title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients

acronym: PSO-TARGET

summary:
The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.

The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.

status: Unknown status

lead_sponsor: Clinact

sponsor_collaborators:
Clinact
LEO Pharma

location_country: Belgium France

location_facility: Cliniques Universitaires Saint Luc - UCLouvain

location_facility: Hôpital d'Instruction des armées SAINTE ANNE

intervention_type: Other

status_simplified: Unknown


title: A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

acronym: NIMBLE

summary: This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Iqvia Pty Ltd

location_country:
Finland
Germany
Ireland
Poland
Australia
Japan
Canada
France
Slovenia
Portugal
Switzerland
United States
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Taiwan
Israel

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

acronym: Celestimo

summary: This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Brazil
Japan
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Ukraine
Russian Federation
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie

location_facility: Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti

location_facility: Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Hematologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Westpfalz-Klinikum GmbH; Innere Medizin 1, Hämatologie und internistischen Onkologie

location_facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

location_facility: Szpitale Pomorskie Sp. z o. o.; Oddzia? Hematologii i Transplantologii Szpiku

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Medical Center named after academician Yuri Prokopovich Spizhenko; Oncochemotherpy Department

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Medizinische Klinik IV, Hämatologie Universitätsklinikum Gießen

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Universitätsklinikum Augsburg; II. Med. Klinik

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: Cancer & Hematology Center of West Michigan

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital de Donostia; Servicio de Oncologia

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?

location_facility: Uni-Klinikum-Schleswig-Holstein; Klinik für Innere Medizin II; Hämatologie und Onkologie

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: SIResearch Centre for Radiation Medicine of AMS of Ukraine; Department of Radiation Oncohematology

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie

location_facility: Universitätsklinikum Halle; Klinik für Innere Medizin IV; Hämatologie und Onkologie

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Johns Hopkins Uni ; Sidney Kimmel Comprehensive Care Center

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie

location_facility: Sozialstiftung Bamberg - Klinikum am Bruderwald, Med. Klinik V; Hämatologie und intern. Onkologie

location_facility: Atakent Acibadem Private Hosptial Halkali Merkez Mh.,

location_facility: Baylor University Medical Center; Baylor Sammons Cancer Center

location_facility: Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: City Clinical Botkin's Hospital; City Hematological Center

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hôpital Saint-Louis; Service d'Hématologie

location_facility: Wake Forest Univ Health Svcs; Section on Hem and Onc

location_facility: Harbin Medical University Cancer Hospital

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Centre Henri Becquerel; Service Hématologie

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Universitätsklinik Rostock; Klinik für Innere Med. III, Abteilung Hämatologie/Onkologie

location_facility: Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia

location_facility: Ospedali Riuniti Umberto I; Clinica di Ematologia

location_facility: Gloucestershire Royal Hospital; Haematology Department

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique

location_facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council


title: An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study

summary: To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Association for Cancer Research

lead_sponsor: MorphoSys AG

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Austria
United States
Korea, Republic of
Spain
Taiwan
Canada
France

status_simplified: Completed


title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

summary: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

ipd_sharing: No

lead_sponsor: Mirati Therapeutics Inc.

location_country:
Germany
Ireland
Poland
Australia
Czechia
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation

location_facility:
Research SIte
Research site
Research Site


acronym: ENCORE

lead_sponsor: Insmed Incorporated

summary: The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

title: A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobact

source: euctr

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Turkey
Chile
Canada
France
Portugal
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel


title: De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade

acronym: Decrescendo

summary:
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles.

Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment.

After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1.

If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator's discretion and according to local guidelines.

Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment).

status: Suspended

design_allocation: Non-Randomized

lead_sponsor: Jules Bordet Institute

collaborators: International Drug Development Institute

location_country:
France
Australia
Switzerland
Belgium
Korea, Republic of
Israel

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Institut de Cancérologie de l'Ouest - Angers

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Seoul National University Bundang Hospital

location_facility: GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk

location_facility: Centre de Cancerologie du Grand Montpellier


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Wuhan Tongji Hospital, Tongji Medical College

location_facility: State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

location_facility: Centro De Estudio Y Prevencion Del Cancer

location_facility: Fundação Hospitalar São Francisco de Assis

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Institut Regional du Cancer de Montpellier

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Fondazione del Piemonte per I'Oncologia IRCC Candiolo

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: Centro Regional Integrado de Oncologia - CRIO

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: P.L. Shupyk National Medical Academy of Post-Graduate Education

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Shengjing Hospital of China Medical University

location_facility: Ryazan State Medical University named after I.P.Pavlov

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Universitaetsklinikum Salzburg - Landeskrankenhaus

location_facility: Indira Gandhi Institute of Medical Sciences

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Jehangir Clinical Development Center Pvt Ltd

location_facility: Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Winship Cancer Institute of Emory University

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Hospital Regional do Cancer - Hospital de Esperança

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Acharya Tulsi Regional Cancer Treatment Research Institute

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Cardiology Clinic at Montefiore Hutchinson Complex

location_facility: CEDIC Centro de Investigaciones Clinicas

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte

location_facility: Pusan National University Yangsan Hospital

location_facility: T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Chonnam National University Hwasun Hospital

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Consultorio Privado Dr Jose Arturo Rodriguez Rivera

location_facility: Sujan Surgical Cancer Hospital & Amravati Cancer Foundation

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Bangalore Medical College and Research Institute

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: State Institution Academy Of Medical Sciences Of Ukraine

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: West China Hospital of Sichuan University

location_facility: University Hospitals Seidman Cancer Center

location_facility: Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Centre hospitalier universitaire de St Etienne

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

type: Other Identifier

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
India
Belgium
China
Italy
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA

summary:
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that:

is advanced or metastatic (spread to other parts of the body);
has a certain type of abnormal gene called "BRAF"; and
has not received prior treatment.

All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day.

Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

ReferenceCitation: Schadendorf D, Dummer R, Robert C, Ribas A, Sullivan RJ, Panella T, McKean M, Santos ES, Brill K, Polli A, Pietro AD, Ascierto PA. STARBOARD: encorafenib + binimetinib + pembrolizumab for first-line metastatic/unresectable BRAF V600-mutant melanoma. Future Oncol. 2022 Jun;18(17):2041-2051. doi: 10.2217/fon-2021-1486. Epub 2022 Mar 11.

evidence: open (via page says license)

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Future Science Ltd

ReferenceCitation: Zimmer L, Livingstone E, Krackhardt A, Schultz ES, Goppner D, Assaf C, Trebing D, Stelter K, Windemuth-Kieselbach C, Ugurel S, Schadendorf D. Encorafenib, binimetinib plus pembrolizumab triplet therapy in patients with advanced BRAFV600 mutant melanoma: safety and tolerability results from the phase I IMMU-TARGET trial. Eur J Cancer. 2021 Oct 13;158:72-84. doi: 10.1016/j.ejca.2021.09.011. Online ahead of print.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Brazil
Turkey
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Municipal non-profit enterprise Khmelnytsky regional antitumor center of Khmelnytsky regional

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

location_facility: Hospital Regional Universitario de Malaga - Hospital Civil

location_facility: Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme

location_facility: Universitaetsklinikum Halle - Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

location_facility: University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

location_facility: St. Bartholomew's Hospital, Barts Health NHS Trust

location_facility: Jagiellońskie Centrum Innowacji Sp. z o .o.

location_facility: Instituto de Oncologia do Paraná - IOP Oncoville

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhya Regional Counc

location_facility: Sandton Oncology Medical Group (Pty) Ltd

location_facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovany

location_facility: ICO-Badalona Hospital Germans Trias i Pujol

location_facility: UCLA Hematology/Oncology - Westwood (Building 100)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: AdventHealth Orlando, Investigational Drug Services

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

location_facility: Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 2" of the executive body of the

location_facility: Bioclinic Thessalonikis Private Clinic Single Member S.A.

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház

location_facility: BIH of Omsk Region "Clinical Oncological Dispensary"

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center, Dept. of Pharmaceutical Services (Main O

location_facility: New Zealand Clinical Research (Christchurch)

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

location_facility: Private Medical Institution "Euromedservice"

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: CHU de Lille - Hôpital Claude Huriez Service

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Ophthalmic Consultants of Boston Inc (OCB)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Medical and diagnostic center of MedX-Ray International Group Limited Liability Company Israeli

location_facility: Advocate Medical Group-Park Ridge, Luther Lane-Oncology

location_facility: Hospital Sírio-Libanês - Unidade Bela Vista

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia, S.C Oncologia Medica

location_facility: Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

location_facility: UCHealth Sue Anschutz-Rodgers Eye Center

location_facility: McGill University Health Centre - Glen Site

location_facility: The South West Wales Cancer Institute, Swansea Bay University Health Board

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: UCLA - Hematology/Oncology - Administrative Office

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site

location_facility: University General Hospital of Heraklion

location_facility: Derzhavna ustanova Instytut zahalnoi ta nevidkladnoi khirurhii im.V.T.Zaitseva Natsionalnoi akademii

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Oncological Regional Therapeutical

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Harris Health System - Ben Taub Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: Baylor College of Medicine Medical Center

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: Azienda Sanitaria Universitaria Friuli Centrale

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o .o.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica


title: Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study

acronym: LEVO-ECMO

summary: Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service Réanimation chirurgicale cardiovasculaire-NHC

lead_sponsor_type: academique


title: Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy

summary:
In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.

After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Procedure


title: 3D Finite Element Model of Posterior Membranous Labyrinth From in Vivo MRI of Human Temporal Bone

summary: The aim of this work is to create a three-dimensional (3D) finite element model (FEM) of the human posterior membranous labyrinth, based on in vivo inner ear magnetic resonance imaging (MRI). This model has a pedagogical interest, and can serve as a basis for reflection in cases of atypical benign paroxysmal positional vertigos. It can also serve for mechanical studies of vestibular physiology.

location_facility: Service D'Orl Et de Chirurgie Cervico-Faciale


title: Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species

acronym: MIDE

summary:
Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.

The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.

primary_purpose: Prevention


title: Involuntary Memories Investigation in Schizophrenia

summary:
Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Interestingly, executive functioning has been showed impaired in schizophrenia and studies showed that their autobiographical memory impairments were directed related to their executive dysfunction.

Yet, in daily life people remember more often autobiographical memories spontaneously, without trying voluntarily to recall them.

In that case, the involuntary recall of personal past events is much less sustained by executive functioning.

In this protocol the investigators would like to investigate and compare subjective characteristics of involuntary and voluntary autobiographical memories in order to highlight the role of executive dysfunction in patients' autobiographical memory impairments.

status: Terminated

primary_purpose: Health Services Research


title: Link Between Impulsivity and Time Anticipation

summary: Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. This hypothesis questions the role of the temporal anticipation in the impulsive choices. In a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. In this case, the disorders should be observed especially when the subject anticipates a reward. Alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. To separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " Hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. The neuronal correlates will be measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.

time_perspective: Prospective


title: Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience

summary:
Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.

The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (<30 days) of support appear to improve survival in the first year after transplantation.

The haemodynamic parameters revealing this DPG are not clearly described in the literature.

hypothesis of this research is that:

DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.
Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.

location_facility: Service Réanimation chirurgicale cardio-vasculaire - NHC


title: Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies

acronym: NHYP

summary:
Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.

Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.

the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.

The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.

intervention_type: Behavioral

appel_a_projets: PHRIP

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

type_etablissement: CH

acronyme: NHYP

titre: Intérêt de l'hypnose sur la qualité de vie des patients atteints de neuropathies périphériques chroniques chimio-induites.

discipline_principale: médecine générale

nom_porteur: MAURER

prenom_porteur: Caroline


title: Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path

acronym: LuxationsHTP

summary: The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients

location_facility: Service D'Urgences Medico-Chirurgicales Adultes - Htp


summary:
The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor).

The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.

location_facility: Service de Reanimation Pediatrique Specialisee - S. Continue


summary:
The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test.

Also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.


title: Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia - A Proof of Concept Study

acronym: RETONIC

summary: Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.

status: Active, not recruiting

intervention_type: Device


title: Metabolic Study of Cockayne Syndrome

acronym: METABO-CS

summary:
Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs to the family of Nucleotide Excision Repair. It is an autosomal recessive multisystemic disorder characterized by mental retardation, microcephaly, severe growth failure with lipoatrophia, sensorial impairment, cutaneous photosensitivity, dental decay, enophtalmios. The disease is progressive causing severe impairments but there's currently no therapeutics for the disease.

Growth failure, feeding difficulties and lipoatrophia are prognostic keys of CS but physiopathology is unknown.

According to preliminary assays, our goal is to test the hypothesis that cachexia is due to hypometabolism. We also want to test the potential link between this basal metabolism modification and mitochondrial dysfunction and somatotrope axis, and correlation between the basal metabolism degree and global severity of the disease.

primary_purpose: Basic Science


title: Future Mental Projections in Schizophrenia

acronym: FutureProSchiz

summary: The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.


title: Miniinvasive Corneal Neurotization. A Pilot Study.

acronym: MICORNE

summary: Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or infection. An important and permanent visual loss of is frequently associated with the condition. NK can be congenital or acquired. Its acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction techniques of sensory neurotizations have recently been described in young patients suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve segment into a tissue to reestablish either motor or sensory innervation. The aim of the present study is to assess the outcomes of a novel sensory neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious, traumatic or iatrogenic causes will be included.


title: Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate

acronym: Ongl'HUS

summary: Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. However, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. Advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. A same study validated the technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not necessary to suture the nail bed. But, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. The aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.


title: Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception

acronym: PREMAVISION

summary:
We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception

Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life.

A secondary aim is to compare this competencies in preterm and full term control art term equivalent age.

The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants.

Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation

primary_purpose: Supportive Care


title: Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis

acronym: TYSADIFF

summary:
Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.

The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.

The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.

primary_purpose: Diagnostic

location_facility: Service de Neurologie Hôpital de Hautepierre

intervention_type: Radiation


title: Validation of a Kinetic Model of Erlotinib

summary: Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.

location_facility: Service de Pneumologie Nouvel Hôpital Civil

intervention_type: Biological


title: Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer

acronym: MBSR

summary: Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.

location_facility: Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire

intervention_type: Genetic


title: Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.

acronym: ETO VD PERIOP

summary:
The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.

Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.

location_facility: Strasbourg's New Civil Hospital, Cardiac surgical reanimation department


title: The Elderly 's Parkinsonian March : Risk Estimation Multiple Drops From an Evaluation Grid Covering the March, Executive Functions, Vision and Anxiety.

acronym: EVAMARAGEX

summary: The strong relationship between falling and severity of cognitive impairment in the elderly is well established. The association premorbid gait and executive disorders suggests that they are under tension by the same mechanisms. The gait fortiori neurological are fall risk factors. Dysfunctions underlying disorders as Parkinson called march executive disorders are subcortical origin involving so the basal ganglia. This study is indeed based on the assumption that the dysfunction of the basal ganglia as observed in parkinsonian syndromes resulting in disorders of posture and walking, by dysexecutive syndrome, anxiety and the contrast vision disorders. These gait exposed to falls and dysexecutive these disorders with cognitive impairment and greater susceptibility to confusional states. The executive disorders, gait disorders, anxiety, disturbances of vision and especially saccadic eye movements, impaired vision contrasts are well established in the degenerative parkinsonian syndromes. This study proposes a new approach to assessing gait disorders to define a high risk of falling in the presence of parkinsonian walking in the elderly over 75 years.


title: ROUTE PATIENT CONSULTANT in OUTPATIENT CARE PSYCHIATRIC EMERGENCY SERVICES AND PUBLIC OF EUROMETROPOLE STRASBOURG

acronym: PUPS

summary: Describe and analyze routes and modes of care for patients in emergency consultant in various emergency care and public psychiatric outpatient devices to provide useful information to optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and downstream of where they viewed urgently.


title: Silent Myocardial Ischemia in Patients With Diabetes Type 2: Diagnostic Value of Myocardial Strains Left Ventricular Resting Echocardiography 2D and 3D, Compared to Stress Echocardiography

summary:
The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death.

That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)


title: Anatomical and Structural Connectivity in Schizophrenias

summary:
The different subtypes of Schizophrenia might have a disordered connectivity as their final common pathways.

The investigators will use multimodal structural MRI to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects.

The coherence between structural and functional anomalies will be especially studied.

ReferenceCitation: Foucher JR, Zhang YF, Roser M, Lamy J, De Sousa PL, Weibel S, Vidailhet P, Mainberger O, Berna F. A double dissociation between two psychotic phenotypes: Periodic catatonia and cataphasia. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Aug 30;86:363-369. doi: 10.1016/j.pnpbp.2018.03.008. Epub 2018 Mar 17.

location_facility: Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study

summary:
The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial.

In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.

location_facility: Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis

acronym: CHRONOSOMNO

summary: The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.


summary: The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive inheritance, is a rare disease (70 patients described in the world). The outcome of these patients and potential complications of this disease are not, to date, yet all known and described.

location_facility: Service D'Urgences Medicales Pediatriques


title: Shulman Fasciitis Prevalence Study in Alsace

acronym: SHULMAN

summary: Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study "capture-recapture" using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.

location_facility: Service de rhumatologie, Les Hôpitaux Universitaires de Strasbourg, Centre national de référence " des maladies auto-immunes rares "


title: Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty

summary:
The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.

The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure

location_facility: CCOM, Hôpitaux Universitaires de Strasbourg


acronym: ETHNOPARK

summary: ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient acting alongside vitamin B2. It is proposed in patients with visual problems. Based on clinical and experimental data, the investigators propose a pilot open study in order to test the efficacy of "Ethnodyne visio" in patients with Parkinson 's disease (PD). The hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.

primary_purpose: Other

sponsor_collaborators:
University Hospital, Strasbourg, France
ETHNODYNE

location_facility: Service de Neurologie,Hôpital de Hautepierre

intervention_type: Dietary Supplement


title: High Frequency Jet Ventilation for Percutaneous Interventional Radiology

summary:
Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.

The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.


title: Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury: the Prospective Randomized MUSIC-TCNV Trial.

acronym: MUSIC-TCNV

summary:
Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients.

PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome.

Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well.

Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.

collaborators: Association française des traumatisés crâniens d'Alsace

collaborators: Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation

location_facility: Service d'Anesthésie Réanimation- Hôpital de Hautepierre


title: Time,Self and Spontaneous Mental Activities in Patients With Psychotic Disorders

acronym: Self and Time

summary: The main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.

collaborators: Fondation pour la Recherche Médicale (FRM)


title: Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Intermittent High Doses

acronym: AlbAlsace

summary:
Primary purpose : mortality at Day 28

Secondary purposes :

Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
Number of care-related infections within ICU


title: Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency

acronym: TSASDI

summary: The research aims at clarifying the impact of autism on personal identity in adulthood. Two studies will be made in order to compare adults with autistic spectrum disorders without intellectual deficiency and controls. In the first study (Study A), the investigators will ask subjects to tell autobiographical memories and to specify their characteristics by answering focused questions. In the second study (Study B), the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements.


acronym: PARTODYS

summary:
In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia.

The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman.

Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.


title: Randomized Controlled Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide

summary: Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent inflammatory arthritide, are non responders to the consensual 1st line of treatment : methotrexate. In these patients, it is well demonstrated that the addition of other immunomodulatory drug(s) often results in a significant improvement. However, the best option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a targeted therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate or leflunomide+salazopyrine+hydroxychloroquine could be an alternative option to targeted therapies, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of targeted therapies on triple therapy in methotrexate or leflunomide insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.

appel_a_projets: PHRCN

titre: Essai randomisé contrôlé multicentrique pragmatique comparant la triple association de traitements de fond conventionnels à l'association méthotrexate et biothérapie chez les patients ayant une polyarthrite rhumatoïde avec une réponse insuffisante au méthotrexate

discipline_principale: rhumatologie

nom_porteur: GOTTENBERG

prenom_porteur: Jacques Eric


title: Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients

acronym: HEPOIRINE

summary:
The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.

Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.

To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.

The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.

The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.

ReferenceCitation: Vienne M, Haas E, Wipf T, Grunebaum L, Levy F, Sattler L, Hoang Minh T, Severac F, Tacquard C, Collange O, Mertes PM, Steib A. Adjusted calculation model of heparin management during cardiopulmonary bypass in obese patients: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):613-620. doi: 10.1097/EJA.0000000000000784.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health


title: Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses

acronym: IPRO

summary: Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.


title: Transperineal, MRI-guided, Prostate Biopsy: First Step to Focal Treatment of Prostate Cancer

summary:
Primary purpose:

Complications and rehospitalizations after transperineal prostate biopsy MRI-guided are reduced than transrectal prostate biopsies.

Secondary purposes:

Patients tolerance after transperineal prostate biopsy MRI-guided is better than after transrectal prostate biopsies.
Core of transperineal prostate biopsies are better than core of transrectal prostate biopsies
Study of correlation between radiologic images and anatomopathologic result
Description of needle track during the procedure
Description of real time template saturation prostate biopsy
Comparison of transperineal prostate biopsy relevance according to EBM
Comparison of 1.5T MRI and 3T MRI for prostate cancer detection


acronym: POMEGA

summary: Determining whether treatment with an optimized formulation of omega 3 for 6 weeks causes a 40% decrease in the average concentration of total microparticles (MPs) in the atheromatous plaque.


title: Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case

acronym: IFE

summary:
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:

a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure


title: Clinical Effect and Cerebral Vasoconstriction Induced After Epidural Blood Patch Versus Epidural Hydroxyethyl Starch Patch in Patients With Headache Due to Intracranial Hypotension

summary: The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever, sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood patch. This alternative technique is simple to implement and does not have some of the specific blood pressure contra-indications. The study aims at comparing the "Blood Patch" group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the anesthetist, ease of implementation and effect of the injection of epidural anesthesia on cerebral blood flow within 24 hours.

location_facility: Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière


title: Autobiographical Memory Organization in Schizophrenia

acronym: AMOrSchiz

summary: The aim of the study is to investigate the temporal organization of autobiographical memory in patients with schizophrenia. Patients and control participants will be invited separately to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an automatic camera around their neck, which is called SenseCam®. Pictures obtained with SenseCam® will be later presented to the participants during the session of test. They will be asked to determine the chronological order of 12 pictures corresponding to 12 particular events of the tour. Then they will be asked to watch the complete sequence of photos from the tour and to determine the beginning and ending of the events that have occurred during the tour. According to the investigators hypotheses, patients should have difficulty to find out the correct chronological order of the photos and to determine the appropriate beginnings and endings of the events

location_facility: Service de psychiatrie 1 , Les Hôpitaux Universitaires de Strasbourg


title: Strabismus Surgery and Driving Ability

summary: The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.

time_perspective: Other

location_facility: Sevice d'ophtalmologie Les hôpitaux Universitaires de Strasbourg


title: Influence of Stress on Non Surgical Periodontal Treatment

summary: Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.


title: Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology

acronym: ECHOFUSION

summary:
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).

Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).


title: Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing

acronym: GEN-NEUROSENS

summary: Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in very rare diseases for which the previous genetic explorations remain negative to date. The aim of this project is based on groups of patients with original clinical phenotypes including neurosensory impairment without genetic cause identified to date. The investigators will study these families using whole exome sequencing to potentially identify new genes and new underlying biological pathways involved in neurosensory diseases.

location_facility: LABORATOIRE DE CYTOGENETIQUE, Hôpitaux Universitaires de Strasbourg


title: Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

summary: We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.

ReferenceCitation: Gantner P, Barnig C, Partisani M, Lee GQ, Beck-Wirth G, Faller JP, Martinot M, Mosheni-Zadeh M, Cheneau C, Batard ML, Fischer P, Fuchs A, Uring-Lambert B, Bahram S, Rey D, Fafi-Kremer S. Distribution and reduction magnitude of HIV-DNA burden in CD4+ T cell subsets depend on art initiation timing. AIDS. 2018 Apr 24;32(7):921-926. doi: 10.1097/QAD.0000000000001770.

ReferenceCitation: Gantner P, Lee GQ, Rey D, Mesplede T, Partisani M, Cheneau C, Beck-Wirth G, Faller JP, Mohseni-Zadeh M, Martinot M, Wainberg MA, Fafi-Kremer S. Dolutegravir reshapes the genetic diversity of HIV-1 reservoirs. J Antimicrob Chemother. 2018 Apr 1;73(4):1045-1053. doi: 10.1093/jac/dkx475.

evidence: open (via free pdf)

publisher_dissemination: Oxford University Press

location_facility: Hôpitaux Universitaires de Strasbourg - Trait d'Union


title: Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk

acronym: TANGO

summary: In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. The recruitment will take place during the oncogeriatric assessment consultation.

location_facility: Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre

acronyme: TANGO

titre: Suivi infirmier en onco-gériatrie : temps de répérage du risque d'épuisement de l'aidant naturel

discipline_principale: organisation des soins

nom_porteur: BOSSU

prenom_porteur: Gwenaëlle


title: Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders by Using Nextgeneration Sequencing

summary: Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by multiplex PCR combining polymorphic microsatellites familial analysis and, where possible, couple-specific mutation detection. Single-cell multiplex PCR developments are costly and time-consuming. We propose to test and clinically validate a targeted next-generation sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for probably almost every couple asking for it in our centre, without a previous couple-specific development (but only a preliminary familial analysis). It will be based on haplotyping using a large number of SNPs and mutation detection. A clinical validation will be performed by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's informed consent. Concordance of the results between PGD and reanalysis by NGS will be achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in our centre. The same technique may then be applied for other PGD indications for which a set-up is often needed.

location_facility: Laboratoire de Diagnostic préimplantatoire Site du CMCO


title: Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep

acronym: LUMI

summary:
Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.

The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.

location_facility: Unité du Sommeil - Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical

summary:
Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors, with local invasiveness and tissue destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root members). In patients where surgery is considered, negative-margin resection (R0) is recommended, but this frequently results in cosmetic/functional impairment. Moreover, prognostic impact of R0 resections remains controversial. The outcome after initial surgery depends upon several factors such as age, tumor site, and tumor size as demonstrated by recent data from the French Sarcoma Group.

Alternative therapies to DT surgery for front-line or recurrence include NSAID's, anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or radiation therapy. All of these medical approaches however may fail to achieve long-term disease control and a number of patients suffer from irreducible pain, and disability from tumor volume.

Cryoablation is a promising technique that is suitable for patients experiencing extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of the tumor, leading to cell death. The technique has many advantages, among which: the accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible with other techniques such as radiofrequency), the lack of mutilation, the possibility of repeating the procedure. The cryoablation procedure has proven to be beneficial for the treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with promising results.

In the light of these encouraging data, it is believed that patients with extra-abdominal DT not amenable to surgery unless unacceptable surgical sequel and progressing after at least two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms relief, prolonged progression-free survival and a better quality of life.

ReferenceCitation: Kurtz JE, Buy X, Deschamps F, Sauleau E, Bouhamama A, Toulmonde M, Honore C, Bertucci F, Brahmi M, Chevreau C, Duffaud F, Gantzer J, Garnon J, Blay JY, Gangi A. CRYODESMO-O1: A prospective, open phase II study of cryoablation in desmoid tumour patients progressing after medical treatment. Eur J Cancer. 2021 Jan;143:78-87. doi: 10.1016/j.ejca.2020.10.035. Epub 2020 Dec 5.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

appel_a_projets: PHRCK

acronyme: CRYODESMO 01

titre: Evaluation de la cryoablation des tumeurs desmoïdes non-abdominopelviennes inopérables évoluant sous traitement médicales

discipline_principale: oncologie, imagerie interventionnelle

nom_porteur: GANGI

prenom_porteur: Afshin


title: Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

acronym: THERMASCORT

summary:
The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.

This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).


title: Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology

summary:
Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.

The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

location_facility: esthetic, reconstruction and maxillo-facial surgery department, University Hospital


title: Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture

acronym: FLEXOR

summary:
Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.

The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)


title: Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women

acronym: IMMERSION

summary:
Like in the full immersion, studied in the context of diving, immersion in water causes a cascade of events with hemodynamic and hormonal consequences.

First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60 minutes later, hypovolemia by stimulating diuresis.

Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.

However, when the labor progresses, the dilatation bath is no longer sufficient and epidural analgesia remains the only effective method to control pain.

Used before the realization of an epidural analgesia, dilatation bath could affect blood volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked to the installation of sensory block of the epidural analgesia in the parturient (severe prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal distress).

Before beginning a study in pregnant women, it seems essential to study the hemodynamic consequences of the dilatation bath in a comparable population of volunteers healthy young women and out of the obstetrical context.

location_facility: Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre


summary:
OroDental anomalies are one of the phenotypical aspects of at least 900 rare diseases or syndromes affecting by definition less than 1 in 2000 individual within the population (almost 25 million persons in Europe).

They are often described in association with other organs or system malformations, which is understandable, because the same genes and signalling pathways regulate the oral cavity formation or odontogenesis and the development of other organs. The various dental and orofacial anomalies can be classified by type (anomalies of tooth number, shape, size, structures of mineralized tissues, eruption, resorption, tumors; anomalies of oral mucosa; anomalies of tongue…), by signalling pathways and by syndrome families.

These anomalies (for example hypodontia/oligodontia, amelogenesis imperfecta, dentinogenesis imperfecta…) become increasingly identified as diagnostic and predictive traits. Not only is it important to recognise, name appropriately and integrate these dysmorphic clues into the patient dysmorphology analysis but it is essential to synthesize the observations and confront them to existing data about similar orodental anomalies encountered in some of the corresponding mutant mouse models.

Translational approaches in development and medicine, are relevant to gain understanding of molecular events underlying clinical manifestations and to enhance diagnostic accuracy.

The aim of this study is to improve the knowledge, diagnosis and care of oral cavity pathologies encountered in rare diseases via the identification and gathering of national and international patient cohorts and to structure the molecular diagnosis behind these conditions via targeted next-generation sequencing assays. Data collection is implemented on validated accredited tools (databases) complying with the legal regulations about patient data protection and medical record collection. All information is anonymized.

New effective diagnosis and therapeutic tools are being developed.

ReferenceType: result

ReferenceCitation: Gasse B, Prasad M, Delgado S, Huckert M, Kawczynski M, Garret-Bernardin A, Lopez-Cazaux S, Bailleul-Forestier I, Maniere MC, Stoetzel C, Bloch-Zupan A, Sire JY. Evolutionary Analysis Predicts Sensitive Positions of MMP20 and Validates Newly- and Previously-Identified MMP20 Mutations Causing Amelogenesis Imperfecta. Front Physiol. 2017 Jun 14;8:398. doi: 10.3389/fphys.2017.00398. eCollection 2017.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

endpoint_id: HAL

repository_institution: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Rey T, Tarabeux J, Gerard B, Delbarre M, Le Bechec A, Stoetzel C, Prasad M, Laugel-Haushalter V, Kawczynski M, Muller J, Chelly J, Dollfus H, Maniere MC, Bloch-Zupan A. Protocol GenoDENT: Implementation of a New NGS Panel for Molecular Diagnosis of Genetic Disorders with Orodental Involvement. Methods Mol Biol. 2019;1922:407-452. doi: 10.1007/978-1-4939-9012-2_36.

publisher_dissemination: Springer-Nature

ReferenceCitation: Laugel-Haushalter V, Bar S, Schaefer E, Stoetzel C, Geoffroy V, Alembik Y, Kharouf N, Huckert M, Hamm P, Hemmerle J, Maniere MC, Friant S, Dollfus H, Bloch-Zupan A. A New SLC10A7 Homozygous Missense Mutation Responsible for a Milder Phenotype of Skeletal Dysplasia With Amelogenesis Imperfecta. Front Genet. 2019 May 28;10:504. doi: 10.3389/fgene.2019.00504. eCollection 2019.

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

ReferenceCitation: Laugel-Haushalter V, Morkmued S, Stoetzel C, Geoffroy V, Muller J, Boland A, Deleuze JF, Chennen K, Pitiphat W, Dollfus H, Niederreither K, Bloch-Zupan A, Pungchanchaikul P. Genetic Evidence Supporting the Role of the Calcium Channel, CACNA1S, in Tooth Cusp and Root Patterning. Front Physiol. 2018 Sep 26;9:1329. doi: 10.3389/fphys.2018.01329. eCollection 2018.

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

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

ReferenceCitation: Tardieu C, Jung S, Niederreither K, Prasad M, Hadj-Rabia S, Philip N, Mallet A, Consolino E, Sfeir E, Noueiri B, Chassaing N, Dollfus H, Maniere MC, Bloch-Zupan A, Clauss F. Dental and extra-oral clinical features in 41 patients with WNT10A gene mutations: A multicentric genotype-phenotype study. Clin Genet. 2017 Nov;92(5):477-486. doi: 10.1111/cge.12972. Epub 2017 Mar 19.

ReferenceCitation: Prasad MK, Laouina S, El Alloussi M, Dollfus H, Bloch-Zupan A. Amelogenesis Imperfecta: 1 Family, 2 Phenotypes, and 2 Mutated Genes. J Dent Res. 2016 Dec;95(13):1457-1463. doi: 10.1177/0022034516663200. Epub 2016 Aug 24.

ReferenceCitation: Schossig A, Bloch-Zupan A, Lussi A, Wolf NI, Raskin S, Cohen M, Giuliano F, Jurgens J, Krabichler B, Koolen DA, de Macena Sobreira NL, Maurer E, Muller-Bolla M, Penzien J, Zschocke J, Kapferer-Seebacher I. SLC13A5 is the second gene associated with Kohlschutter-Tonz syndrome. J Med Genet. 2017 Jan;54(1):54-62. doi: 10.1136/jmedgenet-2016-103988. Epub 2016 Sep 6.

ReferenceCitation: Morkmued S, Clauss F, Schuhbaur B, Fraulob V, Mathieu E, Hemmerle J, Clevers H, Koo BK, Dolle P, Bloch-Zupan A, Niederreither K. Deficiency of the SMOC2 matricellular protein impairs bone healing and produces age-dependent bone loss. Sci Rep. 2020 Sep 9;10(1):14817. doi: 10.1038/s41598-020-71749-6.

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

ReferenceCitation: Bloch-Zupan A, Huckert M, Stoetzel C, Meyer J, Geoffroy V, Razafindrakoto RW, Ralison SN, Randrianaivo JC, Ralison G, Andriamasinoro RO, Ramanampamaharana RH, Randrianazary SE, Richard B, Gorry P, Maniere MC, Rakoto Alson S, Dollfus H. Detection of a Novel DSPP Mutation by NGS in a Population Isolate in Madagascar. Front Physiol. 2016 Mar 2;7:70. doi: 10.3389/fphys.2016.00070. eCollection 2016. Erratum In: Front Physiol. 2016;7:304.

ReferenceCitation: Prasad MK, Geoffroy V, Vicaire S, Jost B, Dumas M, Le Gras S, Switala M, Gasse B, Laugel-Haushalter V, Paschaki M, Leheup B, Droz D, Dalstein A, Loing A, Grollemund B, Muller-Bolla M, Lopez-Cazaux S, Minoux M, Jung S, Obry F, Vogt V, Davideau JL, Davit-Beal T, Kaiser AS, Moog U, Richard B, Morrier JJ, Duprez JP, Odent S, Bailleul-Forestier I, Rousset MM, Merametdijan L, Toutain A, Joseph C, Giuliano F, Dahlet JC, Courval A, El Alloussi M, Laouina S, Soskin S, Guffon N, Dieux A, Doray B, Feierabend S, Ginglinger E, Fournier B, de la Dure Molla M, Alembik Y, Tardieu C, Clauss F, Berdal A, Stoetzel C, Maniere MC, Dollfus H, Bloch-Zupan A. A targeted next-generation sequencing assay for the molecular diagnosis of genetic disorders with orodental involvement. J Med Genet. 2016 Feb;53(2):98-110. doi: 10.1136/jmedgenet-2015-103302. Epub 2015 Oct 26.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories:
HAL
PubMed Central
open-archive.highwire.org
univOAK