title: DF4 Connector System Post-Approval Study

summary: The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

lead_sponsor: Medtronic

location_country:
United States
Canada
France


ReferenceType: derived

ReferenceCitation: Jankauskiene A, Drozdz D, Wasilewska A, de Paula-Bernardes R, Glazer R, Valentin M, Tan M, Chiang Y, Bapatla K. Efficacy and safety of valsartan in children aged 1-5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase. Curr Med Res Opin. 2021 Dec;37(12):2113-2122. doi: 10.1080/03007995.2021.1982681. Epub 2021 Oct 9.

name: Vilnius University, Vilnius University Hospital “Santaros klinikos”, Santariskiu 4, LT-08406 Vilnius, Lithuania

family: Jankauskiene

full_name: Augustina Jankauskiene

given: Augustina

sequence: first

name: Jagiellonian University Medical College, Department of Pediatric Nephrology and Hypertension, Krakow, Poland

family: Drozdz

full_name: Dorota Drozdz

given: Dorota

sequence: additional

name: Department of Pediatrics and Nephrology, Medical University of Białystok, Waszyngtona, Poland

family: Wasilewska

full_name: Anna Wasilewska

given: Anna

family: de Paula-Bernardes

full_name: Rejane de Paula-Bernardes

given: Rejane

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

family: Glazer

full_name: Robert Glazer

given: Robert

family: Valentin

full_name: Michele Valentin

given: Michele

family: Tan

full_name: Monique Tan

given: Monique

family: Chiang

full_name: YannTong Chiang

given: YannTong

name: Novartis Healthcare Pvt. Ltd., Hyderabad, India

family: Bapatla

full_name: Kiran Bapatla

given: Kiran

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Efficacy and safety of valsartan in children aged 1–5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

enrollment_type: Actual

primary_purpose: Treatment

location_country: Italy Brazil Guatemala France Poland Lithuania Hungary Belgium Germany

ipd_sharing: Undecided

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Open-label Titration Phase

summary: To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.

lead_sponsor_type: industriel

status_simplified: Completed


title: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

summary: The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

lead_sponsor: LEO Pharma

location_country:
France
Australia
Germany
United Kingdom
Canada

location_facility:
Central Manchester University Hosptial
Universitätsklinikum Tübingen
Centre de Recherche Dermatologique
CHU de Nantes
SKiN Centre for Dermatology
UltraNova Skincare
St John of God Dermatology
Windsor Clinical Research Inc.
Innovaderm Research Inc.
Dermadvances Research
Stratica Medical
Skin Care Centre
Durondel C.P. Inc./Dermatology Clinic


design_allocation: Non-Randomized

location_country:
Italy
United States
Sweden
Germany
France
Hungary
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

acronym: Not applicable

title: A 24-month, Multi-center, Single Arm, Prospective Study to Evaluate Renal Function, Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

summary: This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.


type: Other Identifier

title: A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms

summary: The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
United States
Sweden
Germany
France
Australia
Spain
Canada

location_facility: Indiana Blood & Marrow Transplantation (IBMT)

location_facility: University of Maryland- Biological Sciences

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

status_simplified: Ongoing


status: Terminated

lead_sponsor: Forest Laboratories

location_country:
Italy
United States
South Africa
Serbia
Ukraine
France
Poland
Hungary
Belgium
New Zealand
Spain
Estonia
Canada
Korea, Republic of
Colombia
Iceland

location_facility:
Forest Investigative Site 098
Forest Investigative Site 109
Forest Investigative Site 085
Forest Investigative Site 802
Forest Investigative Site 105
Forest Investigative Site 382
Forest Investigative Site 703
Forest Investigative Site 072
Forest Investigative Site 378
Forest Investigative Site 728
Forest Investigative Site 702
Forest Investigative Site 203
Forest Investigative Site 141
Forest Investigative Site 092
Forest Investigative Site 228
Forest Investigative Site 401
Forest Investigative Site 626
Forest Investigative Site 077
Forest Investigative Site 676
Forest Investigative Site 108
Forest Investigative Site 096
Forest Investigative Site 073
Forest Investigative Site 130
Forest Investigative Site 090
Forest Investigative Site 704
Forest Investigative Site 051
Forest Investigative Site 576
Forest Investigative Site 028
Forest Investigative Site 381
Forest Investigative Site 067
Forest Investigative Site 021
Forest Investigative Site 801
Forest Investigative Site 091
Forest Investigative Site 526
Forest Investigative Site 124
Forest Investigative Site 082
Forest Investigative Site 066
Forest Investigative Site 119
Forest Investigative Site 075
Forest Investigative Site 065
Forest Investigative Site 577
Forest Investigative Site 376
Forest Investigative Site 086
Forest Investigative Site 329
Forest Investigative Site 002
Forest Investigative Site 453
Forest Investigative Site 023
Forest Investigative Site 627
Forest Investigative Site 113
Forest Investigative Site 080
Forest Investigative Site 054
Forest Investigative Site 078
Forest Investigative Site 131
Forest Investigative Site 804
Forest Investigative Site 580
Forest Investigative Site 807
Forest Investigative Site 730
Forest Investigative Site 136
Forest Investigative Site 001
Forest Investigative Site 069
Forest Investigative Site 095
Forest Investigative Site 132
Forest Investigative Site 026
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 062
Forest Investigative Site 097
Forest Investigative Site 102
Forest Investigative Site 057
Forest Investigative Site 628
Forest Investigative Site 155
Forest Investigative Site 226
Forest Investigative Site 071
Forest Investigative Site 055
Forest Investigative Site 701
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 052
Forest Investigative Site 100
Forest Investigative Site 116
Forest Investigative Site 452
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 118
Forest Investigative Site 056
Forest Investigative Site 104
Forest Investigative Site 059
Forest Investigative Site 063
Forest Investigative Site 070
Forest Investigative Site 081
Forest Investigative Site 127
Forest Investigative Site 123
Forest Investigative Site 061
Forest Investigative Site 068
Forest Investigative Site 005
Forest Investigative Site 053
Forest Investigative Site 729
Forest Investigative Site 029
Forest Investigative Site 578
Forest Investigative Site 019
Forest Investigative Site 101
Forest Investigative Site 227
Forest Investigative Site 107
Forest Investigative Site 204
Forest Investigative Site 276
Forest Investigative Site 803

title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

summary: The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

status_simplified: Unknown


location_country:
Italy
South Africa
Serbia
Ukraine
France
Poland
Hungary
Belgium
New Zealand
Spain
Estonia
United States
Korea, Republic of
Colombia
Iceland

location_facility:
Forest Investigative Site 109
Forest Investigative Site 085
Forest Investigative Site 802
Forest Investigative Site 105
Forest Investigative Site 703
Forest Investigative Site 072
Forest Investigative Site 378
Forest Investigative Site 728
Forest Investigative Site 702
Forest Investigative Site 203
Forest Investigative Site 141
Forest Investigative Site 092
Forest Investigative Site 228
Forest Investigative Site 401
Forest Investigative Site 626
Forest Investigative Site 077
Forest Investigative Site 676
Forest Investigative Site 108
Forest Investigative Site 096
Forest Investigative Site 073
Forest Investigative Site 130
Forest Investigative Site 090
Forest Investigative Site 704
Forest Investigative Site 051
Forest Investigative Site 576
Forest Investigative Site 028
Forest Investigative Site 381
Forest Investigative Site 067
Forest Investigative Site 021
Forest Investigative Site 526
Forest Investigative Site 082
Forest Investigative Site 119
Forest Investigative Site 075
Forest Investigative Site 065
Forest Investigative Site 577
Forest Investigative Site 376
Forest Investigative Site 086
Forest Investigative Site 329
Forest Investigative Site 002
Forest Investigative Site 453
Forest Investigative Site 023
Forest Investigative Site 627
Forest Investigative Site 113
Forest Investigative Site 080
Forest Investigative Site 054
Forest Investigative Site 078
Forest Investigative Site 131
Forest Investigative Site 804
Forest Investigative Site 807
Forest Investigative Site 136
Forest Investigative Site 001
Forest Investigative Site 069
Forest Investigative Site 095
Forest Investigative Site 132
Forest Investigative Site 026
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 062
Forest Investigative Site 097
Forest Investigative Site 102
Forest Investigative Site 057
Forest Investigative Site 628
Forest Investigative Site 226
Forest Investigative Site 071
Forest Investigative Site 055
Forest Investigative Site 701
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 052
Forest Investigative Site 100
Forest Investigative Site 116
Forest Investigative Site 452
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 118
Forest Investigative Site 056
Forest Investigative Site 104
Forest Investigative Site 059
Forest Investigative Site 063
Forest Investigative Site 070
Forest Investigative Site 081
Forest Investigative Site 127
Forest Investigative Site 061
Forest Investigative Site 068
Forest Investigative Site 005
Forest Investigative Site 053
Forest Investigative Site 106
Forest Investigative Site 578
Forest Investigative Site 029
Forest Investigative Site 019
Forest Investigative Site 101
Forest Investigative Site 107
Forest Investigative Site 204
Forest Investigative Site 276

title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

summary: The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).


title:
Phase II study in patient in first line for HER - metastasis breast cancer treated with eribulin and bevacizumab

 ESSAI DE PHASE II EVALUANT L’ASSOCIATION ÉRIBULINE (HALAVEN®) + BEVACIZUMAB (AVASTIN®) CHEZ LES PATIENTES AYANT UN CANCER DU SEIN METASTATIQUE HER -

lead_sponsor: ARCAGY-GINECO


title: Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®

acronym: CogniPlus

summary: Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bayer

location_country:
Saudi Arabia
Netherlands
Kazakhstan
France
Czechia
Albania
Greece
Israel
Tunisia
Hungary
Belgium
Argentina
Algeria
Egypt
Turkey
Germany
Portugal


title: Etude de recherche sur l'élimination de la conduction dormante guidée par l'adénosine lors des procédures d'isolation des veines pulmonaires pour le traitement d'ablation par cathéter de la fibrillation auriculaire paroxystique

acronym: ADVICE

lead_sponsor: Institut de Cardiologie de Montréal

status: Ongoing


title: A Phase I/II randomized study to determine the maximum tolerated dose, safety, pharmacokinetics and antitumor activity of Debio1143 combined with concurrent Chemo-Radiation Therapy in patients with locally advanced squamous cell carcinoma of the head and neck.

lead_sponsor: Debiopharm S.A.


title: Evaluation des performances de l’échographie avec injection de produit de contraste (Sonovue®) dans la détection des métastases hépatiques synchrones ou métachrones d’un cancer colo-rectal.

acronym: SONOMETA

lead_sponsor: CHU de Caen

lead_sponsor_type: academique


title: An Open Label Multicenter Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 in Adult Subjects With Liver Dysfunction Due to Lysosomal Acid Lipase Deficiency Who Previously Received Treatment in Study LAL-CL01

summary: This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid lipase (LAL) deficiency.

ReferenceType: result

ReferenceCitation: Balwani M, Breen C, Enns GM, Deegan PB, Honzík T, Jones S, Kane JP, Malinova V, Sharma R, Stock EO, Valayannopoulos V, Wraith JE, Burg J, Eckert S, Schneider E, Quinn AG. Clinical effect and safety profile of recombinant human lysosomal acid lipase in patients with cholesteryl ester storage disease. Hepatology. 2013 Sep;58(3):950-7. doi: 10.1002/hep.26289. Epub 2013 Mar 28.

name: Department of Genetics and Genomic SciencesThe Mount Sinai School of MedicineNew YorkNY

family: Balwani

full_name: Manisha Balwani

given: Manisha

name: Manchester Academic Health Sciences CentreGenetic MedicineSt. Mary's HospitalManchesterUK

family: Breen

full_name: Catherine Breen

given: Catherine

name: Department of PediatricsLucile Packard Children's HospitalStanford UniversityStanfordCA

family: Enns

full_name: Gregory M. Enns

given: Gregory M.

name: Department of MedicineAddenbrooke's HospitalCambridgeUK

family: Deegan

full_name: Patrick B. Deegan

given: Patrick B.

name: Department of Pediatrics and Adolescent MedicineFirst Faculty of MedicineCharles University and General University HospitalPragueCzech Republic

family: Honzík

full_name: Tomas Honzík

given: Tomas

family: Jones

full_name: Simon Jones

given: Simon

name: Divisions of Endocrinology & Metabolism (JPK) and Cardiology (EOS)University of CaliforniaSan FranciscoCA

family: Kane

full_name: John P. Kane

given: John P.

family: Malinova

full_name: Vera Malinova

given: Vera

name: Salford Royal Hospital Foundation TrustSalfordUK

family: Sharma

full_name: Reena Sharma

given: Reena

family: Stock

full_name: Eveline O. Stock

given: Eveline O.

name: Inherited Metabolic DisordersHôpital Necker‐Enfants MaladesParisFrance

family: Valayannopoulos

full_name: Vassili Valayannopoulos

given: Vassili

family: Wraith

full_name: J. Edmond Wraith

given: J. Edmond

family: Burg

full_name: Jennifer Burg

given: Jennifer

family: Eckert

full_name: Stephen Eckert

given: Stephen

family: Schneider

full_name: Eugene Schneider

given: Eugene

family: Quinn

full_name: Anthony G. Quinn

given: Anthony G.

journal_name: Hepatology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Clinical effect and safety profile of recombinant human lysosomal acid lipase in patients With cholesteryl ester storage disease

ReferenceCitation: Malinová V, Balwani M, Sharma R, Arnoux JB, Kane J, Whitley CB, Marulkar S, Abel F. Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study. Liver Int. 2020 Sep;40(9):2203-2214. doi: 10.1111/liv.14603. Epub 2020 Aug 9.

name: Department for Metabolic Diseases Children's ClinicGeneral Faculty Hospital and First Faculty of Medicine of Charles University in Prague Prague Czech Republic

family: Malinová

full_name: Vĕra Malinová

given: Vĕra

name: Department of Genetics and Genomic Sciences and Department of Medicine Icahn School of Medicine at Mount Sinai New York NY USA

name: Department of Endocrinology and Metabolic Medicine Salford Royal Foundation NHS Trust Salford UK

name: Department of Inherited Metabolic Diseases Hôpital Necker‐Enfants Malades Paris France

name: Department of Medicine University of California San Francisco San Francisco CA USA

name: Advanced Therapies Program, and Gene Therapy Center University of Minnesota Minneapolis MN USA

name: Alexion Pharmaceuticals, Inc. Boston MA USA

title: Sebelipase alfa for lysosomal acid lipase deficiency: 5‐year treatment experience from a phase 2 open‐label extension study

location_country:
France
Czechia
United States
United Kingdom
Canada


title: ROPISIO - Etude de l’effet antalgique de l’infiltration périnéale de ropivacaïne 0.75% versus placebo dans la douleur périnéale post épisiotomie : étude randomisée en double aveugle.

acronym: ROPISIO

lead_sponsor: Centre Hospitalier Départemental Vendée


title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

summary: The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

location_country:
Austria
Brazil
Sweden
Germany
France
Poland
Greece
Romania
Puerto Rico
Spain
United States


title: An open label, multicenter, randomized trial of 2% chlorhexidine-70% isopropanol vs 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery

lead_sponsor: CHU DE POITIERS


title: Bénéfices de la perfusion continue de lidocaïne intraveineuse en chirurgie bariatrique : une étude randomisée prospective contre placebo

acronym: XYLOBAR

lead_sponsor: CHU CAEN


title: An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial

acronym: CONTROL

lead_sponsor: GETAID


title:
First-line treatment of Ewing tumours with primary extrapulmonary dissemination in patients from 2 to 50 years -

 Traitement de 1ère intention de patients âgés de 2 à 50 ans atteints de tumeur d’Ewing avec métastases extra-pulmonaires.

lead_sponsor: INSTITUT CURIE


title: Effects of perioperative administration of dexamethasone on postoperative complications and mortality after non-cardiac major surgery : a randomized, multicentre, double blind, study

acronym: PACMAN

lead_sponsor: CHU de Nantes


title:
Phase III, randomized, double-blind, placebo controlled, parallel-group, study of AB103 as compared to placebo in patients with necrotizing soft tissue infections (NSTI)

 Etude de phase III, randomisée, en double-aveugle, contrôlée contre placebo, en groupe parallèle, étudiant l’efficacité d’AB103 comparé au placebo chez des patients ayant des infections nécrosantes des tissus mous (NSTI)

acronym: ACCUTE

lead_sponsor: Atox Bio


title:
Impact of aminoglycosides-based antibiotics combination and protective isolation on outcomes in critically-ill neutropenic patients with sepsis:A randomized 2 by 2 factorial design randomized pragmatic trial

 Influence de la bithérapie antibiotique par aminosides et de l’isolement protecteur sur le devenir des patients neutropéniques admis en réanimation avec un sepsis :  étude randomisée double plan factoriel

lead_sponsor: Assistance Publique – Hôpitaux de Paris


title: A randomized, open-label, multicentric phase II trial of PEMBROLIZUMAB (Ketruda®) with chemotherapy versus chemotherapy alone (standard of care) as neo adjuvant treatment of ovarian cancer not amenable to front line debulking surgery.


title: Etude monocentrique, exploratoire, comparant la TEP/TDM au 68Ga-RM2 à la TEP/TDM au 68Ga-PSMA-617 chez des patients atteints de cancers de la prostate de différents risques métastatiques, candidats à une prostatectomie totale

acronym: UROPET

lead_sponsor: CHU de Bordeaux


title: Randomised Open Label Adaptive Phase III trial of addition of Belinostat to chemotherapy in patients with locally advanced potentially resectable Thymic Epithelial Tumors (TET)

acronym: BELCAP

lead_sponsor: IFCT


title:
EFFECT OF AZITHROMYCIN ON THE PROPORTION OF FAILURES OF SEVERE PERIODONTITIS NON-SURGICAL TREATMENTS : A RANDOMIZED, DOUBLE-BLIND VERSUS PLACEBO STUDY

 EFFET DE L'AZITHROMYCINE SUR LA PROPORTION D'ECHECS DES TRAITEMENTS NON-CHIRURGICAUX DES PARODONTITES SEVERES : ETUDE RANDOMISEE, EN DOUBLE AVEUGLE VERSUS PLACEBO

acronym:
AZITHROPARO

 AZITHROPARO

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title: A randomized trial of efficacy and safety of an early OUTpatient treatment of COVID-19 in patients with risk factor for poor outcome : a strategy to prevent hospitalization : OUTCOV Study

acronym: OUTCOV

lead_sponsor: GROUPE HOSPITALIER PARIS SAINT-JOSEPH


title: A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

lead_sponsor: Syros Pharmaceuticals Inc.


title:
Randomized Phase II Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab in Locally Advanced Cervical Cancer

 Etude de Phase II randomisée évaluant l’Atezolizumab, inhibiteur du ligand de mort cellulaire programmée de type 1, dans les cancers du col utérin localement évolués

acronym: AtezoLACC

lead_sponsor: Gustave Roussy


title: Treatment of bullous pemphigoid with avdoralimab (IPH5401), an anti-C5aR1 monoclonal antibody

acronym: PB

lead_sponsor: CHU NICE


title:
Étude ouverte de phase 1/2  évaluant  la sécurité et l’efficacité  de l’injection de cellules  CD34 + autologues transduites ex vivo par le vecteur lentiviral GLOBE1 qui exprime le gène de la globine βAS3  chez des patients atteints de drépanocytose.

 " A Phase 1/2 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the Sickle Cell Anemia by Transplantation of an Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced ex vivo with the GLOBE1 lentiviral vector expressing the ?AS3 globin gene (GLOBE1 ?AS3 Modified Autologous CD34+ Cells) in Patients with Sickle Cell Disease (SCD) "DREPAGLOBE

acronym: DREPAGLOBE

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: International, multicenter, randomized, double-blinded, placebo-controlled study of Recombinant Interleukin-7 (CYT107) to restore absolute lymphocyte counts (ALC) in patients with Sepsis

acronym: IRIS-7 C

lead_sponsor: RevImmune


title:
Dexamethasone associated with hydroxychloroquine vs. hydroxychloroquine alone for the early treatment of severe ARDS caused by COVID-19 : a randomized controlled trial

 Dexaméthasone associée à l'hydroxychloroquine vs. hydroxychloroquine seule dans le traitement précoce des SDRA sévères liés au COVID-19 : un essai randomisé et contrôlé

acronym: DHYSCO

lead_sponsor: Groupe Hospitalier Paris Saint-Joseph

status: Prematurely Ended


title:
Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation:
 a double-blinded randomized controlled trial

 Tocolyse en cas de rupture prématurée des membranes avant 34 semaines d’aménorrhée :
 un essai contrôlé randomisé en double-aveugle

acronym:
TOCOPROM

 TOCOPROM

lead_sponsor: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)


title: Efficacité et tolérance d'un traitement de première intention par tocilizumab dans la maladie de Takayasu: étude française multicentrique prospective. " TOCITAKA "

acronym: TOCITAKA


title:
MISOBOLD - Prostate cancer hypoxia using BOLD MRI and 18F-FMISO PET imaging

 Imagerie de l'hypoxie par IRM fonctionnelle BOLD et TEP-TDM au 18F-Misonidazole (18F-FMISO) des tumeurs de prostate à haut risque (MISOBOLD)

acronym: MISOBOLD


title: Efficacy of a selective MEK (trametinib) and BRAFV600E (dabrafenib) inhibitors associated with radioactive iodine (RAI) for the treatment of refractory metastatic differentiated thyroid cancer with RAS or BRAFV600E mutation

acronym: MERAIODE


title:
Efficacy of long-term parenteral nutrition with SmofKabiven® E concomitant to chemo- and/or immunotherapy: A prospective, randomised, controlled, open, multicentre, two-stage, adaptive clinical trial in metastatic non-small cell lung cancer

 Efficacité de la nutrition parentérale à long terme avec le SmofKabiven® E en complément d’une chimiothérapie et/ou une immunothérapie : essai clinique prospectif, randomisé, contrôlé, ouvert, multicentrique, en deux étapes, adaptatif, dans le cancer du poumon non à petites cellules métastatique

acronym: SmofKabiven® E long-term Parenteral Nutrition in Oncology

lead_sponsor: Fresenius Kabi Deutschland GmbH


title:
Multicentre, cross-over, PRAgmatic trial in Atopic Dermatitis testing long-term control effectiveness of new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation vs. placebo in a randomised, parallel-group trial

 Etude PRAgmatique, multicentrique, en cross-over, évaluant chez des sujets atteints de Dermatite Atopique, l’efficacité sur le contrôle à long terme d’un nouveau protocole de photothérapie durant l’hiver, en traitement “add-on”, avec ou sans supplémentation en vitamine D dans un essai randomisé en groupe parallèle

acronym:
PRADA

 PRADA

lead_sponsor: CHU de Rennes


title:
.

 Administration individualisée de sufentanil guidée sur la mesure de Analgesia Nociception Index (ANI) par rapport au standard de soin en chirurgie abdominale majeure : étude randomisée contrôlée de faisabilité

acronym:
.

 PHOENIX

lead_sponsor: CHU de Clermont-Ferrand


title: Double regional anesthesia in video assisted thoracoscopy

acronym: DRAVATS

lead_sponsor: CHU-Hôpitaux de Rouen


title:
Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis

 Essai prospectif, multicentrique, randomisé comparant l'infliximab au tocilizumab en termes d''efficacité et de sécurité dans la maladie de Takayasu réfractaire ou en rechute

acronym: ND

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS


title: Diurétique versus placebo dans l’embolie pulmonaire avec dilatation du ventricule droit

acronym: DIPER


title: A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy

summary: The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France
Belgium
Spain
Germany

location_facility:
Blue Ridge Cancer Care
Meritus Center For Clinical Research
Quincy Medical Group
Carolina Biooncology Institute
Marin Specialty Care, Inc.
Medical And Surgical Specialists, Llc
Montgomery Cancer Center
Local Institution

intervention_type: Biological


title:
Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: a multicenter randomized, double-blind study

 Spironolactone et fibrillation atriale survenant après chirurgie cardiaque : essai multicentrique randomisée en double aveugle

acronym:
ALDOCURE

 ALDOCURE

lead_sponsor: CHU CAEN


title:
Contraceptive Efficacy, Tolerance and Acceptability of A Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age - PHASE IV, INTERNATIONAL, OPEN-LABEL, MULTICENTRE, PROSPECTIVE STUDY

 Efficacité contraceptive, tolérance et acceptabilité d’un spermicide contenant du chlorure de benzalkonium chez les femmes de 40 ans et plus - ETUDE DE PHASE IV, INTERNATIONALE, EN OUVERT, MULTICENTRIQUE et PROSPECTIVE

acronym:
BZK40+

 BZK40+

lead_sponsor: LABORATOIRE INNOTECH INTERNATIONAL


title:
Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.

 Injections de thiosulfate de sodium dans le traitement de calcifications ou d’ossifications ectopiques. Etude pilote

acronym: ITS Pilot

lead_sponsor: CHU de LIMOGES


title:
Étude pharmacocinétique de la lidocaïne par voie intraveineuse en chirurgie bariatrique - Etude SPIRAL (Safety Profile of IntRAvenous Lidocaïne use in coelioscopic bariatric surgery)

 Étude pharmacocinétique de la lidocaïne par voie intraveineuse en chirurgie bariatrique - Etude SPIRAL (Safety Profile of IntRAvenous Lidocaïne use in coelioscopic bariatric surgery)

acronym:
SPIRAL

 SPIRAL

lead_sponsor: Hospices Civils de Lyon


title:
COTESARC - A multicentre Phase I-II study evaluating the combination of a MEK inhibitor and a PDL1 inhibitor in pediatric and adult patients with locally advanced and/or metastatic soft tissue sarcoma .

 COTESARC – Etude multicentrique, menée en ouvert, de Phase I/II visant à évaluer la combinaison d’un inhibiteur de MEK et d’un anti-PDL1 chez des patients pédiatriques et adultes présentant un sarcome des tissus mous de stade avancé ou métastatique

acronym:
COTESARC

 COTESARC

lead_sponsor: Centre Léon Bérard


title:
Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE

  TRAITEMENT DU LUPUS ERYTHEMATEUX SYSTEMIQUE REFRACTAIRE PAR INJECTION DE CELLULES SOUCHES MESENCHYMATEUSES ALLOGENIQUES ISSUES DU CORDON OMBILICAL  - MSC LES

acronym: MSC-LES


title:
LONG TERM EFFECT AND TOLERANCE OF ULIPRISTAL ACETATE IN  Charcot-Marie-TOOTH DISEASE TYPE 1A (UPACOMT)

 EFFET A LONG TERME ET TOLERANCE DE L’ACETATE D’ULIPRISTAL DANS LA MALADIE DE CHARCOT-MARIE-TOOTH DE TYPE 1A (UPACOMT)

acronym:
UPACOMT

 UPACOMT

lead_sponsor: HÔPITAUX UNIVERSITAIRES DE STRASBOURG


title: ReVAch : Test pharmacologique de réactivité vasculaire pulmonaire endothéliale dépendante à l'acétylcholine dans l'hypertension artérielle pulmonaire avec shunt cardiaque congénital de l'enfant et de l'adulte

acronym: REVACH


title:
Effectiveness of low molecular weight heparin at increased doses prophylaxis weight-adjusted, compared with lower doses prophylaxis (intermediate or standard), on the onset of venous thromboembolism in coronavirus disease 2019 (COVID-19)  hospitalized patients : The randomized multicentric controlled open-label trial COVI-DOSE

 Efficacité d’une posologie prophylactique d’héparine de bas poids moléculaire augmentée ajustée au poids, comparativement à une posologie prophylactique plus faible (intermédiaire ou standard), sur la survenue d’événements thromboemboliques veineux chez les patients atteints de COVID19 hospitalisés :  Essai multicentrique contrôlé randomisé en ouvert COVI-DOSE

lead_sponsor: CHRU de Nancy


title:
IMPROVEMENT OF LOCAL CONTROL IN SKULL BASE AND SPINE CHORDOMAS TREATED BY SURGERY AND PROTONTHERAPY TARGETING HYPOXIC CELLS REVEALED BY POSITRON EMISSION TOMOGRAPHY NITROIMIDAZOLE ([18F]FAZA) PET/CT TRACERS.

 Amélioration du contrôle local dans les chordomes de la base du crâne, du rachis mobile et du sacrum traités par chirurgie et une protonthérapie de complément ciblée sur les cellules hypoxiques mises en évidence par TEP/TDM au [18-FLUOR] Fluoroazomycine-Arabinoside ([18F]FAZA)

acronym:
PROTONCHORDE 01

 PROTONCHORDE 01

lead_sponsor: INSTITUT CURIE


title:
Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years

 Arrêt des traitements de fond à visée immunologique chez les patients de plus de 50 ans ayant une sclérose en plaques secondairement progressive

acronym: STOP-I-SEP


title:
Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease

 Étude contrôlée randomisée multicentrique sur l’intérêt des injections intra-vitréennes d’anti-VEGF comme traitement initial puis adjuvant dans la maladie de Coats

acronym:
COATS-VEGF

 COATS-VEGF

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title:
A PROSPECTIVE, MULTICENTER, OPEN-LABEL, PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF SELECTIVE INTERNAL RADIATION THERAPY PLUS XELOX, BEVACIZUMAB AND ATEZOLIZUMAB (IMMUNE CHEKPOINT INHIBITOR) IN PATIENTS WITH LIVER-DOMINANT METASTATIC COLORECTAL CANCER

 ÉTUDE DE PHASE II PROSPECTIVE, VISANT A EVALUER L’EFFICACITE ET LA TOLERANCE DE LA RADIOTHERAPIE INTERNE VECTORISEE (SIRT), ASSOCIEE AU XELOX, BEVACIZUMAB ET ATEZOLIZUMAB (INHIBITEUR DE POINT DE CONTROLE IMMUNITAIRE) CHEZ DES PATIENTS ATTEINTS D’UN CANCER COLORECTAL, AVEC METASTASES HEPATIQUES PREDOMINANTES

acronym: SIRTCI

lead_sponsor: Fédération Francophone de Cancérologie Digestive


title:
Time to transit Recovery After treatment with Naloxegol in cardiac Surgery Intensive care Trial

 Intérêt du Naloxégol dans la reprise du transit en postopératoire de chirurgie cardiaque

acronym:
TRANSIT

 TRANSIT

lead_sponsor: CMC AMBROISE PARE


title:
Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 years eligible for High Dose Therapy: a phase II study of the Intergroupe Francophone du Myélome (IFM)

  Evaluation de l’association Ixazomib, Lenalidomide, Dexamethasone en induction et consolidation longue suivie de Lenalidomide en entretien chez des patients d’âge
 ≤65 ans atteints de Myélome Multiple de novo et éligibles pour un traitement
 haute dose : une étude de phase II de l’Intergroupe Francophone du Myélome
 (IFM)

lead_sponsor: CHU de Toulouse


title:
Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study

 Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study

acronym:
BVALLO

 BVALLO


title:
HYCOVID - Hydroxychloroquine versus placebo chez les patients ayant une infection COVID-19 à risque d’aggravation secondaire : étude prospective multicentrique randomisée en double aveugle

 HYCOVID - Hydroxychloroquine versus placebo chez les patients ayant une infection COVID-19 à risque d’aggravation secondaire : étude prospective multicentrique randomisée en double aveugle

acronym:
HYCOVID

 HYCOVID

lead_sponsor: CHU Angers


title:
Transfusion savings in heart surgery: impact of individual strategy, optimized by erythropoietin (EPO) and metabolic adjustment (ScvO2)

 Epargne transfusionnelle en chirurgie cardiaque : impact d’une stratégie individualisée, optimisée par Erythropoïétine (EPO) et ajustement métabolique (ScvO2)

acronym:
BLOOCOST

 BLOOCOST

lead_sponsor: University hospital of Montpellier


title: ESTIMATION OF THE INCIDENCE OF COLONIZATION OF PERIPHERAL VENOUS CATHETERS AFTER SKIN DISINFECTION WITH 0.5% SODIUM HYPOCHLORITE, PRECEDED OR NOT BY AN APPLICATION OF 70% ETHANOL: PILOT, MONOCENTRIC, RANDOMIZED, OPEN-LABEL STUDY

acronym: DACLEAN

lead_sponsor: CHU de Poitiers


title: A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer

acronym: ENCO-BRAF

lead_sponsor: IFCT


title: Dupilumab impact on skin resident memory T cells

acronym: DupiTrem

lead_sponsor: ARCI (trade name  LYON RECHERCHE CLINIQUE : LyREC)


title:
A multicenter, open label, phase II basket trial exploring the efficacy and safety of the combination of rucaparib (PARP inhibitor) and atezolizumab (anti-PD-L1 antibody) in patients with DNA repair-deficient or platinum-sensitive solid tumors

 Etude de phase II multi-cohorte multicentrique  évaluant  l’efficacité et la sécurité d’emploi de la combinaison  rucaparib (inhibiteur de PARP) et atezolizumab (anticorps anti-PD-L1) chez des patients dont la tumeur présente un défaut de réparation de l’ADN ou est sensible aux sels de platine

acronym: ARIANES

lead_sponsor: Gustave Roussy


title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

acronym: ASPIRE

summary: The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A.

ReferenceCitation: Nolan B, Mahlangu J, Pabinger I, Young G, Konkle BA, Barnes C, Nogami K, Santagostino E, Pasi KJ, Khoo L, Winding B, Yuan H, Fruebis J, Rudin D, Oldenburg J. Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study. Haemophilia. 2020 May;26(3):494-502. doi: 10.1111/hae.13953. Epub 2020 Mar 30.

name: Children's Health Ireland at Crumlin Dublin Ireland

family: Nolan

full_name: Beatrice Nolan

given: Beatrice

name: Haemophilia Comprehensive Care Centre Faculty of Health Sciences Charlotte Maxeke Johannesburg Academic Hospital and NHLS University of Witwatersrand Johannesburg South Africa

family: Mahlangu

full_name: Johnny Mahlangu

given: Johnny

name: Medizinische Universität Wien Vienna Austria

family: Pabinger

full_name: Ingrid Pabinger

given: Ingrid

name: Children’s Hospital Los Angeles Los Angeles CA USA

family: Young

full_name: Guy Young

given: Guy

family: Konkle

full_name: Barbara A. Konkle

given: Barbara A.

name: The Royal Children’s Hospital Parkville Vic. Australia

family: Barnes

full_name: Chris Barnes

given: Chris

family: Nogami

full_name: Keiji Nogami

given: Keiji

name: Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico Milan Italy

family: Santagostino

full_name: Elena Santagostino

given: Elena

name: Royal London Haemophilia Centre Barts and The London School of Medicine and Dentistry London UK

family: Pasi

full_name: K. John Pasi

given: K. John

name: Royal Prince Alfred Hospital Camperdown NSW Australia

family: Khoo

full_name: Liane Khoo

given: Liane

family: Winding

full_name: Bent Winding

given: Bent

family: Yuan

full_name: Huixing Yuan

given: Huixing

name: Bioverativ, a Sanofi company Waltham MA USA

family: Fruebis

full_name: Joachim Fruebis

given: Joachim

family: Rudin

full_name: Dan Rudin

given: Dan

name: Institute of Experimental Haematology and Transfusion Medicine University Clinic Bonn Bonn Germany

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

journal_name: Haemophilia

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

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Nolan B, Mahlangu J, Perry D, Young G, Liesner R, Konkle B, Rangarajan S, Brown S, Hanabusa H, Pasi KJ, Pabinger I, Jackson S, Cristiano LM, Li X, Pierce GF, Allen G. Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A. Haemophilia. 2016 Jan;22(1):72-80. doi: 10.1111/hae.12766. Epub 2015 Jul 27.

name: Our Lady's Children's Hospital Dublin Ireland

name: University of the Witwatersrand Faculty of Health Sciences Johannesburg South Africa

name: Children's Hospital Los Angeles University of Southern California Keck School of Medicine Los Angeles CA USA

name: Basingstoke and North Hampshire Hospital Basingstoke UK

name: Lady Cilento Children's Hospital Brisbane Qld Australia

name: Barts and the London Comprehensive Care Center London UK

name: Medizinsche Universitat Wien Vienna Austria

title: Long‐term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A

location_country:
Australia
Belgium
India
France
Japan
Poland
Canada
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain

location_facility:
Research site
Sir Yue Kong Pao Center for Cancer
Research Site
Children Cancer Centre


title: Evaluation d’une protéine ostéo-inductrice (rhBMP-2) dans le traitement de la pseudarthrose congénitale du tibia de l’enfant

acronym: EPOPEE


title: EPOMI (ERYTHROPOIETIN IN MYOCARDIAL INFARCTION) : ESSAI RANDOMISE MULTICENTRIQUE EVALUANT L’EFFET D’UNE INJECTION D’ERYTHROPOÏETINE A LA PHASE AIGUË DE L’INFARCTUS DU MYOCARDE SUR LA TAILLE DE LA CICATRICE ET LE REMODELAGE VENTRICULAIRE GAUCHE

acronym: EPOMI

lead_sponsor: CHU Angers, directeur général, Yvonnick Morice


title: EVALUATION BIOLOGIQUE DE LA TOXICITE RENALE DU CISPLATINE ET DE L’IFOSFAMIDE (TOXIPLAT)

acronym: TOXIPLAT

lead_sponsor: Institut Claudius Regaud


title: A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease

summary: This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.

lead_sponsor: Actelion

location_country:
United States
France
Spain

location_facility: Los Angeles Biomedical Research Institute

location_facility: University of Oklahoma Health Sciences Center


title: A multicentre phase II study, estimating the efficiency and the tolerance of RAD001 (Everolimus) , in patients with endometrial metastatic cancer resistant to a first line of chemotherapy

acronym: ENDORAD

lead_sponsor: ARCAGY-GINECO


title: Comparaison de deux stratégies de sevrage de la corticothérapie chez les myasthéniques traités par Prednisone-Azathioprine

acronym: MYACOR

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Étude comparative, randomisée, double-insu, en groupes parallèles évaluant l’efficacité de l’Eductyl® versus placebo chez des patients présentant des dyschésies traitées par rééducation colo-proctologique

lead_sponsor: TECHNI-PHARMA


title: ETUDE COMPARATIVE KETAMINE DOSE UNIQUE VERSUS KETAMINE BOLUS ET PERFUSION CONTINUE DANS LA PRISE EN CHARGE DE L’ANALGESIE DES DOULEURS TRAUMATIQUES DES MEMBRES EN MEDECINE D’URGENCE PREHOSPITALIERE

acronym: KETAPERF

lead_sponsor: CHRU de Lille


title: Essai de phase II évaluant l’efficacité et la tolérance de bevacizumab associé à une chimiothérapie dans le traitement de patients atteints de tumeurs endocrines digestives bien différenciées, progressives, localement avancées/métastatiques

acronym: BETTER

lead_sponsor: Roche SAS


title: ’addition de kétoprofène à la lidocaïne en anesthésie locorégionale intraveineuse améliore-t-elle la tolérance du garrot pneumatique et l’analgésie postopératoire lors d’une chirurgie du canal carpien

acronym: ALRIV

lead_sponsor: Centre Hospitalier Universitaire de Nancy


title: Reformulated BeneFIX efficacy and safety after conversion from a pdFIX.

lead_sponsor: Wyeth Pharmaceuticals France


title: Etude prospective, randomisée, en double aveugle, comparant l'effet d'une décontamination oro-pharyngée par la povidone-iodée à un placebo sur la réduction des pneumopathies acquises sous ventilation chez les patients traumatisés crâniens graves.

acronym: SPIRIT

lead_sponsor: Centre Hospitalier Universitaire de Rennes


title: Efficacité du minoxidil chez les enfants atteints du syndrome de Williams et Beuren : un essai clinique randomisé

lead_sponsor: Hospices Civils de Lyon


title: A Long-Term Study for Extended BMN 701 Treatment of Patients With Pompe Disease Who Have Participated in a BMN 701 Study

summary: This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion every 2 weeks (qow) to patients with late-onset Pompe disease.

lead_sponsor: BioMarin Pharmaceutical

location_country:
United States
France
Australia
New Zealand
Germany
United Kingdom

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Auckland City and Starship Children's Hospital

location_facility: Univ of California San Diego School of Medicine

location_facility: University of Florida College of Medicine

location_facility: Villa Metabolica, ZKJM MC University Mainz


ReferenceCitation: Bailey DB Jr, Berry-Kravis E, Wheeler A, Raspa M, Merrien F, Ricart J, Koumaras B, Rosenkranz G, Tomlinson M, von Raison F, Apostol G. Mavoglurant in adolescents with fragile X syndrome: analysis of Clinical Global Impression-Improvement source data from a double-blind therapeutic study followed by an open-label, long-term extension study. J Neurodev Disord. 2016;8:1. doi: 10.1186/s11689-015-9134-5. Epub 2015 Dec 15.

family: Bailey

full_name: Donald B. Bailey

given: Donald B.

suffix: Jr.

family: Berry-Kravis

full_name: Elizabeth Berry-Kravis

given: Elizabeth

family: Wheeler

full_name: Anne Wheeler

given: Anne

family: Raspa

full_name: Melissa Raspa

given: Melissa

family: Merrien

full_name: Florence Merrien

given: Florence

family: Ricart

full_name: Javier Ricart

given: Javier

family: Koumaras

full_name: Barbara Koumaras

given: Barbara

family: Rosenkranz

full_name: Gerd Rosenkranz

given: Gerd

family: Tomlinson

full_name: Mark Tomlinson

given: Mark

family: von Raison

full_name: Florian von Raison

given: Florian

family: Apostol

full_name: George Apostol

given: George

currency_apc_doaj: GBP

journal_name: Journal of Neurodevelopmental Disorders

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Sweden
Switzerland
Netherlands
Germany
France
Israel
Belgium
Australia
Spain
Denmark
United States
United Kingdom

title: An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients With Fragile X Syndrome

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.


title: Essai randomisé de phase II/III évaluant une stratégie thérapeutique post-opératoire individualisée chez les patients opérés d’un carcinome bronchique non à petites cellules (CBNPC) non épidermoïde de stade II – IIIA non N2.

lead_sponsor: IFCT


title: Etude de phase II de l'association CISPLATINE TOPOTECAN et CETUXIMAB chez les patientes atteintes d'un cancer épithelial du col de l'uterus avancé ou en rechute.

acronym: ERBUS

lead_sponsor: ARCAGY


title: Programme de réhabilitation précoce dans les Néphrectomie totales pour cancer du rein

acronym: PRP

lead_sponsor: Centre hospitalier Régional et Universitaire


title: Evaluation de l’intérêt thérapeutique de MeteoSpasmyl ® administré à la demande dans la prise en charge du syndrome de l’intestin irritable.

lead_sponsor: MAYOLY-SPINDLER


title: Essai clinique comparant l'efficacité et la tolérance d'un comprimé à sucer contenant 14,63 mg d'Ibuprofène versus placebo

lead_sponsor: UNITHER Pharmaceuticals


title: Analyse prospective des pontages et valves aortiques sous anticoagulation conventionnelle versus hemi-dose en système clos et coa

acronym: APPACHES

lead_sponsor: CHU de Bordeaux


title: Evaluation de l'intérêt d'un traitement par hydroquinidine pour la prise en charge des patients atteints d'un syndrome de Brugada à risque rythmique élevé et implantés d'un défibrillateur

acronym: QUIDAM

lead_sponsor: Centre Hospitalier Universitaire de Nantes


title: ESSAI DE PHASE I DE MYOCET® CHEZ DES ENFANTS AYANT UN GLIOME MALIN REFRACTAIRE OU EN RECHUTE

acronym: MYOCET

lead_sponsor: CHU DE NANCY


title: Administration de Surfactant précoce : Evaluation chez le Nouveau-né ≥ 35 semaines d’aménorrhée présentant une détresse respiratoire

acronym: ASPEN

lead_sponsor: CHU AMIENS


title: A PLACEBO-CONTROLLED, ESCALATING DOSE, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PREGABALIN IN PEDIATRIC PATIENTS WITH PARTIAL ONSET SEIZURES

lead_sponsor: Pfizer Inc.235 East 42nd Street, New York, NY 10017


title: Essai clinique contrôlé randomisé, multicentrique, évaluant l'efficacité de deux médicaments homéopathiques (Dopamine 5 CH et Serotoninum muriaticum 5 CH) chez l'enfant TDAH âgé de 3 à 7 ans (6 ans et 11 mois).

acronym: HYP-HOPE

lead_sponsor: Laboratoires BOIRON


title: Analgésie post-opératoire après prothèse totale de hanche : Intérêt de l’infiltration péri articulaire d’anesthésiques locaux

lead_sponsor: CHU de Nîmes


title: Effet de la vaccination du grand prématuré sur les régulations cardio-respiratoires par étude en polysomnographie des variabilités

lead_sponsor: CHU de Rennes


title: An open label, multicenter trial assessing the acceptability of a new fixed dose combination of fenofibrate 80 mg bid and metformin 1000 mg bid in patients with type 2 diabetes (T2DM) and dyslipidemia.

lead_sponsor: FOURNIER Laboratories Ireland Ltd


title: Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical

lead_sponsor: CHU de Poitiers


title: Effet d’une prémédication sur la douleur, en IRM fonctionnelle, chez des volontaires sains.

lead_sponsor: CHU d'Angers


title: EXPLORATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CD5789 IN SUBJECTS WITH ACNE

lead_sponsor: GALDERMA R&D SNC


title: Essai de phase III multicentrique randomisé, comparant l’effet d’une chimiothérapie adjuvante de 6 mois par gemcitabine-oxaliplatine à 85mg/m²  (GEMOX 85) à une surveillance, chez des patients opérés d’un cancer des voies bilaires.

acronym: PRODIGE 12

lead_sponsor: FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)


title: Multicenter randomized, double blind, 3 parallel arms, controlled trial of the clinical efficacy of topical 'Diclofenac 1%, gel' (diclofenac diethylamine 1.16%) for the treatment of osteoarthritis of the knee: equivalence of Generic product versus the Reference product and superiority versus placebo.

lead_sponsor: SUBSTIPHARM DEVELOPPEMENT


title: Proof-of-concept phase II study to evaluate the anti-tumoractivity of sorafenib along with pathological and molecularchanges in tumor samples from patients with resectable hepatocellular carcinoma.

acronym: BIOSHARE

lead_sponsor: GERCOR


title: A Phase 1/2 Study of XL147 Administered in Combination with Trastuzumab or Paclitaxel and Trastuzumab in Subjects with Metastatic Breast Cancer who have Progressed on a Previous Trastuzumab- Based Regimen

lead_sponsor: Exelixis INC.


title: Cilengitide (EMD121974) in combination with irradiation in children and young adults with newly diagnosed diffuse intrinsic pontine glioma : Phase I study

lead_sponsor: Centre Oscar Lambret


title: Etude clinique randomisée du propranolol versus placebo dans le traitement des hémangiomes capillaires infantiles.

acronym: Etude Hémangiome - propanolol

lead_sponsor: CHU de Bordeaux


title: An Open-Label, Multi-Center, International Study to Investigate Drug-Drug Interactions Between AT2220 and Alglucosidase Alfa in Patients With Pompe Disease

summary: This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

lead_sponsor: Amicus Therapeutics

location_country:
United States
United Kingdom
Canada
France


title: A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)

summary: A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

ipd_sharing: No

lead_sponsor: Catalyst Pharmaceuticals, Inc.

location_country:
United States
Serbia
France
Poland
Hungary
Russian Federation
Spain
Germany


title: Étude multicentrique de phase Ib-II en escalade de dose de la trabectédine (Yondelis®) en association avec l’oxaliplatine chez des patientes atteintes d’un cancer de l’ovaire avancé prétraité.

lead_sponsor: Pharma Mar S.A.


title: Effet de différents schémas d'insulinothérapie sur la compliance artérielle, la fonction endothéliale et la fonction autonome cardiaque de patients diabétiques de type 2 mal équilibrés sous traitement antidiabétique oral : étude pilote.

acronym: INSUVASC

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


type: U.S. NIH Grant/Contract

title: Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia

acronym: DCP

summary: Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.

time_perspective: Other

ReferenceCitation: Patel N, Hanfelt J, Marsh L, Jankovic J; members of the Dystonia Coalition. Alleviating manoeuvres (sensory tricks) in cervical dystonia. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):882-4. doi: 10.1136/jnnp-2013-307316. Epub 2014 May 14.

family: Patel

full_name: N. Patel

given: N.

family: Hanfelt

full_name: J. Hanfelt

given: J.

family: Marsh

full_name: L. Marsh

given: L.

family: Jankovic

full_name: J. Jankovic

name: for the members of the Dystonia Coalition

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ipd_sharing: Yes

ipd_sharing_description: Data is available to researchers with appropriate ethics board approvals. Researchers may contact the Dystonia Coalition PI or coordinator at Emory University or the RDCRN Data Management and Coordination Center for more information.

lead_sponsor: Emory University

location_country:
Italy
United States
Germany
France
Australia
Canada
United Kingdom

location_facility: University Hospital of Schleswig-Holstein

location_facility: Houston Methodist Neurological Institute

location_facility: University College London Institute of Neurology

location_facility: University of Pennsylvania, Parkinson's Disease and Movement Disorders Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Parkinson's and Movement Disorders Institute

location_facility: Parkinson's and Movement Disorders Center of Maryland


title: Evaluation of the efficacy and safety of two methadone titration methods for the treatment of cancer-related pain with inadequate pain relief or intolerable side effects when treated with level 3 opioids.

lead_sponsor: Laboratoires Bouchara-Recordati


title: Effect of agomelatine (25 mg) given orally once a day for 7 days on cerebral activity measured by functional MRI during processing of emotional stimuli in patients with Major Depressive Disorder. A randomised, double-blind, placebo-controlled study with an open extension period of 6 months with agomelatine (25 mg).Comparison to functional MRI profiles of healthy volunteers.

lead_sponsor: Institut de Recherches Internationales Servier


title: Comparaison de deux durées (6 versus 12 semaines) de traitement antibiotique des ostéites du pied neuropathique chez le patient diabétique

lead_sponsor: Centre Hospitalier de Tourcoing


title: Intérêt de l'association du midazolam par voie sublinguale à la morphine par voie orale dans l'analgésie des fractures déplacées de l'enfant aux urgences

acronym: MIDAZODOL


title: Intérêt d’un bloc nerveux bi-tronculaire (fémoral + sciatique) prolongé associé systématiquement à l’anesthésie générale au cours du pontage fémoro-poplité : étude de l'analgésie post-opératoire et de la circulation périphérique d’aval.

acronym: BLOC-FEMPOP

lead_sponsor: CHU de clermont-Ferrand


title: Traitement néo-adjuvant des glioblastomes avec déficit neurologique inaugural marqué ou sévère par bévacizumab et témozolomide avant une radiothérapie éventuelle. Etude multicentrique de phase II.

acronym: TEMOBEVA

lead_sponsor: CHU Amiens


title: Evaluation des effets de la 9 alpha fluorohydrocortisone sur la réponse pressive à la noradrénaline, la perfusion gastrique,  le débit huméral  et la rigidité artérielle dans le choc septique.

acronym: FLUDRO

lead_sponsor: C.H.U. de RENNES


title: Amikacine nébulisée à forte dose. Pharmacocinétique dans la pneumonie associée à la ventilation mécanique D’ARTAGNAN 3

lead_sponsor: Association pour la promotion de la réanimation médicale à Tours


title: Effects of ivabradine IV versus placebo on haemodynamic parameters in patients with a low cardiac output syndrome following planned coronary artery bypass surgery and requiring positive inotropic treatment. A phase II, single blind, exploratory, multicentre study.


title:
Phase 2 multicenter study to assess the safety and efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy.

 Etude multicentrique de phase 2 évaluant la tolérance et l’efficacité du BKM120 en monothérapie dans le cancer de l’endomètre métastatique d’emblée ou en rechute après une première ligne, chez des patientes ne pouvant être traitées avec une chirurgie locale et/ou une radiothérapie.

acronym: ENDOPIK

lead_sponsor: ARCAGY


title: Effets du traitement substitutif par hormone de croissance chez les patients présentant un déficit somatotrope sévère secondaire à un traumatisme crânien


title: Rôle de la dopamine dans le comportement d’aversion à la perte : étude chez le patient parkinsonien

acronym: Aversion à la perte MPI

lead_sponsor: CHU Clermont-Ferrand


title: Essai clinique comparatif chez l'adulte de DYNEXANgival 1%, crème buccale, contre placebo, dans le traitement des douleurs aiguës de la muqueuse buccale.

lead_sponsor: Laboratoire Kreussler Pharma


title:
ISOTOVE study
 Isotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origin

 Etude ISOTOVE
 Etude isotopique de la distribution intrapéritonéale d’une chimiothérapie loco-régionale post-opératoire pour carcinose péritonéale d’origine ovarienne

lead_sponsor: Centre Jean Perrin


title:
/

 Etude prospective de l’influence des faisceaux inhibiteurs descendants de la douleur sur l’efficacité du milnacipran utilisé pour la fibromyalgie.

acronym: FibroFD

lead_sponsor: CHU de Clermont-Ferrand


title: Evaluation méthodologique de la tomographie par émission de positons couplée au scanner (TEP-TDM) au Fluoromisonidazole marqué au fluor 18 ([18F]-FMISO) dans l’évaluation de la réponse au traitement des glioblastomes non opérés

acronym: MISOGLIO

lead_sponsor: CHU de Bordeaux


title:
Multicentre trial evaluating the immunogenicity of HPV vaccination in girls on immunosuppressive therapy.

 Essai clinique multicentrique évaluant la réponse immunologique de la vaccination contre  l’infection par les papillomavirus humains (HPV) 6, 11, 16, 18 chez des jeunes filles recevant un traitement immunosuppresseur

acronym:
PRIMAVERA

 PRIMAVERA


title: Phase III, multicentre, double-blind, randomised, placebo-controlled, study to assess the efficacy of V0337 SO 01A suspension 10ml 4 times a day during 7 days on 2 parallel groups of patients suffering from symptoms of gastro-oesophageal reflux disease (GORD)

lead_sponsor: PIERRE FABRE MEDICAMENT


title: ONCOMEO : Etude pilote évaluant la réponse tumorale chez des patients en échappement thérapeutique et traités par Ruta graveolens 9 CH ou Phenacetinum 4 CH

acronym: ONCOMEO

lead_sponsor: BOIRON


title: A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype

summary: This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.

time_perspective: Retrospective

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
France
United States
United Kingdom
Canada

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: North Shore Long Island Jewish Medical Center

location_facility: Instituto Giannina Gaslini- Ospedale Pediatrico IRCCS


title:
A prospective phase II trial of cabazitaxel in male patients with chemotherapy pre-treated metastatic non-seminomatous germ-cell tumors

 Etude de phase II prospective évaluant le cabazitaxel chez des hommes atteints de tumeurs germinales non séminomateuses avancées pré traités par chimiothérapie

acronym: CABA GCT

lead_sponsor: Gustave Roussy


title: A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT

acronym: MEMMAT

summary: Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined.

status: Recruiting

lead_sponsor: Medical University of Vienna

location_country:
Austria
Sweden
France
Czechia
Norway
Spain
Denmark
United States

location_facility: Dana-Farber Cancer Institute and Boston Children's Hospital

location_facility: Dell Children's Medical Group SFC-HEM/ONC

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus

location_facility: Kepler Universitätsklinikum Med Campus IV


title:
Tau brain imaging in typical and atypical Alzheimer’s Disease (AD)

 Imagerie de la protéine Tau dans les formes typiques et atypiques de la maladie d’Alzheimer (MA).

acronym:
TEPTAU

 TEPTAU

lead_sponsor: CHRU DE TOURS


title: Phase II study evaluating the benefit of sequential treatment with Gemcitabine/Nab-Paclitaxel (Gembrax) then Folfirinox followed by adaptative MRI-guided stereotactic radiotherapy in patients with locally advanced adenocarcinoma of the pancreas

acronym: GABRINOX-ART

lead_sponsor: Institut régional du cancer de Montpellier (ICM)


title:
Transmucosal Effentora® efficacy and safety for pre-emptive procedural pain treatment in opioid tolerant cancer patients.

 Évaluation de l’efficacité antalgique et de la tolérance d’Effentora® par voie transmuqueuse dans la prévention des procédures douloureuses chez les patients cancéreux traités par opioïdes

acronym:
EPP

 EPP

lead_sponsor: Association Bigorre Douleurs


title: A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies

summary: The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

ReferenceType: background

ReferenceCitation: Thijssen R, Ter Burg J, Garrick B, van Bochove GG, Brown JR, Fernandes SM, Rodríguez MS, Michot JM, Hallek M, Eichhorst B, Reinhardt HC, Bendell J, Derks IA, van Kampen RJ, Hege K, Kersten MJ, Trowe T, Filvaroff EH, Eldering E, Kater AP. Dual TORK/DNA-PK inhibition blocks critical signaling pathways in chronic lymphocytic leukemia. Blood. 2016 Jul 28;128(4):574-83. doi: 10.1182/blood-2016-02-700328. Epub 2016 May 27.

ReferenceCitation: Munster P, Mita M, Mahipal A, Nemunaitis J, Massard C, Mikkelsen T, Cruz C, Paz-Ares L, Hidalgo M, Rathkopf D, Blumenschein G Jr, Smith DC, Eichhorst B, Cloughesy T, Filvaroff EH, Li S, Raymon H, de Haan H, Hege K, Bendell JC. First-In-Human Phase I Study Of A Dual mTOR Kinase And DNA-PK Inhibitor (CC-115) In Advanced Malignancy. Cancer Manag Res. 2019 Dec 13;11:10463-10476. doi: 10.2147/CMAR.S208720. eCollection 2019.

family: Munster

full_name: Pamela Munster

given: Pamela

family: Mita

full_name: Monica Mita

given: Monica

family: Mahipal

full_name: Amit Mahipal

given: Amit

family: Nemunaitis

full_name: John Nemunaitis

given: John

family: Massard

full_name: Christophe Massard

given: Christophe

family: Mikkelsen

full_name: Tom Mikkelsen

given: Tom

family: Cruz

full_name: Cristina Cruz

given: Cristina

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Hidalgo

full_name: Manuel Hidalgo

given: Manuel

family: Rathkopf

full_name: Dana Rathkopf

given: Dana

family: Blumenschein Jr

full_name: George Blumenschein Jr

family: Smith

full_name: David C Smith

given: David C

family: Eichhorst

full_name: Barbara Eichhorst

family: Cloughesy

full_name: Tim Cloughesy

given: Tim

family: Filvaroff

full_name: Ellen H Filvaroff

given: Ellen H

family: Li

full_name: Shaoyi Li

given: Shaoyi

family: Raymon

full_name: Heather Raymon

given: Heather

family: de Haan

full_name: Hans de Haan

given: Hans

family: Hege

full_name: Kristen Hege

given: Kristen

family: Bendell

full_name: Johanna C Bendell

given: Johanna C

currency_apc_doaj: USD

journal_name: Cancer Management and Research

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

location_facility: Henry Ford Medical Center - New Center One

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute


title: Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe: Predicting Postoperative Pulmonary Complications in Europe: a 7-day Data Collection, Prospective, Observational Study

acronym: PERISCOPE

summary: Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.

ReferenceCitation: Canet J, Hardman J, Sabaté S, Langeron O, Abreu MG, Gallart L, Belda J, Markstaller K, Pelosi P, Mazo V. PERISCOPE study: predicting post-operative pulmonary complications in Europe. Eur J Anaesthesiol. 2011 Jun;28(6):459-61. doi: 10.1097/EJA.0b013e328344be2d.

ReferenceCitation: Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

ReferenceCitation: Russotto V, Sabaté S, Canet J; PERISCOPE group; of the European Society of Anaesthesiology (ESA) Clinical Trial Network. Development of a prediction model for postoperative pneumonia: A multicentre prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):93-104. doi: 10.1097/EJA.0000000000000921.

family: Russotto

full_name: Vincenzo Russotto

given: Vincenzo

family: Sabaté

full_name: Sergi Sabaté

given: Sergi

family: Canet

full_name: Jaume Canet

given: Jaume

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Canet J, Sabaté S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.

family: Mazo

full_name: Valentín Mazo

given: Valentín

family: Gallart

full_name: Lluís Gallart

given: Lluís

family: de Abreu

full_name: Marcelo Gama de Abreu

given: Marcelo Gama

family: Belda

full_name: Javier Belda

given: Javier

family: Langeron

full_name: Olivier Langeron

given: Olivier

family: Hoeft

full_name: Andreas Hoeft

given: Andreas

family: Pelosi

full_name: Paolo Pelosi

given: Paolo

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

lead_sponsor: European Society of Anaesthesiology

location_country:
Luxembourg
Romania
Belgium
Russian Federation
Czech Republic
Ukraine
Croatia
France
Lithuania
Poland
Turkey
Switzerland
Hungary
Portugal
Germany
Italy
Bosnia and Herzegovina
Albania
Spain
Estonia
Latvia

location_facility: Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione

location_facility: ZithaKlinik, Anaesthesiology and Intensive Care

location_facility: University Hospital centre "Mother Theresa" Anesthesia & critical Care

location_facility: University Hospital Bonn, Anesthesiology

location_facility: Clinica Universidad de Navarra, Anaesthesia

location_facility: Azienda Ospedaliera S. Croce e Carle, Anesthesia

location_facility: Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine

location_facility: Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care

location_facility: Hospital Universitari Germans Trias i Pujol, Anaesthesiology

location_facility: Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care

location_facility: Virgen del Rocio General Universitary Hospital;Anaesthesiology

location_facility: Tartu University Hospital Clinic of Anaesthesiology and Intensive Care

location_facility: Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin

location_facility: Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology

location_facility: Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care

location_facility: General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care

location_facility: Krasnoyarsk State Medical University,Anesthesiology and Intensive Care

location_facility: Hospital Universitario de Móstoles, anestesiología y Reanimación

location_facility: Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit

location_facility: European Institute of Oncology,Anaesthesia and Intensive Care

location_facility: Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care

location_facility: Hospital General de La Palma, Anestesiología y Reanimación

location_facility: Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology

location_facility: Hospital de Denia,Anesthesia and Intensive Care

location_facility: Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology

location_facility: Hospital Santa Maria, Departement of Anesthesiology

location_facility: Hospital Clínic Universitari de València, Anestesiología y Reanimación

location_facility: University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy

location_facility: Vall d'Hebron University Hospital, Anaesthesiology

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine

location_facility: Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology

location_facility: Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

location_facility: Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment

location_facility: P Stradins Clinical University hospital, Departement of Anesthesiology

location_facility: Hospital General Universitario Alicante, Anaesthesiology

location_facility: University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care

location_facility: Hospital Arnau de Vilanova Departement of Anesthesiology

location_facility: Hospital Universitario de La Princesa, Anesthesiology

location_facility: Medical Faculty of Istanbul, Istanbul University, Anaesthesiology

location_facility: Corporació Sanitària Parc Taulí, Anaesthesiology

location_facility: St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment

location_facility: Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia

location_facility: Instituto Português de Oncologia, Departement of Anesthesiology

location_facility: Universitätsmedizin Mainz, Departement of Anesthesiology

location_facility: Hospital del Tajo Anaesthesia and Reanimation

location_facility: University Hospital Rijeka Anaesthesiology and Intensive care

location_facility: MISEK Kft., Anaesthesiology and Intensive Care Unit


title: Essai randomisé versus placebo, en double aveugle, de l'efficacité d'un anticorps humanisé dirigé contre le récepteur soluble de l'IL6 (tocilizumab) chez des patients souffrant d'une arthrose digitale invalidante et réfractaire aux traitements usuels

acronym: TIDOA

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Efficacy and feasibility of pasireotide to reduce clinically relevant digestive leakage after complete cytoreductive surgery (CRS) plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis – a phase II randomized multicentric trial

 Evaluation de la faisabilité et de l’efficacité d’un traitement par pasireotide dans la réduction du taux de fistules digestives sévères après chirurgie de cytoréduction complète suivie de  chimio-hyperthermie intra-péritonéale pour carcinose péritonéale – Essai de phase 2 randomisé multicentrique.

acronym: PASIREOCHIP


title:
A PHASE II PROSPECTIVE STUDY “GFM-DACORAL-DLI”
 ASTX727 AND DONOR LYMPHOCYTE INFUSIONS (DLI) AFTER ALLOGENEIC STEM CELL TRANSPLANTATION (ALLO SCT) IN VERY HIGH RISK MDS OR AML PATIENTS

 Étude prospective de phase II évaluant l’ASTX727 et les injections des lymphocytes du donneur (DLI) chez les patients atteints de syndrome myélodysplasique de très haut risque ou de leucémie aiguë myéloblastique

acronym:
ASTX727 after allogenic stem cell transplantation

 ASTX727 en traitement de maintenance après greffe de moelle osseuse

lead_sponsor: Groupe Francophone des Myélodysplasies (GFM)


title:
Development of a tool for adapting dosage of fluoroquinolones by using a population pharmacokinetic model

 Elaboration d’un outil d’aide à l’adaptation de posologie de fluoroquinolones par l’utilisation d’un modèle de pharmacocinétique de population

lead_sponsor: CHU de Rennes


title:
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis.

 Étude ouverte, multicentrique, de phase 3 pour évaluer l’efficacité de l’association à dose fixe Elbasvir/Grazoprevir pendant 8 semaines, chez des patients naïfs de traitements antiviraux et présentant une infection chronique au virus de l’hépatite C de génotype 1b avec un taux de fibrose hépatique faible

acronym:
MK2

 MK2


title:
FAISABILITE DE LA PROTHESE TOTALE DU GENOU EN AMBULATOIRE : APPORT DU BLOC SCIATIQUE

 FAISABILITE DE LA PROTHESE TOTALE DU GENOU EN AMBULATOIRE : APPORT DU BLOC SCIATIQUE

lead_sponsor: Association AERCOT


title:
Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial. BETADOSE

 Réduction de la dose anténatale de bétamethasone administrée pour prévenir les complications néonatales de la grande prématurité:Essai randomisé multicentrique en double aveugle contre placebo de non infériorité. BETADOSE

acronym: BETADOSE


title:
Immunotherapy in neoadjuvant and adjuvant setting in patients with advanced HCC treated by electroporation in curative intent: French multicenter phase 2 therapeutic trial

 Immunothérapie en traitement néoadjuvant et adjuvant chez les patients atteints de CHC avancé traités par électroporation en intention curative: Etude française, prospective multicentrique de phase 2.

acronym: NIVOLEP


title:
Radiotherapy of multiple brain metastases using AGuIX® gadolinium-chelated polysiloxane based nanoparticles: a prospective randomized phase II clinical trial.

 Traitement de métastases cérébrales multiples par Radiothérapie et nanoparticule de gadolinium, AGuiX® : étude prospective randomisée de phase II.

lead_sponsor: Grenoble Alps University Hospital


title:
Mesure de la clairance plasmatique du iohexol chez les patients sortant de réanimation après insuffisance rénale aiguë

 Mesure de la clairance plasmatique du iohexol chez les patients sortant de réanimation après insuffisance rénale aiguë

acronym:
IOXSOR

 IOXSOR

lead_sponsor: CHU Angers


title:
FLEGME (FLuoresceine dans l’Exérèse des GlioMEs) : Intérêt de la fluorescéine dans la résection fluoroguidée des glioblastomes : une étude randomisée

 FLEGME (FLuoresceine dans l’Exérèse des GlioMEs) : Intérêt de la fluorescéine dans la résection fluoroguidée des glioblastomes : une étude randomisée

acronym:
FLEGME

 FLEGME

lead_sponsor: Centre Hospitalier Universitaire de Rennes


title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Safety and Efficacy of LX3305, a Sphingosine-1-Phosphate Lyase Inhibitor, for Treatment of Darier’s Disease or Hailey-Hailey Disease

lead_sponsor: Dermecular Therapeutics, Inc.


title:
Braking effect on myopia with atropine eye drops at 0.01%.

 Effet freinateur sur la myopie par l’atropine collyre à 0.01%

acronym:
Myopia stop

 Myopie stop

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title:
A one-year, single-arm, open-label, multicenter study assessing the effect of brolucizumab on disease control in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration (SWIFT)

 Etude multicentrique, en ouvert, sur un an, avec un bras de traitement, évaluant l’efficacité anatomique de brolucizumab sur le contrôle de la maladie chez des patients atteints de dégénérescence maculaire liée à l’âge néovasculaire contrôlée anatomiquement de façon sous-optimale (SWIFT)

acronym: SWIFT

lead_sponsor: Novartis Pharma S.A.S


title: Amoxicillin-clavulanate alone or in combination with Ciprofloxacin in Low-Risk Febrile Neutropenic adult Patients:  A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial

acronym: ACACIA

lead_sponsor: CHU DE POITIERS


title:
Traitement endoscopique de l’œsophage hypercontractile par injection de toxine botulinique : étude prospective, randomisée, contrôlée en double aveugle

 Traitement endoscopique de l’œsophage hypercontractile par injection de toxine botulinique : étude prospective, randomisée, contrôlée en double aveugle

acronym:
TIBOH

 TIBOH

lead_sponsor: Hospices Civils de Lyon


title: Poca

acronym: Poca

lead_sponsor: CHU Nantes


title:
A phase IV open-label, multicentre, international trial of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with chronic hepatitis C virus genotype 1 infection and recent injection drug use or receiving opioid substitution therapy

 Essai international en ouvert, multicentrique de phase IV évaluant la prise de paritaprevir/ritonavir, ombitasvir, dasabuvir, avec ou sans ribavirine chez des personnes atteintes d'une infection chronique par le virus de l'hépatite C de génotype 1 avec utilisation récente de drogues injectables ou recevant un traitement de substitution aux opiacés.

lead_sponsor: The Kirby Institute - UNSW Australia


title: Self-help program for hypnotics withdrawal in insomniac patients: A randomized controlled clinical trial.

acronym: PROPERSOM

lead_sponsor: CHU de Bordeaux


title:
Hydroxychloroquine versus placebo : Impact sur les récidives thrombotiques dans le syndrome primaire des antiphospholipides – PAPIRUS

 Hydroxychloroquine versus placebo : Impact sur les récidives thrombotiques dans le syndrome primaire des antiphospholipides – PAPIRUS

acronym:
PAPIRUS

 PAPIRUS


title:
Phase 2 study evaluating MEchanisms of resistance on tumor tissue and Liquid biopsy in patients with EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtinib until and beyond radiological progression : the MELROSE trial

 Étude de phase 2 évaluant les mécanismes de résistance sur le tissu tumoral et sur les biopsies liquides chez des patients avec un cancer du poumon avancé non prétraité, EGFR muté, recevant un traitement par OSIMERTINIB jusqu'à et au-delà de la progression radiologique

acronym: MELROSE

lead_sponsor: CHU de Nantes


title:
.

 Intérêt de la corticothérapie préopératoire sur la cicatrisation après ostéosynthèse des fractures du membre inférieur

acronym: ICOMI

lead_sponsor: CHU de Clermont-Ferrand


title:
Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Mexiletine in Paediatric Patients with Myotonic Disorders Who Have Completed MEX-NM-301 and MEX-NM-302 Studies

 Étude de prolongation ouverte visant à évaluer l’innocuité et l’efficacité à long terme de la mexilétine chez des patients pédiatriques présentant des troubles myotoniques et ayant terminé les études MEX-NM-301 et MEX-NM-302

lead_sponsor: Lupin Europe GmbH


title:
Phase II study evaluating the combination of cetuximab with afatinib as first-line treatment for patients with EGFR mutated Non Small Cell Lung Cancer

 Etude de phase II évaluant l’association de cetuximab à l’afatinib en première ligne de traitement des cancers bronchiques non à petites cellules porteurs d’une mutation du récepteur à l’Epidermal Growth Factor (EGFR)

acronym: ACE : Afatinib plus Cetuximab for EGFR Mutant Lung Cancers

lead_sponsor: IFCT


title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR study)

acronym: BACHELOR

lead_sponsor: CHRU BREST


title: In vivo involvement of the cholinergic and dopaminergic systems in the pathophysiology of apathy.

acronym: ADaChol


title:
Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study

 Essai clinique randomisé multicentrique en double insu comparant l’association de metformine et de méthotrexate au méthotrexate seul chez les patients atteints de polyarthrite rhumatoïde naïfs de méthotrexate

acronym:
METorMET2

 METorMET2


title:
Pilot Study evaluating somatostatin receptor's PET imaging to detect inflammatory phases of myocarditis

 Etude pilote d'évaluation de l'imagerie TEP des récépteurs de la somatostatine

acronym:
DOTAMIR

 DOTAMIR

lead_sponsor: CHRU DE NANCY


title:
18F-Fluorocholine (FCH) versus 18F-Fluorodesoxyglucose (FDG) PET/CT for the detection of lesions in patients with multiple myeloma

 18F-Fluorocholine (FCH) versus 18F-Fluorodesoxyglucose (FDG) PET/CT pour la détection des lésions chez les patients porteurs d’un myélome multiple

acronym:
MIM

 MIM

lead_sponsor: Centre Georges-François Leclerc


title:
Effect and tolerance of ketamine's subcutaneous bolus during painful care, refractory of bedsore, ulcer, vascular wound care in palliative care units.

 Effet et tolérance de bolus sous-cutanés de kétamine lors de soins douloureux réfractaires d'escarres, d'ulcères et de plaies vasculaires en services de soins palliatifs.

acronym:
KETAREF

 KETAREF

lead_sponsor: Groupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)


title: A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease

lead_sponsor: BioMarin Pharmaceutical Inc


title:
/

 Impact d’une supplémentation en vitamine D sur les fonctions immunitaires : Etude chez des sujets âgés de plus de 65 ans vaccinés contre la grippe.

acronym: Supplémentation en vitamine D et réponse immunitaire


title: A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination with Azacitidine Versus Azacitidine Alone for the Treatment of TP53 Mutant Myelodysplastic Syndromes

lead_sponsor: Aprea Therapeutics AB


title: Efficacy of Addition of Naproxen in the Treatment of critically ill Patients Hospitalized for COVID-19 Infection / Enacovid Study

acronym: ENACOVID

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title:
A multicenter, randomised, open-label Phase II study to evaluate the clinical benefit of a post-operative treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy.

 Etude multicentrique de Phase II, randomisée, menée en ouvert visant à évaluer le bénéfice clinique d’un traitement post-opératoire associant radiothérapie + Nivolumab + Ipilimumab versus radiothérapie + Capécitabine chez des patientes atteintes d’un cancer du sein triple négatif et présentant une maladie résiduelle après chimiothérapie néoadjuvante.

lead_sponsor: Centre Léon Bérard


title:
An Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB monotherapy in patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based therapy and harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6

 AB-ORL - Etude de Phase II visant à évaluer l’intérêt clinique d’une monothérapie par abemaciclib chez des patients atteints d’un cancer de la tête et du cou localement avancé ou métastatique après échec d’une thérapie à base de platine et de cetuximab ou anti-EGFR, et présentant une délétion homozygote du gène CDKN2A, et/ou une amplification du gène CCND1 et/ou du gène CDK6.

acronym:
ABORL

 ABORL


title:
CABRAMET - A phase 2 study of cabozantinib in renal cell carcinoma (mRCC) with brain metastases

 CABRAMET - Etude de phase 2 évaluant le cabozantinib dans le traitement du carcinome à cellules rénales métastatique (mRCC) avec métastases cérébrales

acronym:
CABRAMET

 CABRAMET


title: Phase III Study of LI [Multikine®] Plus SOC (Surgery + Radiotherapy or Surgery + Concurrent Radiochemotherapy) in Subjects With Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate vs. SOC Only

acronym: IT-MATTERS

summary: The purpose of this study is to determine whether LI administered in combination with cyclophosphamide, indomethacin and zinc (CIZ) in a multivitamin combination prior to standard of care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) is safe and will increase the overall survival of subjects with previously untreated squamous cell carcinoma of the oral cavity or soft palate at a median of 3 years

ipd_sharing_description: There is no plan

lead_sponsor: CEL-SCI Corporation

location_country:
Malaysia
Romania
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Poland
Thailand
Canada
Sri Lanka
Hungary
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Israel
Belarus
Spain
Turkey

location_facility: Kharkiv Regional Clinical Oncology Center Dept. Of Head and Neck Tumour

location_facility: Sumy Regional Clinical Oncology Dyspensary

location_facility: Henry Ford Health System Henry Ford Hospital

location_facility: Military Medical Academy Clinic for Maxillofacial Surgery

location_facility: Kiev City Clinical Oncology Center of the Main Health Care Dept of Kiev Day Hospital Radiotherapy Dept.

location_facility: Haceteppe University Dept of Otolaryngology - Head and Neck Surgery

location_facility: Ospedale S.G. Moscati Santissima Annunziata

location_facility: Meenakshi Mission Hospital and Research Centre

location_facility: Buddhist Tzu Chi General Hospital, Hualien Branch

location_facility: HNO-Klinik der medizinischen Universitat Graz

location_facility: Kiev City Clinical Oncology Center of the Main Health Care Dept. of the Kiev Day Hospital

location_facility: Clinical Diagnostic Laboratory of Dnepropetrovsk Municipal Institution City Multidisciplinary Clinical Hospital No. 4

location_facility: Sujan Regional Cancer Hospital & Amravati Cancer Foundation

location_facility: Linkou Branch Chang Gung Memorial Hospital

location_facility: LVIV State OncologyRegional treatment and Diagnostic Ceneter

location_facility: Oncology Unit Teaching Hospital Karapitya

location_facility: Clinical Hospital Center Zagreb Kispaticeva 12

location_facility: Centrum Onkologi-Instytut im. Marie Sklodowskiej-Curie

location_facility: Kaohsiung Branch Chang Gung Memorial Hospital

location_facility: Serbia Clinic for ENT and Maxillofacial Surgery

location_facility: Clinical Centre University of Sarejevo Clinic for ENT

location_facility: Cherkasky Regional Oncological Dyspensary Dept. Head and Neck tumour

location_facility: VA Puget Sound Healthcare System & University of WA

location_facility: Clinical center Vojvodina Clinic for ORL

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Acibadem University Maslak Hospital ENT Department

location_facility: Zaporiz'ka Regional Clinical Oncology Dispensary

location_facility: University of Pecs Institute of Oncotherapy

location_facility: Clinical Centre Vojvodina Clinic for Maxillofacial Surgery

location_facility: St. Josephs Healthcare Department of Surgery

location_facility: Budget Institution of Healthcare of Omsk Region Clincal Oncology Dispensary

location_facility: Faculty of Dental Medicine Clinic for Maxillofacial Surgery

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Khon Kaen University Dept of Otolaryngology

location_facility: University of Debrecen Medical and Health Scioence Centre

location_facility: Medical College Of South Carolina MSC550

location_facility: Wojewodzki Szpital Specjalistyczny im Kopernika

location_facility: Uniwersitecki Szpital Kliniczny Klinika Otolaryngologii Chirugii Glowy i Szxyi

location_facility: N.N. Alexandrov Research Istitute of Oncology and Medical Radiology

location_facility: Grigoriev Institute for Medical Radiology of National Academy of Medical Science of Ukraine Dept. of Remote, Combined Radiation and Complex Therapy

location_facility: Clinic for Stomatology department for maxillofacial Surgery

location_facility: National Cancer Institute Dept of Clinical Oncology & Radiotherapy

location_facility: Dept of Head and Neck Surgery School of Medical Sciences Univ. Sains

location_facility: V.N. Cancer Center G. Kuppuswamy Naidu Memorial Hospital

location_facility: Weilkopolskie Centrum Onkologii Klinika Chirurgii Glowy Szye Onkologii Laryngologiczne

location_facility: Simmons Cancer Institute at Southern Illinois University

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Consorsio Hospital General Universitario de valencia

location_facility: Clincal Center Serbia Clinic for Oral and Maxillofacial Surgery

location_facility: Samodzielny Publiczny Szpital Kliniczny Klinika Otolarryngologii I Onkologii Laryngologicznej

location_facility: Szpital Specialistyczny im. Ludwika Rydgiera

location_facility: University of Szeged Dept of Oral and Maxillofacial Surgery

intervention_type: Dietary Supplement


title: Essai de phase II : Folfiri.3 (CPT-11/acide folinique/5-FU) / gemzar en traitement sequentiel des cancers du pancréas métastatiques non pré-traités

acronym: firgem

lead_sponsor: Ageo