonia due to Stenotrophomonas Maltophilia in critically ill patients.

Primary objective was to study factors associated with mortality in case of Pneumonia due to Stenotrophomonas Maltophilia. Secondary objectives were to describe factors associated with morbidity of Pneumonia due to Stenotrophomonas Maltophilia (duration of mechanical ventilation, ICU length of stay), and to report the characteristics of critically ill patients presenting Pneumonia due to Stenotrophomonas Maltophilia.

status: Unknown status

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Guerci P, Bellut H, Mokhtari M, Gaudefroy J, Mongardon N, Charpentier C, Louis G, Tashk P, Dubost C, Ledochowski S, Kimmoun A, Godet T, Pottecher J, Lalot JM, Novy E, Hajage D, Bougle A; AZUREA research network. Outcomes of Stenotrophomonas maltophilia hospital-acquired pneumonia in intensive care unit: a nationwide retrospective study. Crit Care. 2019 Nov 21;23(1):371. doi: 10.1186/s13054-019-2649-5.

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Anesthesiology and Critical Care Medicine, Groupe Hospitalier Pitié-Salpêtrière

location_facility: Department of Anesthesiology and Critical Care Medicine, University Hospital of Strasbourg

location_facility: Réanimation Polyvalente CHR Metz-Thionville

location_facility: Department of Anesthesiology and Critical Care Medicine, University Hospital of NANCY

status_simplified: Unknown


title: Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

acronym: XAPAEDUS

summary:
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).

VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.

Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.

The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.

The main information that researchers will collect in this study:

Age, gender, and other information about the child and their illness
Type of VTE treatment given to the child
Occurrence of medically important bleeding and its severity

Further information that researchers will collect:

Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
Return of VTE symptoms
Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.

The data for this study will be collected from electronic health records and health insurance claims data until 2026.

Researchers will observe each child during treatment until:

end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
their information is no longer available, or
the study ends.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country: Denmark Sweden Spain France


title: An International Multicenter Phase II Randomised Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy

acronym: VERITAS

summary: The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

status: Terminated

ipd_sharing: Yes

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Italy Netherlands Austria Spain France

location_facility: Fondazione IRCCS Istituto nazionaleTumori

location_facility: Hospital Universitario y policnico La Fe


acronym: HTLP-ONCO

summary: This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.

location_facility: Hematology department / Necker Children's Hospital

location_facility: Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux

title: A Phase I/II Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies

source: euctr


title: INVIBO: Evaluation of the Feasibility and Tolerance of an Intubation Procedure Performed by Means of the Bonfils Fiberscope in Awake Patients With Predicted Difficult Intubation in the Context of ENT Cancer Surgery

acronym: INVIBO

summary:
The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the study was to evaluate the feasibility and the tolerance of an intubation procedure realized by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI), in the context of ENT cancer surgery.

The intubation is performed under local anesthesia (either nasal, oral, or intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation. The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be both successful (≤ 2 attempts and duration < 180 sec) and well tolerated (Fahey score < 2). The secondary endpoints include the difficulties met by the operator during the BFI and patient's perception of the intubation procedure, evaluated in the recovery room and 7 days after the intervention. Sample size is calculated using a one-stage Fleming design with p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.

ReferenceType: background

ReferenceCitation: Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021. Erratum In: Anesthesiology 1993 Jan;78(1):224.

ReferenceCitation: Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.

ReferenceCitation: Boisson-Bertrand D, Bourgain JL, Camboulives J, Crinquette V, Cros AM, Dubreuil M, Eurin B, Haberer JP, Pottecher T, Thorin D, Ravussin P, Riou B. [Difficult intubation. French Society of Anesthesia and Intensive Care. A collective expertise]. Ann Fr Anesth Reanim. 1996;15(2):207-14. No abstract available. French.

ReferenceCitation: Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91. doi: 10.1046/j.1365-2044.2003.03407.x.

ReferenceCitation: Bein B, Worthmann F, Scholz J, Brinkmann F, Tonner PH, Steinfath M, Dorges V. A comparison of the intubating laryngeal mask airway and the Bonfils intubation fibrescope in patients with predicted difficult airways. Anaesthesia. 2004 Jul;59(7):668-74. doi: 10.1111/j.1365-2044.2004.03778.x.

ReferenceCitation: Bein B, Yan M, Tonner PH, Scholz J, Steinfath M, Dorges V. Tracheal intubation using the Bonfils intubation fibrescope after failed direct laryngoscopy. Anaesthesia. 2004 Dec;59(12):1207-9. doi: 10.1111/j.1365-2044.2004.03967.x.

ReferenceCitation: Fahey MR, Morris RB, Miller RD, Sohn YJ, Cronnelly R, Gencarelli P. Clinical pharmacology of ORG NC45 (NorcuronTM): a new nondepolarizing muscle relaxant. Anesthesiology. 1981 Jul;55(1):6-11. doi: 10.1097/00000542-198107000-00003.

ReferenceCitation: Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

ReferenceCitation: Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.

ReferenceCitation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.

ReferenceCitation: Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.

ReferenceCitation: Loh KS, Irish JC. Traumatic complications of intubation and other airway management procedures. Anesthesiol Clin North Am. 2002 Dec;20(4):953-69. doi: 10.1016/s0889-8537(02)00022-6.

ReferenceCitation: Mazeres JE, Lefranc A, Cropet C, Steghens A, Bachmann P, Perol O, Rosay H. Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer. Eur J Anaesthesiol. 2011 Sep;28(9):646-50. doi: 10.1097/EJA.0b013e3283495b85.

lead_sponsor: Centre Leon Berard

intervention_type: Device


title: A Prospective Clinical Investigation Evaluating the Safety and Effectiveness of FASY L Hyaluronic Acid Gel for the Treatment of Lip Deformity

acronym: FENTHA

summary: Early postnatal repair of cleft lip and palate aims at the development of the child through reconstruction of the face soon after birth. Cleft lip is the result of a defect in the fusion of the buds of the face by default of cell apoptosis of the embryonic neural crest constituting the skin and the labial mucosa. Lip surgery or cheiloplasty primary of unilateral and bilateral cleft lip and palate is carried out from the age of 6 weeks. At the end of the surgical treatment, we often observe small unsightly residual volumetric asymmetries. The choice is then either to surgically reduce a muscular part too voluminous by reducing locally the volume of the lip, or to increase the volume of the thinnest portion this second solution is made possible either by injecting fat or by injection of hyaluronic acid. By adulthood, patients with cleft lip have often undergone 10 or more defect-related surgeries and many desire less invasive options to improve any residual cosmetic imperfections. The first use of a temporary alloplastic injectable soft tissue filler, hyaluronic acid (HA), for upper lip augmentation in a patient with asymmetry after surgical cleft lip repair was reported in 2008. There are few publications on the use hyaluronic acid in complement to the surgical treatment of cleft lip and palate, but all reported promising results.

lead_sponsor: Symatese

sponsor_collaborators: Symatese EVAMED

location_facility:
Hôpital Roger Salengro
Cabinet médical


title: Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales

acronym: WIVOP-Scales

summary: The aim of this study is to evaluate the diagnostic performance of Withings bathroom scales WBS08 and WBS12 to measure PWV (Pulse Wave Velocity).

time_perspective: Prospective

lead_sponsor: Withings

location_facility:
Georges Pompidou European Hospital
CHU Grenoble


title: Neuro-feedback Therapy for Treating Tinnitus : Efficacy Pilot Study on a Targeted Population

acronym: TNTA

summary: Neuro-feedback for treating tinnitus seem to be a promising approach to help people suffering from chronic tinnitus. The past studies on this approach suffered interindividual variability in their results. The investigators' current hypothesis is that the variability of the results is the consequences of two possible flaws: lack of appropriate patient selection and lack of support of the patient during the therapy. This study is aimed at testing these hypotheses.

ReferenceCitation: Crocetti A, Forti S, Del Bo L. Neurofeedback for subjective tinnitus patients. Auris Nasus Larynx. 2011 Dec;38(6):735-8. doi: 10.1016/j.anl.2011.02.003. Epub 2011 May 17.

ReferenceCitation: Dohrmann K, Weisz N, Schlee W, Hartmann T, Elbert T. Neurofeedback for treating tinnitus. Prog Brain Res. 2007;166:473-85. doi: 10.1016/S0079-6123(07)66046-4.

ReferenceCitation: Hartmann T, Lorenz I, Muller N, Langguth B, Weisz N. The effects of neurofeedback on oscillatory processes related to tinnitus. Brain Topogr. 2014 Jan;27(1):149-57. doi: 10.1007/s10548-013-0295-9. Epub 2013 May 23.

ReferenceCitation: Guillard R, Fraysse MJ, Simeon R, Cervoni T, Schmutz J, Piedfort B, Ferat V, Congedo M, Londero A. A portable neurofeedback device for treating chronic subjective tinnitus: Feasibility and results of a pilot study. Prog Brain Res. 2021;260:167-185. doi: 10.1016/bs.pbr.2020.08.001. Epub 2020 Oct 14.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

version: submittedVersion

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: Zeta Technologies

sponsor_collaborators:
Zeta Technologies
University Hospital, Toulouse

location_facility:
Purpan University hospital
Audika Research Center


title: Comparison of the Analgesic Effect Between the Motor Cortex Stimulation (tDCS and rTMS) and the Trans-spinal Stimulation (tsDCS ) in the Algoneurodystrophy of Members. A Randomised Clinical Trial. tDCS : Transcranial Direct-current Stimulation rTMS : Repetitive Transcranial Magnetic Stimulation tsDCS : Transcutaneous Spinal Direct Current Stimulation

acronym: ALGOSTIM

summary: The purpose of this study is to compare the analgesic effectiveness of two motor cortex neurostimulations (tDCS and rTMS) and the trans-spinal neurostimulation (tsDCS ) in the algoneurodystrophy.

ReferenceCitation: Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74. doi: 10.1212/01.wnl.0000242731.10074.3c.

ReferenceCitation: de Andrade DC, Mhalla A, Adam F, Texeira MJ, Bouhassira D. Neuropharmacological basis of rTMS-induced analgesia: the role of endogenous opioids. Pain. 2011 Feb;152(2):320-326. doi: 10.1016/j.pain.2010.10.032. Epub 2010 Dec 10.

ReferenceCitation: Lefaucheur JP, Andre-Obadia N, Poulet E, Devanne H, Haffen E, Londero A, Cretin B, Leroi AM, Radtchenko A, Saba G, Thai-Van H, Litre CF, Vercueil L, Bouhassira D, Ayache SS, Farhat WH, Zouari HG, Mylius V, Nicolier M, Garcia-Larrea L. [French guidelines on the use of repetitive transcranial magnetic stimulation (rTMS): safety and therapeutic indications]. Neurophysiol Clin. 2011 Dec;41(5-6):221-95. doi: 10.1016/j.neucli.2011.10.062. Epub 2011 Nov 10. French.

ReferenceCitation: Lefaucheur JP, Menard-Lefaucheur I, Goujon C, Keravel Y, Nguyen JP. Predictive value of rTMS in the identification of responders to epidural motor cortex stimulation therapy for pain. J Pain. 2011 Oct;12(10):1102-11. doi: 10.1016/j.jpain.2011.05.004. Epub 2011 Jul 31.

ReferenceCitation: Lefaucheur, J. P. (2007).

ReferenceCitation: Khedr EM, Kotb H, Kamel NF, Ahmed MA, Sadek R, Rothwell JC. Longlasting antalgic effects of daily sessions of repetitive transcranial magnetic stimulation in central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):833-8. doi: 10.1136/jnnp.2004.055806.

ReferenceCitation: Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P, Perrot S, Januel D, Bouhassira D. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.

ReferenceCitation: Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

ReferenceCitation: Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.

ReferenceCitation: Lefaucheur JP. Use of repetitive transcranial magnetic stimulation in pain relief. Expert Rev Neurother. 2008 May;8(5):799-808. doi: 10.1586/14737175.8.5.799.

ReferenceCitation: Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.

ReferenceCitation: Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.

ReferenceCitation: Medeiros LF, de Souza IC, Vidor LP, de Souza A, Deitos A, Volz MS, Fregni F, Caumo W, Torres IL. Neurobiological effects of transcranial direct current stimulation: a review. Front Psychiatry. 2012 Dec 28;3:110. doi: 10.3389/fpsyt.2012.00110. eCollection 2012.

ReferenceCitation: Thibaut A, Chatelle C, Gosseries O, Laureys S, Bruno MA. [Transcranial direct current stimulation: a new tool for neurostimulation]. Rev Neurol (Paris). 2013 Feb;169(2):108-20. doi: 10.1016/j.neurol.2012.05.008. Epub 2012 Sep 7. French.

ReferenceCitation: Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

ReferenceCitation: Antal A, Kriener N, Lang N, Boros K, Paulus W. Cathodal transcranial direct current stimulation of the visual cortex in the prophylactic treatment of migraine. Cephalalgia. 2011 May;31(7):820-8. doi: 10.1177/0333102411399349. Epub 2011 Mar 11.

ReferenceCitation: Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.

ReferenceCitation: Mori F, Codeca C, Kusayanagi H, Monteleone F, Buttari F, Fiore S, Bernardi G, Koch G, Centonze D. Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. J Pain. 2010 May;11(5):436-42. doi: 10.1016/j.jpain.2009.08.011. Epub 2009 Dec 16.

ReferenceCitation: Antal A, Terney D, Kuhnl S, Paulus W. Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010 May;39(5):890-903. doi: 10.1016/j.jpainsymman.2009.09.023.

ReferenceCitation: O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. A report of a Cochrane systematic review and meta-analysis. Eur J Phys Rehabil Med. 2011 Jun;47(2):309-26. Epub 2011 Apr 14.

ReferenceCitation: Zaghi S, Thiele B, Pimentel D, Pimentel T, Fregni F. Assessment and treatment of pain with non-invasive cortical stimulation. Restor Neurol Neurosci. 2011;29(6):439-51. doi: 10.3233/RNN-2011-0615.

ReferenceCitation: Luedtke K, Rushton A, Wright C, Geiss B, Juergens TP, May A. Transcranial direct current stimulation for the reduction of clinical and experimentally induced pain: a systematic review and meta-analysis. Clin J Pain. 2012 Jun;28(5):452-61. doi: 10.1097/AJP.0b013e31823853e3.

ReferenceCitation: O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD008208. doi: 10.1002/14651858.CD008208.pub3.

ReferenceCitation: Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.

ReferenceCitation: Truini A, Vergari M, Biasiotta A, La Cesa S, Gabriele M, Di Stefano G, Cambieri C, Cruccu G, Inghilleri M, Priori A. Transcutaneous spinal direct current stimulation inhibits nociceptive spinal pathway conduction and increases pain tolerance in humans. Eur J Pain. 2011 Nov;15(10):1023-7. doi: 10.1016/j.ejpain.2011.04.009. Epub 2011 May 14.

ReferenceCitation: Toshev PK, Guleyupoglu B, Bikson M. Informing dose design by modeling transcutaneous spinal direct current stimulation. Clin Neurophysiol. 2014 Nov;125(11):2147-2149. doi: 10.1016/j.clinph.2014.03.022. Epub 2014 Apr 4. No abstract available.

ReferenceCitation: Priori A, Ciocca M, Parazzini M, Vergari M, Ferrucci R. Transcranial cerebellar direct current stimulation and transcutaneous spinal cord direct current stimulation as innovative tools for neuroscientists. J Physiol. 2014 Aug 15;592(16):3345-69. doi: 10.1113/jphysiol.2013.270280. Epub 2014 Jun 6.

ReferenceCitation: Cogiamanian F, Ardolino G, Vergari M, Ferrucci R, Ciocca M, Scelzo E, Barbieri S, Priori A. Transcutaneous spinal direct current stimulation. Front Psychiatry. 2012 Jul 4;3:63. doi: 10.3389/fpsyt.2012.00063. eCollection 2012.

ReferenceCitation: Plow EB, Pascual-Leone A, Machado A. Brain stimulation in the treatment of chronic neuropathic and non-cancerous pain. J Pain. 2012 May;13(5):411-24. doi: 10.1016/j.jpain.2012.02.001. Epub 2012 Apr 7.

ReferenceCitation: Lefaucheur JP, Antal A, Ahdab R, Ciampi de Andrade D, Fregni F, Khedr EM, Nitsche M, Paulus W. The use of repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) to relieve pain. Brain Stimul. 2008 Oct;1(4):337-44. doi: 10.1016/j.brs.2008.07.003. Epub 2008 Oct 7.

ReferenceCitation: Fregni F, Freedman S, Pascual-Leone A. Recent advances in the treatment of chronic pain with non-invasive brain stimulation techniques. Lancet Neurol. 2007 Feb;6(2):188-91. doi: 10.1016/S1474-4422(07)70032-7.

ReferenceCitation: Nizard J, Lefaucheur JP, Helbert M, de Chauvigny E, Nguyen JP. Non-invasive stimulation therapies for the treatment of refractory pain. Discov Med. 2012 Jul;14(74):21-31.

ReferenceCitation: Mhalla A, Baudic S, de Andrade DC, Gautron M, Perrot S, Teixeira MJ, Attal N, Bouhassira D. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia. Pain. 2011 Jul;152(7):1478-1485. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.

ReferenceCitation: Zaghi S, DaSilva AF, Acar M, Lopes M, Fregni F. One-year rTMS treatment for refractory trigeminal neuralgia. J Pain Symptom Manage. 2009 Oct;38(4):e1-5. doi: 10.1016/j.jpainsymman.2009.04.020. Epub 2009 Aug 26. No abstract available. Erratum In: J Pain Symptom Manage. 2010 Dec;40(6):e9.

ReferenceCitation: Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Nguyen JP. Neuropathic pain controlled for more than a year by monthly sessions of repetitive transcranial magnetic stimulation of the motor cortex. Neurophysiol Clin. 2004 Apr;34(2):91-5. doi: 10.1016/j.neucli.2004.02.001.

ReferenceCitation: Hodaj H, Alibeu JP, Payen JF, Lefaucheur JP. Treatment of Chronic Facial Pain Including Cluster Headache by Repetitive Transcranial Magnetic Stimulation of the Motor Cortex With Maintenance Sessions: A Naturalistic Study. Brain Stimul. 2015 Jul-Aug;8(4):801-7. doi: 10.1016/j.brs.2015.01.416. Epub 2015 Feb 7.

ReferenceCitation: Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.

ReferenceCitation: Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

ReferenceCitation: Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

ReferenceCitation: Picarelli H, Teixeira MJ, de Andrade DC, Myczkowski ML, Luvisotto TB, Yeng LT, Fonoff ET, Pridmore S, Marcolin MA. Repetitive transcranial magnetic stimulation is efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain. 2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.

ReferenceCitation: M. Sorel, J.-P. Lefaucheur, J.-C. Beatrix, A.M. Domec, M.L. Giboutet, E. Houy, J. Robert, P. Cesaro (2012); Complex regional pain syndrome: interest in coupling the vascular phase of technetium 99 bone scintigraphy with the effectiveness of ketamine. Lett. Méd. Phys. Réadapt., OI 10.1007/s11659-012-0296-1

lead_sponsor: University Hospital, Grenoble

location_facility: Centre de la douleur, CHU Grenoble Alpes

location_facility: Service de Physiologie - Explorations Fonctionnelles, Hôpital Henri Mondor


title: ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD

summary:
Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.

The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )

location_facility:
Assistance Publique-Hopitaux de Paris
Hopital Henri Mondor


title: Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

summary: The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

ReferenceCitation: Lie SO, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Gustafsson G. A population-based study of 272 children with acute myeloid leukaemia treated on two consecutive protocols with different intensity: best outcome in girls, infants, and children with Down's syndrome. Nordic Society of Paediatric Haematology and Oncology (NOPHO). Br J Haematol. 1996 Jul;94(1):82-8. doi: 10.1046/j.1365-2141.1996.d01-1761.x.

ReferenceCitation: Wells RJ, Woods WG, Buckley JD, Odom LF, Benjamin D, Bernstein I, Betcher D, Feig S, Kim T, Ruymann F, et al. Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study. J Clin Oncol. 1994 Nov;12(11):2367-77. doi: 10.1200/JCO.1994.12.11.2367.

ReferenceCitation: Lipshultz SE, Colan SD, Gelber RD, Perez-Atayde AR, Sallan SE, Sanders SP. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med. 1991 Mar 21;324(12):808-15. doi: 10.1056/NEJM199103213241205.

ReferenceCitation: Mertens AC, Wen W, Davies SM, Steinbuch M, Buckley JD, Potter JD, Robison LL. Congenital abnormalities in children with acute leukemia: a report from the Children's Cancer Group. J Pediatr. 1998 Nov;133(5):617-23. doi: 10.1016/s0022-3476(98)70100-3.

ReferenceCitation: Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. doi: 10.1200/JCO.1997.15.4.1544.

ReferenceCitation: Behar C, Suciu S, Benoit Y, Robert A, Vilmer E, Boutard P, Bertrand Y, Lutz P, Ferster A, Tokaji E, Manel AM, Solbu G, Otten J. Mitoxantrone-containing regimen for treatment of childhood acute leukemia (AML) and analysis of prognostic factors: results of the EORTC Children Leukemia Cooperative Study 58872. Med Pediatr Oncol. 1996 Mar;26(3):173-9. doi: 10.1002/(SICI)1096-911X(199603)26:33.0.CO;2-H.

ReferenceCitation: Burnett AK, Goldstone AH, Stevens RM, Hann IM, Rees JK, Gray RG, Wheatley K. Randomised comparison of addition of autologous bone-marrow transplantation to intensive chemotherapy for acute myeloid leukaemia in first remission: results of MRC AML 10 trial. UK Medical Research Council Adult and Children's Leukaemia Working Parties. Lancet. 1998 Mar 7;351(9104):700-8. doi: 10.1016/s0140-6736(97)09214-3.

ReferenceCitation: Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cycles of high-dose cytarabine are administered. J Clin Oncol. 1999 Dec;17(12):3767-75. doi: 10.1200/JCO.1999.17.12.3767.

ReferenceCitation: Cortes JE, Kantarjian HM, O'Brien S, Giles F, Keating MJ, Freireich EJ, Estey EH. A pilot study of interleukin-2 for adult patients with acute myelogenous leukemia in first complete remission. Cancer. 1999 Apr 1;85(7):1506-13.

ReferenceCitation: Creutzig U, Ritter J, Zimmermann M, Reinhardt D, Hermann J, Berthold F, Henze G, Jurgens H, Kabisch H, Havers W, Reiter A, Kluba U, Niggli F, Gadner H. Improved treatment results in high-risk pediatric acute myeloid leukemia patients after intensification with high-dose cytarabine and mitoxantrone: results of Study Acute Myeloid Leukemia-Berlin-Frankfurt-Munster 93. J Clin Oncol. 2001 May 15;19(10):2705-13. doi: 10.1200/JCO.2001.19.10.2705.

ReferenceCitation: Foa R, Caretto P, Fierro MT, Bonferroni M, Cardona S, Guarini A, Lista P, Pegoraro L, Mandelli F, Forni G, et al. Interleukin 2 does not promote the in vitro and in vivo proliferation and growth of human acute leukaemia cells of myeloid and lymphoid origin. Br J Haematol. 1990 May;75(1):34-40. doi: 10.1111/j.1365-2141.1990.tb02613.x.

ReferenceCitation: Leblanc T, Berger R. Molecular cytogenetics of childhood acute myelogenous leukaemias. Eur J Haematol. 1997 Jul;59(1):1-13. doi: 10.1111/j.1600-0609.1997.tb00953.x.

ReferenceCitation: Maraninchi D, Blaise D, Viens P, Brandely M, Olive D, Lopez M, Sainty D, Marit G, Stoppa AM, Reiffers J, et al. High-dose recombinant interleukin-2 and acute myeloid leukemias in relapse. Blood. 1991 Nov 1;78(9):2182-7.

ReferenceCitation: Meloni G, Foa R, Vignetti M, Guarini A, Fenu S, Tosti S, Tos AG, Mandelli F. Interleukin-2 may induce prolonged remissions in advanced acute myelogenous leukemia. Blood. 1994 Oct 1;84(7):2158-63.

ReferenceCitation: Michel G, Leverger G, Leblanc T, Nelken B, Baruchel A, Landman-Parker J, Thuret I, Bergeron C, Bordigoni P, Esperou-Bourdeau H, Perel Y, Vannier JP, Schaison G. Allogeneic bone marrow transplantation vs aggressive post-remission chemotherapy for children with acute myeloid leukemia in first complete remission. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Bone Marrow Transplant. 1996 Feb;17(2):191-6.

ReferenceCitation: Michel G, Baruchel A, Tabone MD, Nelken B, Leblanc T, Thuret I, Bordigoni P, Bergeron C, Esperou-Bourdeau H, Perel Y, Vannier JP, De Lumley L, Dommergues JP, Lamagnere JP, Couillaud G, Auvrignon A, Schaison G, Leverger G. Induction chemotherapy followed by allogeneic bone marrow transplantation or aggressive consolidation chemotherapy in childhood acute myeloblastic leukemia. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Hematol Cell Ther. 1996 Apr;38(2):169-76. doi: 10.1007/s00282-996-0169-7.

ReferenceCitation: Oshimi K, Oshimi Y, Akutsu M, Takei Y, Saito H, Okada M, Mizoguchi H. Cytotoxicity of interleukin 2-activated lymphocytes for leukemia and lymphoma cells. Blood. 1986 Oct;68(4):938-48.

ReferenceCitation: Perel Y, Auvrignon A, Leblanc T, Vannier JP, Michel G, Nelken B, Gandemer V, Schmitt C, Lamagnere JP, De Lumley L, Bader-Meunier B, Couillaud G, Schaison G, Landman-Parker J, Thuret I, Dalle JH, Baruchel A, Leverger G; Group LAME of the French Society of Pediatric Hematology and Immunology. Impact of addition of maintenance therapy to intensive induction and consolidation chemotherapy for childhood acute myeloblastic leukemia: results of a prospective randomized trial, LAME 89/91. Leucamie Aique Myeloide Enfant. J Clin Oncol. 2002 Jun 15;20(12):2774-82. doi: 10.1200/JCO.2002.07.300.

ReferenceCitation: Wells RJ, Woods WG, Lampkin BC, Nesbit ME, Lee JW, Buckley JD, Versteeg C, Hammond GD. Impact of high-dose cytarabine and asparaginase intensification on childhood acute myeloid leukemia: a report from the Childrens Cancer Group. J Clin Oncol. 1993 Mar;11(3):538-45. doi: 10.1200/JCO.1993.11.3.538.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Chiron Corporation


title: Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency): Pilot Study.

acronym: Lisphem

summary: There is currently no treatment for the body symptoms of Autism Spectrum Disorders (ASD). However, basic research suggests that some forms of ASD may be alleviated, even in the adult stage. The genes involved in ASDs particularly impact synaptic homeostasis. Specific clinical trials in patients with synaptic mutations need to be carried out. In this spirit, patients with deleterious mutations in SHANK3 represent a paradigm. The induced pluripotent stem cells (iPSc) carrying SHANK3 mutations and derived in neurons, can be used for high-throughput screening of pharmacological substances and allow the identification of compounds that can restore the expression level of SHANK3. The objective of this proposed project is to test one of the compounds identified by research on these iPSc as a novel treatment for social communication deficit in patients with deleterious mutations in SHANK3. Its effect on the symptoms of the social deficit could represent a new perspective for other forms of idiopathic autism.

appel_a_projets: PHRCI

acronyme: LISPheM

titre: Effet du Lithium chez les patients ayant un Trouble du Spectre Autistique et Syndrome de Phelan-McDermid (SHANK3 haploinsuffisance) : étude pilote.

discipline_principale: autre

nom_porteur: DELORME

prenom_porteur: Richard


title: Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

summary: In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.

ReferenceCitation: Victorri-Vigneau C, Hardouin JB, Rousselet M, Gerardin M, Guerlais M, Guillou M, Bronnec M, Sebille V, Jolliet P; French Addictovigilance Network. Multicentre study for validation of the French addictovigilance network reports assessment tool. Br J Clin Pharmacol. 2016 Oct;82(4):1030-9. doi: 10.1111/bcp.13044. Epub 2016 Jul 28.

oa_colors: green other

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: Nantes University Hospital

location_facility: Centre Antipoison - Centre de Pharmacovigilance


title: Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence

acronym: Remeex

summary: We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical prostatectomy. Patient satisfaction, improvement in quality of life, side effects and complications will also be studied, as will the ease of use of the device from the point of view of the surgeon. A long-term follow-up of 5 years will be conducted.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Toulouse
Hôpital Foch
CHU de Dijon
CHU Nice
CHU Nimes
CHU de Limoges
CHU de Besançon
CHU Strasbourg
APHP Hôpital Henry Mondor
CHU Nancy


title: Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis

acronym: ENVIE

summary:
Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide burden and represent a major public health issue. In France, bronchiolitis is responsible for around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for RSV bronchiolitis are healthy full-term children.

Recent discoveries concerning the specific viral epitopes of RSV have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs).

Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV requiring medical management in healthy premature and term infants, with a favourable safety profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3, 2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European Medicines Agency (EMA) on November 4, 2022.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHU Bondy - Jean Verdier
CHI Créteil
CHU Robert-Debré
Hôpital Armand Trousseau AP-HP
CHU Toulouse-hôpital des Enfants


title: Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

acronym: PREDIC-AGE

summary:
Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
CH de SAINT-CHAMOND
CH de FEURS
CH de FIRMINY
CH de ROANNE


title: Evaluation of Preoperative Imaging (CT Scan, DOPA-PET and DOTATOC) in Patients With Small Bowel Neuroendocrine Tumors

acronym: TEGRELE

summary:
Digestive NETs are the second most common malignant digestive tumor after adenocarcinoma. The most common gastrointestinal NETs arise from the small intestine. These tumors have a high lymph node and distant metastatic potential (hepatic, pulmonary, etc.). Their management is essentially surgical and the extent of the resection essentially depends on preoperative data from conventional and isotopic imaging.

The goal of surgical resection is to remove the portion of the small intestine carrying the tumour(s) with healthy margins (so-called R0 resection) and affected lymph nodes in the mesentery (lymph node dissection). The extent of lymph node dissection, sometimes significant, exposes you to the risk of short hail with its own complications (malnutrition, diarrhoea, etc.). Consequently, an analysis of the benefits and risks between the interest of an extensive and oncological resection (R0) and the risks of short bowel must be carried out for each patient.

The reference examination to define lymph node involvement is determined by the histological examination of the resected surgical specimen (reference examination). The preoperative evaluation of lymph node extension is done by preoperative abdominal CT scan. However, the preoperative CT scan is not always consistent (sensitivity and specificity) with the pathology data (reference examination). For about 5 years, isotopic imaging (DOPA-PET and DOTATOC) has become feasible and could improve the quality of preoperative evaluation of lymph node extension. Consequently, the aim of this study is to determine the contribution of isotopic imaging (DOPA-PET and DOTATOC) in the preoperative evaluation of lymph node extension.

ReferenceCitation: Deguelte S, Hammoutene C, Poncet G, Brunaud L, Perrier M, Kianmanesh R, Cadiot G. Concept of reintervention with thorough lymphadenectomy after suboptimal resection of small-intestine neuroendocrine neoplasms: A multicentre preliminary study. J Neuroendocrinol. 2022 Jun;34(6):e13117. doi: 10.1111/jne.13117. Epub 2022 Apr 18.

ReferenceCitation: Mocellin S, Nitti D. Gastrointestinal carcinoid: epidemiological and survival evidence from a large population-based study (n = 25 531). Ann Oncol. 2013 Dec;24(12):3040-4. doi: 10.1093/annonc/mdt377. Epub 2013 Sep 19.

ReferenceCitation: Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.

ReferenceCitation: Keck KJ, Maxwell JE, Utria AF, Bellizzi AM, Dillon JS, O'Dorisio TM, Howe JR. The Distal Predilection of Small Bowel Neuroendocrine Tumors. Ann Surg Oncol. 2018 Oct;25(11):3207-3213. doi: 10.1245/s10434-018-6676-2. Epub 2018 Jul 27.

ReferenceCitation: Moertel CG. Karnofsky memorial lecture. An odyssey in the land of small tumors. J Clin Oncol. 1987 Oct;5(10):1502-22. doi: 10.1200/JCO.1987.5.10.1502. No abstract available.

lead_sponsor: Laurent BRUNAUD

location_facility: CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

intervention_type: Diagnostic Test


title: Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)

acronym: CHF-COV

summary:
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.

primary_purpose: Diagnostic

lead_sponsor: Pr. Nicolas GIRERD

intervention_type: Procedure


acronym: PRISM

lead_sponsor: Laboratoire Innotech International

summary:
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.

The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

sponsor_collaborators: International Clinical Trials Association

location_facility: TURKOVA GATOVA PERCEVAL MARICIC

title: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole

location_country: Czechia Serbia Slovakia France


title: Maintenance of Occupational Therapy for Patients With Alzheimer: A Pragmatic Randomized Trial

acronym: MaTheoAlz

summary: France put a massive effort for improving dementia care through a national Alzheimer plan in 2008 and this effort was confirmed by the next government (Neurodegenerative Diseases Plan 2014-2019). Some new care models and interventions have been implemented such as Alzheimer specialized teams offering occupational therapy. The teams intervene at home with medical prescription. A recent pilot study demonstrated that occupational therapy has the potential to bring clinical benefits for both dementia patients and their caregivers. Nevertheless, occupational therapy has been designed as a short-term intervention and the end of intervention is challenging for therapists and patients. We aim to test the clinical and economic efficacy of maintaining occupational therapy over supplementary 4 months in a pragmatic randomized controlled trial.

primary_purpose: Supportive Care

ReferenceCitation: Pimouguet C, Le Goff M, Wittwer J, Dartigues JF, Helmer C. Benefits of Occupational Therapy in Dementia Patients: Findings from a Real-World Observational Study. J Alzheimers Dis. 2017;56(2):509-517. doi: 10.3233/JAD-160820.

ReferenceCitation: Pimouguet C, Sitta R, Wittwer J, Hayes N, Petit-Moneger A, Dartigues JF, Helmer C. Maintenance of occupational therapy (OT) for dementia: protocol of a multi-center, randomized controlled and pragmatic trial. BMC Geriatr. 2019 Feb 6;19(1):35. doi: 10.1186/s12877-019-1046-x.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_concat: PubMed Central;oskar-bordeaux.fr

repositories_institution:
PubMed Central - Europe PMC
Universite de Bordeaux - Oskar-Bordeaux

lead_sponsor: University Hospital, Bordeaux

location_facility:
SSIAD Hauts de garonne
Aapam-Ssiad
Equipe Espard
Vie Santé Merignac
SESAME
AMSADHG
SSIAD du bassin d'Arcachon
Castelsanté

intervention_type: Behavioral

appel_a_projets: PREPS

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: MaTheoAlz

titre: Evaluation de l'efficacité du Maintien de la Thérapie Occupationnelle auprès des patients souffrant de maladie d'Alzheimer ou maladies apparentées : un essai contrôlé randomisé

discipline_principale: organisation des soins

nom_porteur: HELMER

prenom_porteur: Catherine


title: Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation

summary:
The term dermatoporosis (DP) was proposed by JH. Saurat in 2004 and detailed in 2007 to describe a chronic cutaneous insufficiency and fragility syndrome.

The concept of DP, the positive diagnosis and the complications are well identified in the literature. However, while the consequences of skin aging are a growing concern, knowledge of DP is stagnant.

DP is clinically defined by the combination of three clinical signs: skin atrophy, white pseudo-scars, and senile purpura. It mainly sits on photo-exposed regions: posterior face of the forearms and back of the hands in 92 to 100% of cases; but also the pre-tibial, pre-sternal, and cephalic regions.

DP appears at around 60 years old and can worsen with advancing age. Complications of varying severity can occur during its development: skin tears, delayed healing, infection, hematomas including dissecting hematomas that are sometimes life-threatening.

DP is classified into four stages defined in 2004 and revised in 2012. The autonomy of the DP entity or its integration as a marker in multi-organ failure has not yet been determined. It is a condition on the borders of several specialties requiring good coordination between them (dermatologists, general practitioners, geriatricians, nurses, etc.)

The few published epidemiological studies report a prevalence ranging from 4% to 37.5% in patients aged 50 years and over. These epidemiological data are very heterogeneous (age of recruitment, patients hospitalized or seen on an outpatient basis in consultations of different specialties, sample of the population, etc.).

Among these studies, three clinical studies, two on a French hospital cohort, the other on outpatients in Dermatology in Finland, estimated the prevalence of DP between 27 and 32% in adults aged 60 years and older. In all three studies, DP was associated with advanced age, with a risk of DP up to double in patients aged 85 and older compared to younger patients. In two of these studies, a link was suggested with the status of chronic renal failure, either independently for one, or concomitant with taking anticoagulants and corticosteroids for the other. For Kluger et al., DP was also associated with the independent use of very strong local or systemic corticosteroids. For Chanca et al., an independent link between DP and tobacco consumption, taking anticoagulant treatment, and chronic recreational sun exposure has been observed.

ReferenceCitation: Kaya G, Saurat JH. Dermatoporosis: a chronic cutaneous insufficiency/fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology. 2007;215(4):284-94. doi: 10.1159/000107621.

ReferenceCitation: Mengeaud V, Dautezac-Vieu C, Josse G, Vellas B, Schmitt AM. Prevalence of dermatoporosis in elderly French hospital in-patients: a cross-sectional study. Br J Dermatol. 2012 Feb;166(2):442-3. doi: 10.1111/j.1365-2133.2011.10534.x. Epub 2011 Dec 5. No abstract available.

ReferenceCitation: Chanca L, Fontaine J, Kerever S, Feneche Y, Forasassi C, Meaume S, Colboc H. Prevalence and risk factors of dermatoporosis in older adults in a rehabilitation hospital. J Am Geriatr Soc. 2022 Apr;70(4):1252-1256. doi: 10.1111/jgs.17618. Epub 2021 Dec 17.

ReferenceCitation: Kluger N, Impivaara S. Prevalence of and risk factors for dermatoporosis: a prospective observational study of dermatology outpatients in a Finnish tertiary care hospital. J Eur Acad Dermatol Venereol. 2019 Feb;33(2):447-450. doi: 10.1111/jdv.15240. Epub 2018 Oct 1.

lead_sponsor: University of Lorraine

collaborators: Study Director: Anne Claire Bursztejn, PHD-MD, CHU Nancy - University of Lorraine

collaborators: Study Chair: Christophe Goetz, MD, CHR Metz-Thionville - University of Lorraine

location_facility:
Mathieu Zimmermann
Jean-Louis Autissier
Mélanie Damervalle
Cabinet Varangéville
Patrick Vauthier
Cabinet Tronville en Barrois
Sophie LARUELLE
Anais Leclerc
Cédric Berbé
Stéphanie Chevalier
Sandra Pacini
Benoit Nicolas
Aurelie François
Wissam Al Shouaib
Sophie Delaporte


title: Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)

acronym: EVACO

summary: Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.

lead_sponsor: Versailles Hospital

location_facility:
Hôpital Henri Mondor
Centre Hospitalier Alpes Isère
CHU de Strasbourg
Centre Hospitalier de Versailles
Hôpital Louis Mourier
CHRU de Montpellier
Hôpital Sainte Marguerite
CHU de Clermont Ferrand


title: Redefining the Phenotypic Spectrum of Heart Failure With Preserved Ejection Fraction (HFpEF) by Deep Phenotyping and Machine Learning Methods: The PACIFIC-PRESERVED Study (PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study)

summary: This is a prospective multicenter study to decipher phenotypic variability within patients with heart failure and preserved left ventricular ejection fraction (HFpEF). From a registry of heart failure patients (2500 anticipated) hospitalized in the participating centers in the last 3 years, 300 HFpEF patients, 100 patients with heart failure and reduced ejection fraction (HFrEF) and 100 matched subjects without heart failure will be enrolled for an extensive phenotyping with physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters. Cluster analysis with machine learning methods will be performed to define phenogroups unique to the HFpEF patient population.

ReferenceCitation: Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

ReferenceCitation: De Peretti, et al. Prévalence et statut fonctionnel des cardiopathies ischémiques et de l'insuffisance cardiaque dans la population adulte en France : apports des enquêtes déclaratives " Handicap-Santé " BEH 2014; (9-10):172-81

ReferenceCitation: Galinier M, et al. Parcours de Soins. Dossier insuffisance cardiaque, encore trop d'hospitalisations pourtant évitables. État des lieux en France en 2013. Le Concours Médical 2013; 135(6):443-7

ReferenceCitation: Lindenfeld J, Albert NM, Boehmer JP et coll. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010 ; 16 (6): e1-e194. - Arnold JM, Liu P, Demers C et coll. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol 2006 ; 22 (1) : 23-45

ReferenceCitation: Blanc - SVSE 1 - Physiologie, physiopathologie, santé publique (Blanc SVSE 1) 2013

ReferenceCitation: Vasan RS, Levy D. The role of hypertension in the pathogenesis of heart failure. A clinical mechanistic overview. Arch Intern Med. 1996 Sep 9;156(16):1789-96.

ReferenceCitation: Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6.

ReferenceCitation: CDC statistics 2016; AHA Heart disease and stoke statistics 2017; European CVD statistics 2017 ; Dunlay S et al 2017 Nat Rev Cardiol

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

ReferenceCitation: Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.

ReferenceCitation: Katz DH, Beussink L, Sauer AJ, Freed BH, Burke MA, Shah SJ. Prevalence, clinical characteristics, and outcomes associated with eccentric versus concentric left ventricular hypertrophy in heart failure with preserved ejection fraction. Am J Cardiol. 2013 Oct 15;112(8):1158-64. doi: 10.1016/j.amjcard.2013.05.061. Epub 2013 Jun 28.

ReferenceCitation: Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. doi: 10.1161/CIRCULATIONAHA.106.659763. Epub 2007 Apr 2. Erratum In: Circulation. 2007 May 22;115(20):e535.

ReferenceCitation: Persson H, Lonn E, Edner M, Baruch L, Lang CC, Morton JJ, Ostergren J, McKelvie RS; Investigators of the CHARM Echocardiographic Substudy-CHARMES. Diastolic dysfunction in heart failure with preserved systolic function: need for objective evidence:results from the CHARM Echocardiographic Substudy-CHARMES. J Am Coll Cardiol. 2007 Feb 13;49(6):687-94. doi: 10.1016/j.jacc.2006.08.062. Epub 2007 Jan 26.

ReferenceCitation: Shah AM, Claggett B, Kitzman D, Biering-Sorensen T, Jensen JS, Cheng S, Matsushita K, Konety S, Folsom AR, Mosley TH, Wright JD, Heiss G, Solomon SD. Contemporary Assessment of Left Ventricular Diastolic Function in Older Adults: The Atherosclerosis Risk in Communities Study. Circulation. 2017 Jan 31;135(5):426-439. doi: 10.1161/CIRCULATIONAHA.116.024825. Epub 2016 Dec 7.

ReferenceCitation: Borbely A, van der Velden J, Papp Z, Bronzwaer JG, Edes I, Stienen GJ, Paulus WJ. Cardiomyocyte stiffness in diastolic heart failure. Circulation. 2005 Feb 15;111(6):774-81. doi: 10.1161/01.CIR.0000155257.33485.6D. Epub 2005 Feb 7.

ReferenceCitation: van Heerebeek L, Borbely A, Niessen HW, Bronzwaer JG, van der Velden J, Stienen GJ, Linke WA, Laarman GJ, Paulus WJ. Myocardial structure and function differ in systolic and diastolic heart failure. Circulation. 2006 Apr 25;113(16):1966-73. doi: 10.1161/CIRCULATIONAHA.105.587519. Epub 2006 Apr 17.

ReferenceCitation: Zile MR, Baicu CF, Ikonomidis JS, Stroud RE, Nietert PJ, Bradshaw AD, Slater R, Palmer BM, Van Buren P, Meyer M, Redfield MM, Bull DA, Granzier HL, LeWinter MM. Myocardial stiffness in patients with heart failure and a preserved ejection fraction: contributions of collagen and titin. Circulation. 2015 Apr 7;131(14):1247-59. doi: 10.1161/CIRCULATIONAHA.114.013215. Epub 2015 Jan 30.

ReferenceCitation: Adeniran I, MacIver DH, Hancox JC, Zhang H. Abnormal calcium homeostasis in heart failure with preserved ejection fraction is related to both reduced contractile function and incomplete relaxation: an electromechanically detailed biophysical modeling study. Front Physiol. 2015 Mar 20;6:78. doi: 10.3389/fphys.2015.00078. eCollection 2015.

ReferenceCitation: van Heerebeek L, Hamdani N, Falcao-Pires I, Leite-Moreira AF, Begieneman MP, Bronzwaer JG, van der Velden J, Stienen GJ, Laarman GJ, Somsen A, Verheugt FW, Niessen HW, Paulus WJ. Low myocardial protein kinase G activity in heart failure with preserved ejection fraction. Circulation. 2012 Aug 14;126(7):830-9. doi: 10.1161/CIRCULATIONAHA.111.076075. Epub 2012 Jul 17.

ReferenceCitation: Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lucke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.

ReferenceCitation: Mohammed SF, Hussain S, Mirzoyev SA, Edwards WD, Maleszewski JJ, Redfield MM. Coronary microvascular rarefaction and myocardial fibrosis in heart failure with preserved ejection fraction. Circulation. 2015 Feb 10;131(6):550-9. doi: 10.1161/CIRCULATIONAHA.114.009625. Epub 2014 Dec 31.

ReferenceCitation: Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248-61. / Weber T, Auer J, O'Rourke MF, et al. Prolonged mechanical systole and increased arterial wave reflections in diastolic dysfunction. Heart 2006;92:1616-22 / Desai AS, Mitchell GF, Fang JC, et al. Central aortic stiffness is increased in patients with heart failure and preserved ejection fraction. J Card Fail 2009;15:658-64.

ReferenceCitation: Lam CS, Roger VL, Rodeheffer RJ, Borlaug BA, Enders FT, Redfield MM. Pulmonary hypertension in heart failure with preserved ejection fraction: a community-based study. J Am Coll Cardiol. 2009 Mar 31;53(13):1119-26. doi: 10.1016/j.jacc.2008.11.051.

ReferenceCitation: Kenchaiah S, Evans JC, Levy D, et al. Obesity and the risk of heart failure. N Engl J Med 2002; 347:305-13 / Ebong IA, Goff DC Jr., Rodriguez CJ, et al. The relationship between measures of obesity and incident heart failure: the multi-ethnic study of atherosclerosis. Obesity (Silver Spring) 2013;21: 1915-22 / Sundström J, Bruze G, Ottosson J, et al. Weight loss and heart failure: a nationwide study of gastric bypass surgery versus intensive lifestyle treatment. Circulation 2017;135:1577-85.

ReferenceCitation: Lainscak M, Anker SD. Heart failure, chronic obstructive pulmonary disease, and asthma: numbers, facts, and challenges. ESC Heart Fail. 2015 Sep;2(3):103-107. doi: 10.1002/ehf2.12055. Epub 2015 Jul 31.

ReferenceCitation: Ather S, Chan W, Bozkurt B, Aguilar D, Ramasubbu K, Zachariah AA, Wehrens XH, Deswal A. Impact of noncardiac comorbidities on morbidity and mortality in a predominantly male population with heart failure and preserved versus reduced ejection fraction. J Am Coll Cardiol. 2012 Mar 13;59(11):998-1005. doi: 10.1016/j.jacc.2011.11.040.

ReferenceCitation: Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

ReferenceCitation: Villemain O, Correia M, Mousseaux E, Baranger J, Zarka S, Podetti I, Soulat G, Damy T, Hagege A, Tanter M, Pernot M, Messas E. Myocardial Stiffness Evaluation Using Noninvasive Shear Wave Imaging in Healthy and Hypertrophic Cardiomyopathic Adults. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1135-1145. doi: 10.1016/j.jcmg.2018.02.002. Epub 2018 Mar 14.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

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

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

unpaywall_oa_status: hybrid

ReferenceCitation: Raboudi A, Allanic M, Balvay D, Herve PY, Viel T, Yoganathan T, Certain A, Hilbey J, Charlet J, Durupt A, Boutinaud P, Eynard B, Tavitian B. The BMS-LM ontology for biomedical data reporting throughout the lifecycle of a research study: From data model to ontology. J Biomed Inform. 2022 Mar;127:104007. doi: 10.1016/j.jbi.2022.104007. Epub 2022 Feb 4.

license: publisher-specific-oa

license_normalized: publisher-specific

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing_description: Individual participant data used for publication could be shared through scientific collaboration with the sponsor or any collaborations implied.The sharing will respect the unital consortium agreement.

collaborators: Institut de Recherches Internationales Servier

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

collaborators: Centre National de la Recherche Scientifique, France

location_facility: AP - HP, Hôpital Européen Georges-Pompidou


title: Digital Phenotyping (Physical Activity, Sleep) in Women Over 70 Years of Age Treated for Breast Cancer With Any Type of Treatment

acronym: GrannyFit

summary: GrannyFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 200 participants over the age of 70 years treated for de novo or recurrent (local or distant) BC. Participants will receive a Withing Steel activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at 6 months and at 12 months. The investigators will evaluate clinical (e.g. comorbidities), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

lead_sponsor: Institut Curie

location_facility:
Institut GODINOT
Centre Léon Bérard
Institut Curie


title: Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients

acronym: MUCOSIM

summary: The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS


title: Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort

acronym: SAMP 2

summary: Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study

summary:
Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including:

pancreatic fistulas (PF);
surgical site infections (intra-abdominal abscess, wound infection);
delayed gastric emptying (gastroparesis);
and hemorrhage.

The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.

The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI.

Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Régional Universitaire Claude Huriez


title: Quality of Life and Cancers in Nursing Homes

acronym: QUALICE

summary:
Quality of life (QOL) of nursing homes residents with cancer in France is not known. High prevalence of neurodegenerative diseases makes it difficult. It was found that oncological management is suboptimal among Poitevin territory residents. Publications report an inadequate management of symptoms of discomfort related to cancers.

The multicentric study will comparate quality of life in patients with and without Cancers in nursing homes, including residents with neurodegenerative disease, using validated questionnaires. These questionnaires, as well as pain evaluation, will be carried out by a geriatric consultations' nurse.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Drageset J, Corbett A, Selbaek G, Husebo BS. Cancer-related pain and symptoms among nursing home residents: a systematic review. J Pain Symptom Manage. 2014 Oct;48(4):699-710.e1. doi: 10.1016/j.jpainsymman.2013.12.238. Epub 2014 Apr 3.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Novella JL, Dhaussy G, Wolak A, Morrone I, Drame M, Blanchard F, Jolly D. [Quality of life in dementia: state of the knowledge]. Geriatr Psychol Neuropsychiatr Vieil. 2012 Dec;10(4):365-72. doi: 10.1684/pnv.2012.0375. French.

ReferenceCitation: Leplege A, Perret-Guillaume C, Ecosse E, Hervy MP, Ankri J, von Steinbuchel N. [A new instrument to measure quality of life in older people: The French version of the WHOQOL-OLD]. Rev Med Interne. 2013 Feb;34(2):78-84. doi: 10.1016/j.revmed.2012.07.011. Epub 2012 Dec 23. French.

oa_host_type: closed

ReferenceCitation: Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Tilburg University - Tilburg University Research Portal

repository_institution: Aberdeen University - Aberdeen University Research Archive

repository_institution: 臺灣機構典藏 - NTUR - NTUR

publisher_dissemination: Springer

lead_sponsor: University Hospital, Caen

location_facility:
Amiens UH
Pasteur HC
Fecamp HC
Rouen UH
Saint Quentin HC
Caen UH


title: Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.

summary: In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Novartis

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Service d'Hépato-gastro-entérologie - Hôpital Saint Eloi

location_facility: Service d'Hépatologie - Hôpital Jean Minjoz

location_facility: Service de Chirurgie Générale - Hôpital Edouard Herriot

location_facility: Chirurgie Générale - Hôpital de la Conception

location_facility: Service de Chirurgie Générale - Hôpital Cochin

location_facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

location_facility: Service d'Hépato-gastro-entérologie - Hôpital de Rangueil

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Chirurgie Viscérale et Digestive - Hôpital de l'Archet

location_facility: Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez

location_facility: Service des Maladies du Foie - Hôpital Pontchaillou

location_facility: Service d'Hépatologie et Gastroentérologie - CH Henri Mondor


title: Post-surgical Scars After the Use of CACIPLIQ20: A Randomized, Double-blind, Placebo -Controlled Trial

acronym: MATRISCAR

summary:
Following surgical procedures or injury, cutaneous scars can develop due to production of collagen-rich connective tissue. These scars may be accompanied by redness, itching, pain, and restricted mobility of the skin. Typically, after a few weeks, the scar matures, becoming lighter and narrower, although full maturation of a scar may take up to 2 years. In some cases, however, cutaneous scars can be unsightly or can even become hyper- trophic or result in keloids.

Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery.

CACIPLIQ20® is a medical device used for the treatment of chronic skin ulcers, and contains a molecule belonging to the family of ReGeneraTing Agents (RGTA®). RGTA®s are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues. RGTA® accelerates tissue healing in various animal models, by stabilizing and protecting heparin-binding growth factors (HBGFs) and matrix proteins. In addition to its effects on hard-to-heal chronic wounds, CACIPLIQ20® was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies. A first open label-controlled study showed that the topical application of RGTA® improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients. Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients. The Chinese study showed that a single application of CACIPLIQ20® significantly improved scar healing quality at 14 days as well as scar symptoms including pain, swelling and exudate. The aim of the MATRISCAR study is to confirm the previous results in a double-blind, placebo-controlled randomized clinical trial.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

location_facility:
Clinique Turin
CHU Brest


title: Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation

summary: All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Neurosurgery - Henri Mondor Hospital
Clermont-Ferrand UH


title: Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

acronym: ULENAP

summary: The aim of this study is to evaluate different devices to quantify upper limb function (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30 years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new tools, and results will be compared to other testing, such as wrist, grip and pinch strength, taping, MFM measurement, and self evaluation of hand ability.

ReferenceCitation: Mercuri E, Mayhew A, Muntoni F, Messina S, Straub V, Van Ommen GJ, Voit T, Bertini E, Bushby K; TREAT-NMD Neuromuscular Network. Towards harmonisation of outcome measures for DMD and SMA within TREAT-NMD; report of three expert workshops: TREAT-NMD/ENMC workshop on outcome measures, 12th--13th May 2007, Naarden, The Netherlands; TREAT-NMD workshop on outcome measures in experimental trials for DMD, 30th June--1st July 2007, Naarden, The Netherlands; conjoint Institute of Myology TREAT-NMD meeting on physical activity monitoring in neuromuscular disorders, 11th July 2007, Paris, France. Neuromuscul Disord. 2008 Nov;18(11):894-903. doi: 10.1016/j.nmd.2008.07.003. Epub 2008 Sep 24. No abstract available.

ReferenceCitation: Seferian AM, Moraux A, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Annoussamy M, Mayer M, Maincent K, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb evaluation and one-year follow up of non-ambulant patients with spinal muscular atrophy: an observational multicenter trial. PLoS One. 2015 Apr 10;10(4):e0121799. doi: 10.1371/journal.pone.0121799. eCollection 2015.

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

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

repository_normalized: LillOA (Lille Open Archive)

repository_institution: University of Illinois at Chicago - INDIGO

evidence: oa repository (semantic scholar lookup)

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

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

publisher_dissemination: Public Library of Science

ReferenceCitation: Seferian AM, Moraux A, Annoussamy M, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Mayer M, Maincent K, Desguerre I, Themar-Noel C, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb strength and function changes during a one-year follow-up in non-ambulant patients with Duchenne Muscular Dystrophy: an observational multicenter trial. PLoS One. 2015 Feb 2;10(2):e0113999. doi: 10.1371/journal.pone.0113999. eCollection 2015.

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

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

location_facility:
Hôpital Raymond Poincare
Necker
Trousseau
Institut de Myologie


title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

acronym: on-line-HDF

summary: The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Ministry of Health, France


title: Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units

acronym: US-ADEPT

summary:
Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an analysis of blood gasses and chest imaging to determine the indication for chest physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management. Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate treatments. No study has evaluated the impact of LUS on clinical decisions in chest physiotherapy in ICU patients.

Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.

Method: The physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination, he will put forward one or several hypotheses concerning the respiratory deficiency and will confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is indicated, the physiotherapist will specify the protocol.

A lung and diaphragm US will be done following the evaluation of the clinical physiotherapist, and will make it possible to answer the question: are the results of the lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol according to the results of the US-scan.

The modification of the clinical decision will be assessed with the Net Reclassification Index (NRI).

Expected results: We expect that decisions for chest physiotherapy will be modified by LUS. The expected benefit for patients is therefore that they will be given a chest physiotherapy protocol that is better suited to the type of respiratory deficiency they are suffering from.

status: Active, not recruiting

ReferenceCitation: Xirouchaki N, Georgopoulos D. Impact of lung ultrasound on clinical decision making in critically ill patients: response to O'Connor et al. Intensive Care Med. 2014 Jul;40(7):1063. doi: 10.1007/s00134-014-3316-6. Epub 2014 May 6. No abstract available.

evidence: open (via free pdf)

ReferenceCitation: Le Neindre A, Mongodi S, Philippart F, Bouhemad B. Thoracic ultrasound: Potential new tool for physiotherapists in respiratory management. A narrative review. J Crit Care. 2016 Feb;31(1):101-9. doi: 10.1016/j.jcrc.2015.10.014. Epub 2015 Oct 26.

ReferenceCitation: Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.

ReferenceCitation: Le Neindre A, Hansell L, Wormser J, Gomes Lopes A, Diaz Lopez C, Romanet C, Choukroun G, Nguyen M, Philippart F, Guinot PG, Buscher H, Bouhemad B, Ntoumenopoulos G. Thoracic ultrasound influences physiotherapist's clinical decision-making in respiratory management of critical care patients: a multicentre cohort study. Thorax. 2023 Feb;78(2):169-175. doi: 10.1136/thoraxjnl-2021-218217. Epub 2022 Mar 23.

publisher_dissemination: British Medical Journal

ipd_sharing_description: The data that support the findings of this study will be openly available in "figshare".

lead_sponsor: Fondation Hôpital Saint-Joseph

sponsor_collaborators:
Fondation Hôpital Saint-Joseph
Hopital Forcilles
Centre Hospitalier Universitaire Dijon
St Vincent's Hospital, Sydney

location_country: Australia France

location_facility:
Hôpital Forcilles
St Vincent's Hospital
CHU de Dijon
Groupe Hospitalier Paris Saint Joseph


title: Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group

summary:
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.

Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.

Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.

The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.

ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.

ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.

In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility:
Centre de santé SABOURAUD C.E.P.C
INTERTEK