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


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.

source: euctr

lead_sponsor: Debiopharm S.A.

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


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: Interaction médicamenteuse entre la Colchicine et les inhibiteurs de calcineurine chez les patients transplantés rénaux

acronym: COLCHINCAL

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


title: Etude du rizatriptan comme prémédication antalgique lors d’une pulpite irréversible.

lead_sponsor: CHU de Clermont-Ferrand


title: Douleur aiguë modérée en préhospitalier : Etude prospective randomisée en double aveugle comparant le mélange équimolaire oxygène protoxyde d’azote au placebo

lead_sponsor: CHU TOULOUSE


title: Validation de l’effet antiviral du Midodrine identifié par l’analyse de la signature transcriptomique cellulaire de l’infection par les virus influenza A

acronym: FLUMED

lead_sponsor: Hospices Civils de Lyon


title: Prévention par une héparine de bas poids moléculaire, l'enoxaparine, des complications maternelles et périnatale chez les patientes ayant un antécédent de prééclampsie sévère avant 34 semaines d'aménorrhée: Essai contrôlé randomisé multicentrique.

acronym: HEPEPE

status: Completed

status_simplified: Completed


title: Comparaison de l’effet antisécrétoire d’une dose unique de rabeprazole 20 mg et d’omeprazole 20 mg chez des sujets obèses

acronym: Oberab

lead_sponsor: CHU de Nantes


title: ETUDE CLINIQUE COMPARANT L’EFFICACITE DU PARACETAMOL PERMUQUEUX BUCCAL 125 MG VERSUS CELLE DU PARACETAMOL INJECTABLE 1 G, EN PERFUSION LENTE IV CHEZ DES PATIENTS SOUFFRANT DE DOULEUR AIGUË.

acronym: ParaJug


title: Traitement de la Progéria de Hutchinson-Gilford par l’association de pravastatine (Vasten®) et d’acide zolédronique (Zométa®)

lead_sponsor: Assistance Publique Hopitaux de marseille


title: OPTIMISATION DE L’EVALUATION DE LA FONCTION  SURRENALIENNE APRES ARRET D’UNE CORTICOTHERAPIE PROLONGEE

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: METAFORE : Maladie de Rendu-Osler :  Etude de l’Efficacité et de la tolérance du Bevacizumab utilisé pour le traitement des formes hépatiques sévères. Etude de phase II

acronym: METAFORE

lead_sponsor: HOSPICES CIVILS DE LYON


title: Impact du remplissage vasculaire sur l’œdème pulmonaire mesuré par la clairance alvéolaire chez des patients atteints de SDRA.

acronym: IROCA

lead_sponsor: CHU Clermont-Ferrand


title: Neoadjuvant phase II trial combining [3 FEC 100 followed by 3 docetaxel associated with trastuzumab plus pertuzumab] or [6 docetaxel, carboplatin associated with trastuzumab plus pertuzumab] according to TOP2A status in patients with T1c operable, HER2-positive breast cancer. Identification of pathological Complete Response (pCR) predictive factors.

lead_sponsor: UNICANCER


title: Héparinothérapie pour la circulation extracorporelle en chirurgie cardiaque chez les patients obèses : étude prospective évaluant une posologie basée sur le poids idéal au C.H.U. de Strasbourg

acronym:
HEPOIRINE

 HEPOIRINE

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title:
PHASE I/II DE RADIOCHIMIOTHERAPIE DANS LES CANCERS DE L’ŒSOPHAGE DU SUJET AGE. OSAGE

 PHASE I/II DE RADIOCHIMIOTHERAPIE DANS LES CANCERS DE L’ŒSOPHAGE DU SUJET AGE. OSAGE

acronym:
OSAGE

 OSAGE

lead_sponsor: Centre Hospitalier Régional Universitaire de Besançon


title:
Lévétiracétam pour le traitement en première intention des convulsions du nouveau-né : étude de phase II

 Lévétiracétam pour le traitement en première intention des convulsions du nouveau-né : étude de phase II

lead_sponsor: CHRU TOURS

status_simplified: Unknown


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:
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.

lead_sponsor: ARCAGY-GINECO


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: 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:
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:
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 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:
.

 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:
Impact of dexmedetomidine on preventive noninvasive ventilation in thoracic trauma

 Impact de la dexmedetomidine sur la ventilation non invasive préventive chez le traumatisé thoracique

acronym:
VENDETTA

 VENDETTA

lead_sponsor: University Hospital Grenoble


title:
A prospective, multicenter, randomized, open-label study of 12 week duration to evaluate the effect of VILDagliptin added to insulin on glycaemic control in haemoDIALyzed patients with type 2 diabetes: probe analysis of CGM

 Etude prospective randomisée multicentrique d’évaluation de la VILDagliptine associée à l’insuline sur le contrôle glycémique chez les patients hémoDIALysés diabétiques de type 2 : étude VILDDIAL

acronym:
VILDDIAL

 VILDDIAL

lead_sponsor: Hôpitaux Universitaires de Strasbourg


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:
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

lead_sponsor: CHU de Rennes


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:
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:
Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients

 Optimisation de la préparation cutanée pour réduire la colonisation à Cutibacterium acnes dans des prélèvements superficiels et profonds lors de la chirurgie prothétique de l'épaule chez l'homme

acronym: OPRICA

lead_sponsor: CHU de Nantes


title:
/

 Kétamine et douleur neuropathique

acronym:
/

 KETAPAIN

lead_sponsor: CHU CLERMONT-FERRAND


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: 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:
A  Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2

 Essai multicentrique, randomisé contre placebo, de l’utilisation du Nintedanib dans le traitement de la bronchiolite obliterante/dysfonction chronique du greffon chez les patients transplantés pulmonaires.

acronym: INFINITX BOS

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


title: Assessment of Endothelial VAsomotricity after treatment by Nicotinic Acid in Patients presenting a recent Acute Coronary Syndrome

acronym: EVAN ACS

lead_sponsor: French Society of Cardiology


title: Etude de la réduction des poussées de lupus érythémateux systémique par adaptation de la posologie de l'hydroxychloroquine à sa concentration sanguine. Etude randomisée multicentrique nationale.

acronym: PLUS


title: Etude de phase III randomisée comparant deux modes d’administration des facteurs de croissance (G-CSF) non pégylés dans la prévention secondaire des neutropénies sévères

acronym: G-CSF 3/7

lead_sponsor: CENTRE ANTOINE LACASSAGNE


title: L’administration d’ondansetron dans le cadre d’une prophylaxie des nausées et vomissements postopératoires réduirait-il l’effet analgésique du paracétamol ?

lead_sponsor: Centre Hospitalier Universitaire de Nancy


title: Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus


title: Efficacité d’un traitement par l’association amlodipine et valsartan en monoprise vespérale ou matinale, chez des Patients présentant une HTA Essentielle moyenne à modérée, non contRôlée par amlodipine 5mg en mesure ambulatoire de la pression arTérielle: Etude ExPERT

acronym: ExPERT

lead_sponsor: Novartis Pharma S.A.S.


title: Exploration de l'influence du polymorphisme *2 du gène codant pour le cytochrome 2C19 sur la réponse au clopidogrel chez le jeune coronarien

acronym: CLOVIS 2


title: A phase II study evaluating the efficacy and safety of the farnesyltransferase inhibitor ZARNESTRA® (R115777, tipifarnib) in patients with relapsed , refractory or progressive mantle cell lymphoma not appropriate for autologous bone marrow transplantation

acronym: Zarnestra® (tipifarnib) for oral administration

lead_sponsor: GELA


title: Durée de Traitement des Pyélonéphrites aiguës - Etude multicentrique, de non infériorité, randomisée évaluant deux durées de traitement antibiotique (5 versus 10 jours) dans les pyélonéphrites aiguës (PNA) communautaires non compliquées de la femme jeune. Etude DTP

acronym: DTP


title: Etude de phase II, multicentrique, en ouvert, évaluant l'efficacité d'un traitement par Sutent (sunitinib) chez des patients porteurs de métastases cérébrales d'origine rénale non traitées antérieurement ou en reprise évolutive après radiothérapie ou chirurgie

acronym: Sutent Métastases cérébrales

lead_sponsor: Institut Claudius Regaud


title: Influence du traitement par glitazones sur les Phospholipases A2 et sur l'effet des Lipoprotéines de haute densité (HDL) sur la réactivité artérielle, au cours du diabète de type 2

lead_sponsor: CHU DIJON


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

acronym: EPOPEE

lead_sponsor: Hospices Civils de Lyon


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


intervention_type: Drug

lead_sponsor: Seagen Inc.

summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

ReferenceType: result

ReferenceCitation: Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.

ReferenceType: derived

ReferenceCitation: Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ReferenceCitation: Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.

evidence: open (via free pdf)

sponsor_collaborators:
Seagen Inc.
Millennium Pharmaceuticals, Inc.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: Washington University School of Medicine

title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

primary_purpose: Treatment

type: EudraCT Number

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Italy
Belgium
United States
Canada
France


study_start_date_type: Actual

lead_sponsor: PTC Therapeutics

summary: Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 10-15% of boys with the disease. Ataluren (PTC124) is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b extension trial that will evaluate the long-term safety of ataluren (PTC124) in boys with nonsense mutation DMD/BMD, as determined by adverse events and laboratory abnormalities. The study will also assess changes in walking, muscle function, and other important clinical and laboratory measures.

ReferenceType: background

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44. doi: 10.1177/0091270006297140.

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. doi: 10.1038/nature05756. Epub 2007 Apr 22.

sponsor_collaborators:
PTC Therapeutics
Genzyme, a Sanofi Company

location_facility: UCL Instititute of Child Health, Dubowitz

location_facility: Department of Rehabilitation, The Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: U.O. Complessa di Neuropsichiatria Infantile-Policlinico A. Gemelli-Universita Cattolica

location_facility: Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Groupe Hospitalier Pitie-Salpetriere, Institut de Myologie

location_facility: University of Iowa Children's Hospital, Division of Child Neurology

location_facility: University of Essen - Clinic for Children

location_facility: Robert Jones & Agnes Hunt Orthopaedic Hospital

status: Terminated

title: A Phase 2B Extension Study of PTC124 in Subjects With Nonsense-Mutation-Mediated Duchenne and Becker Muscular Dystrophy

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

ipd_sharing: No


title: A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: Phase III Metastatic Pancreatic Cancer

design_allocation: Randomized

ReferenceCitation: Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

ReferenceCitation: Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28. Erratum In: Br J Cancer. 2016 Oct 25;115(9):e13.

ReferenceCitation: Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16. Erratum In: Adv Ther. 2016 Nov 24;:

ReferenceCitation: Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

ReferenceCitation: Vogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.

ReferenceCitation: Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.

ReferenceCitation: Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.

ReferenceCitation: Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

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

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repository_institution: Würzburg University - Online Publication Service of Würzburg University

ReferenceCitation: Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

ReferenceCitation: Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

ReferenceCitation: Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

ReferenceCitation: Vogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

ReferenceCitation: Von Hoff DD, Cridebring D, Tian OY, Han H, Bhore R, Franco T, Ondovik MS, Louis CU. Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer. Oncologist. 2021 Apr;26(4):e704-e709. doi: 10.1002/onco.13645. Epub 2021 Jan 11.

ReferenceCitation: McCleary-Wheeler AL, McWilliams R, Fernandez-Zapico ME. Aberrant signaling pathways in pancreatic cancer: a two compartment view. Mol Carcinog. 2012 Jan;51(1):25-39. doi: 10.1002/mc.20827.

location_country:
Germany
Italy
Australia
Austria
Belgium
United States
Spain
Canada
Ukraine
Russian Federation
France

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Sidney Kimmel Comphrensive Cancer Center, John Hopkins University

location_facility: UAB Comprenhensive Cancer Center at University of Alabama

location_facility: Texas Oncology, PA/ Methodist Charlton Cancer Center

location_facility: Haemotology & Oncology Australasia (HOCA)

location_facility: Med Radiological Centre of the Russian Academy of Med Sciences

location_facility: Centre Hospitalier de L'Universite de Montreal St-Luc

location_facility: Lviv Regional Diagnostics and Treatment and Diagnostics Onc Ctr

location_facility: Zaporizhia Medical Academy of Postgraduate Education

location_facility: Adelaide Cancer Centre (T/A Ashford Cancer Ctr)

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Volyn Regional Oncology Center Department of Oncochemotherapy

location_facility: The Center for Cancer and Blood Disorders

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: Praxis für Innere Medizin, Dr. Oettle Helmut

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Russian Research Ctr of Surgery n.a. B.V. Petrovskiy under the Russian Academy of Med Sciences

location_facility: South Texas Oncology and Hematology, P.A

location_facility: St. Mary Medical Center Hem-Onc Group, PC

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Pyatigorsk Affiliate of Stavropol Regional Onc Ctr

location_facility: Russian Research Ctr for Radiology and Surgical Technologies

location_facility: TGEN Clinical Research Services at Scottsdale Healthcare

location_facility: Haematology Oncology Clinics of Australasia-Gold Coast

location_facility: Russian Res Ctr of Radiology under the Fed Agency for Hi-Tech Med Care

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: I.R.C.C.S. "Giovanni Paolo II" - Istituto Oncologico

location_facility: E. O. Ospedali Galliera, Struttura Complessa Oncologia Medica

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: National Institute of Cancer, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: The Center for Cancer and Hematologic Disease

location_facility: Central Clinical Hosp of the President of the Russian Federation

location_facility: Cancer Center of Excellence/University of MA Medical School

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Northern Arizona Hematology and Oncology Associates-AOA

location_facility: Azienda Ospedaliero universitaria Pisana

location_facility: Fairfax-Northern Virginia Hematology-Oncology, P.C.

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Surgery Center

location_facility: Kyiv City Clinical Hospital #10, Center for Hepatic, Bile Duct and Pancreatic Surgery

location_facility: Cancer Care & Hemaotology Specialists of Chicagoland

location_facility: The University of Texas Medical School at Houston

location_facility: Moscow City Clinical Hosp #57 Chemotherapy Dept

location_facility: Clearview Cancer Institute Oncology Specialities, P.C.

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Kirovohrad Regional Oncology Center, Department of Chemotherapy

location_facility: Arizona Cancer Center, University of Arizona

location_facility: St. Petersburg State Med Academy n.a.Mechnikov

location_facility: Arcispedale Santa Maria Nuova, Unità Operativa di Oncologia Medica

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: University of Oklahoma Health Science Center

location_facility: Desert Hematology Oncology Medical Group, Inc.


title: Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

acronym: ODiXaHip

summary: Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

primary_purpose: Prevention

lead_sponsor: Bayer

location_country:
Germany
Poland
Israel
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
France


title: An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

acronym: GAUDI

summary: This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

publisher_dissemination: Wiley

ReferenceCitation: Grigg A, Dyer MJ, Diaz MG, Dreyling M, Rule S, Lei G, Knapp A, Wassner-Fritsch E, Marlton P. Safety and efficacy of obinutuzumab with CHOP or bendamustine in previously untreated follicular lymphoma. Haematologica. 2017 Apr;102(4):765-772. doi: 10.3324/haematol.2016.152272. Epub 2016 Dec 23.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Leicester - Leicester Research Archive

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

ReferenceCitation: Radford J, Davies A, Cartron G, Morschhauser F, Salles G, Marcus R, Wenger M, Lei G, Wassner-Fritsch E, Vitolo U. Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000). Blood. 2013 Aug 15;122(7):1137-43. doi: 10.1182/blood-2013-01-481341. Epub 2013 Jul 10.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Australia
Spain
France


lead_sponsor: Novartis Pharmaceuticals

summary: This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

title: An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients

location_country:
France
Germany
Italy
Colombia
Slovakia
Norway
Argentina
Singapore
Australia
Brazil
Netherlands
Austria
Belgium
Switzerland
Spain
Taiwan
Czech Republic


title: A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

summary: This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Australia
Brazil
Netherlands
Austria
Belgium
Mexico
United States
Spain
Canada
France


type: Other Identifier

title: A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)

acronym: PRONTO

summary: The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.

lead_sponsor: The Medicines Company

location_country:
United States
Germany
France

location_facility: Stony Brook University and Medical Center

location_facility: Washington University School of Medicine

location_facility: Hopital AP-HP Lariboisiere Urgencies-SMUR

location_facility: Louisiana State University Health Sciences Center - Emergency Medicine


summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.

ReferenceCitation: Kerem E, Konstan MW, De Boeck K, Accurso FJ, Sermet-Gaudelus I, Wilschanski M, Elborn JS, Melotti P, Bronsveld I, Fajac I, Malfroot A, Rosenbluth DB, Walker PA, McColley SA, Knoop C, Quattrucci S, Rietschel E, Zeitlin PL, Barth J, Elfring GL, Welch EM, Branstrom A, Spiegel RJ, Peltz SW, Ajayi T, Rowe SM; Cystic Fibrosis Ataluren Study Group. Ataluren for the treatment of nonsense-mutation cystic fibrosis: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Respir Med. 2014 Jul;2(7):539-47. doi: 10.1016/S2213-2600(14)70100-6. Epub 2014 May 15.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

sponsor_collaborators:
PTC Therapeutics
Cystic Fibrosis Foundation

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

title: A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis

type: Other Grant/Funding Number

location_country:
Germany
Italy
Israel
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation

summary:
The purpose of this study is to determine whether a single administration of QPI-1002 (also known as I5NP) can prevent DGF in patients undergoing deceased donor kidney transplantation. In this Phase I /II study, patients who are undergoing renal transplantation with organs from DCD donors, ECD donors or SCD donors with ≥ 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP (Part A) and clinical activity of I5NP administration (Part B). Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies.

Part A will be a randomized, dose escalation study to determine the highest or maximum tolerated dose (MTD). Part A will enroll 40 patients at approximately 20 sites; patients will be randomized to receive either I5NP or placebo in a ratio of 8:2 in each cohort (cohorts 1-4).

Part B will utilize the dose identified in Part A to further evaluate, in a double-blind manner, the safety, and clinical activity of I5NP. In Part B, up to 326 patients will participate at approximately 60 sites; up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo.

lead_sponsor: Quark Pharmaceuticals

location_country:
Germany
United States
Spain
Canada
France

location_facility: QE II Capital District Health Authority, Halifax

location_facility: Transplant Research Institute (TRI; formerly NIT)

location_facility: University of Colorado Health Science Center


acronym: STEPS

lead_sponsor: Shire

summary: Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study. Clin Nutr. 2020 Aug;39(8):2479-2486. doi: 10.1016/j.clnu.2019.11.001. Epub 2019 Nov 9.

ReferenceCitation: Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure. Gastroenterology. 2018 Mar;154(4):874-885. doi: 10.1053/j.gastro.2017.11.023. Epub 2017 Nov 22.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

ReferenceCitation: Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17.

oa_host_type: closed

publisher_dissemination: Informa

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghofer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28.

ReferenceCitation: Berghofer P, Fragkos KC, Baxter JP, Forbes A, Joly F, Heinze H, Loth S, Pertkiewicz M, Messing B, Jeppesen PB. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL) scale. Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12.

ReferenceCitation: Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11.

sponsor_collaborators: Shire Nycomed

location_facility: Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale

location_facility: Critical Care Research, Royal Alexandra Hospital

location_facility: Polyclinic Family and Specialty Medicine Facility

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: Hôpital Croix Rousse Unité de Nutrition Clinique Intensive

location_facility: Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette

location_facility: Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii

location_facility: Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: University Health Network - Toronto General Hospital

title: A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Netherlands
United States
Spain
Canada
France


title: An Open-label Study to Determine the Effect of R1507 Plus Tarceva (Erlotinib) on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) With Progressive Disease After Clinical Benefit to Second or Third Line Tarceva Monotherapy.

summary: This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

location_country:
United States
Canada
Poland
France


lead_sponsor: H. Lundbeck A/S

summary: The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.

title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia

location_country:
Poland
Indonesia
Hong Kong
Spain
Thailand
Czech Republic
Philippines
France


title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

acronym: SPARTAN

summary: The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

ReferenceCitation: Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme LLC

location_country:
United States
Argentina
France

location_facility: Tarrant County Infectious Disease Associates


title: A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (AromasinÂ®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)

summary: The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).

location_country:
Ireland
Poland
United Kingdom
Sweden
United States
Spain
Czech Republic
France

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Compassionate Cancer Care Medical Group Inc


title: A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults

summary: The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

publisher_dissemination: American Society for Microbiology

location_country:
Poland
India
Romania
Lebanon
United States
Bulgaria
Russian Federation
France

location_facility: Multiprofile Hospital for Active Trt Emergency Med

location_facility: CCB Ministry of Interior Clinical of Surgery

location_facility: Amrita Institute of Medical Sciences, Cochin

location_facility: UMHAT Sveti Georgi 3rd Clinical of Surgery

location_facility: Cedars-Sinai Medical Center Dept of Surgery

location_facility: Hammound Hospital University Medical Center

location_facility: UMHAT Queen Joanna-ISUL, Clinical of Surgery


lead_sponsor: Takeda

summary: The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.

ReferenceCitation: Henigsberg N, Mahableshwarkar AR, Jacobsen P, Chen Y, Thase ME. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012 Jul;73(7):953-9. doi: 10.4088/JCP.11m07470.

ReferenceCitation: McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

publisher_dissemination: Physicians Postgraduate Press, Inc

sponsor_collaborators:
Takeda
H. Lundbeck A/S

title: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

type: Registry Identifier

location_country:
Germany
Lithuania
Poland
United Kingdom
Australia
Netherlands
Korea, Republic of
Latvia
Malaysia
South Africa
Taiwan
Ukraine
Czech Republic
Russian Federation
France


acronym: ASPIRE

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

summary: To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia

location_country:
Finland
Poland
Argentina
Australia
Thailand
Croatia
Chile
Serbia
France
Slovakia
Hungary
United States
India
Romania
Belgium
Malaysia
Estonia
Puerto Rico
Philippines
Norway
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

summary: The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

location_country:
Germany
Poland
Hungary
United States
France

location_facility: Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy

location_facility: SZPZOZ Szpital Zachodni im. Jana Pawla II

location_facility: Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM

location_facility: NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: NZCZ Regionalna Poradnia Diabetologiczna

location_facility: Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca

location_facility: Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza


title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MS

acronym: ORACLE MS

summary: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS.

ReferenceCitation: Oh J, Walker B, Giovannoni G, Jack D, Dangond F, Nolting A, Aldridge J, Lebson LA, Leist TP. Side effects that occurred early in people with multiple sclerosis during the first year of treatment with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Feb 1;12(1):1-7. doi: 10.2217/nmt-2021-0041. Epub 2022 Jan 12.

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

ReferenceCitation: Giovannoni G, Coyle PK, Vermersch P, Walker B, Aldridge J, Nolting A, Galazka A, Lemieux C, Leist TP. Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets. Front Immunol. 2021 Dec 24;12:763433. doi: 10.3389/fimmu.2021.763433. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

repositories_concat: PubMed Central;ddd.uab.cat

repositories_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

publisher_dissemination: Springer-Nature

ReferenceCitation: Freedman MS, Leist TP, Comi G, Cree BA, Coyle PK, Hartung HP, Vermersch P, Damian D, Dangond F. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study. Mult Scler J Exp Transl Clin. 2017 Oct 9;3(4):2055217317732802. doi: 10.1177/2055217317732802. eCollection 2017 Oct-Dec.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: SAGE Publications

ReferenceCitation: Leist TP, Comi G, Cree BA, Coyle PK, Freedman MS, Hartung HP, Vermersch P, Casset-Semanaz F, Scaramozza M; oral cladribine for early MS (ORACLE MS) Study Group. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial. Lancet Neurol. 2014 Mar;13(3):257-67. doi: 10.1016/S1474-4422(14)70005-5. Epub 2014 Feb 4.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Finland
Germany
Poland
Argentina
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Czechia
Canada
Serbia
France
Portugal
United States
Ukraine
North Macedonia
India
Romania
Lebanon
Belgium
Estonia
Italy
Norway
Singapore
United Kingdom
Austria
United Arab Emirates
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Sweden

location_facility: Neurology & Neurological Association of Tacoma

location_facility: State Medical Institution " Jursk Regional Clinical Hospital"

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: State Medical Institution "Republican Rehabilitation Clinic of Tatarstan Ministry of Health"

location_facility: Villa Sofia Hospital Azienda Ospedaliera Villa Sofia P.zza Salerno e Resuttana 1

location_facility: Neurologian Klinikka Seinajoen Keskussairaala

location_facility: State Healthcare Institution "Kaluga Regional Hospital"

location_facility: Department of Neurology, Asan Medical Center, 388-1 Pungnap 2-dong, Songpa-gu

location_facility: Chang Gung Medical Foundation- Linkou Branch No5

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Regionsykehuset I Trondheim, Nevrologisk avd.

location_facility: St. Petersburg State Healthcare Institution "Multifield City Hospital #2"

location_facility: National Neuroscience Institute (TTSH Campus)

location_facility: State Educational Institute of Higher Professional Education "I.M. Sechenov Moscow Medical Academy of Roszdrav" Russia based on A. Ya. Kozhevnikov Nervous Disease Clinic

location_facility: Multiple Sclerosis Center of Northeastern NY

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: CHU de Liege - Domaine Universitaire du Sart Tilman,

location_facility: Yonsei University Medical Center, Department of Neurology, Yonsei University Medical Center

location_facility: Regional State Healthcare Institution "State Smolensk Region Clinical Hospital"

location_facility: Institute of Human Brain of Russian Academy of Science Dept. of Multiple Sclerosis

location_facility: State Healthcare Institution "Rostov Region Clinical Hospital"

location_facility: Municipal Treatment Prophylactic Institution "City Hospital #33"

location_facility: Universitaetsklinikum und Medizinische Fakultaet Heidelberg

location_facility: National Cancer Center, Department of Neurology,

location_facility: Amrita Institute of Medical Sciences and Research

location_facility: State institution Science Research Institute Clinical and Experimental Lymphology of Russian Academy of Medical Sciences

location_facility: Hospital for Prevention and Treatment of Cerebro-Vascular Diseases

location_facility: State Educational Institution of Higher Professional Education "Samara State Medical University of Roszdrav" on State Healthcare Institution "Samara Regional Clinical Hospital named after M. I. Kalinin"

location_facility: Department of Neurology, 50 Ilwon-dong, Gangnam-gu

location_facility: Closed joint-stock society Medical sanitary unit "Nephtaynik" based the hospital

location_facility: Institue for Clinical Radiology of the State Establishment "Research Centre for Radiation Medicine of the AMS of Ukraino" Depart of Radiation Psychoneurology

location_facility: Vladimir Regional State Healthcare Institution "Regional Clinical Hospital"

location_facility: State Established "Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine", Depart of Neurinfections and Multiple Sclorosis

location_facility: Multiple Sclerosis Center Drive, Neurology Suite 701

location_facility: Seoul National University Hospital, Department of Neurology

location_facility: State Educational Institution of Higher Professional Education "Saratov State Medical University of Roszdrav" based on Clincial Hosptial #3 of Saratov State Medical University

location_facility: Moscow State Healthcare Institution City Clinical Hospital #11

location_facility: S. Khechinashvili Tbilisi State Medical University

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Hope Research Institute Medical Plaza LLC Desert Hills

location_facility: "Dr. Carol Davilla" Military Clinical Hospital

location_facility: MS Center of Brevard MIMA Centry Research Associates

location_facility: Fakultní nemocnice s poliklinikou Ostrava

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Non-State Healthcare Institution "Central Clinical Hospital #2 named after N.A. Semasko of Russian Railways"

location_facility: State Educational Institution of Higher Professional Education "Military Medical Academy named after S. M. Korov of Dept of Defense of Russian Federation based on Clinic of Neurology of State Institution

location_facility: State Educational Institute of Higher Professional Education "Rostov State Medical University of Roszdrav"

location_facility: Municipal Healthcare Institution "Yaroslavi Clinical Hospital #8"

location_facility: Azienda Sanitaria Ospedaliera San Luigi Gonzaga

location_facility: Vinnylsia Regional Psychoneurological Hosptial Named After O. I Yushchenko, Neurological Depart, Vinnytsia National Medical University Named After M. I. Pirogov, Chair of Neurology

location_facility: Wojewodzki Szpital Specjalistyczny Oddział Neurologii z Pododdziałem Udarowym

location_facility: Comprehensive MS Care Clinic at South Shore Multiple Sclerosis

location_facility: Turun Yliopistollinen Keskussairaala Rakennus 3 1

location_facility: Municipal Healthcare Institution "City Clinical Hospital #3"

location_facility: Helse Bergen HF Kvinneklinikken Haukeland Universitetssykehus Jonas

location_facility: State Educational Institution of Higher Professional Education "Siberian State Medical University of Roszdrav"

location_facility: International Clinic and Hospital, Neurology

location_facility: Ospedale Binaghi Centro Sclerosi Multipla

location_facility: University of Medicine and Dentistry of New Jersey School of Neurology

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Federal State Institution " Siberian Reginal Medical Center of Roszdarv"

location_facility: State Healthcare Institution "Kemerovo Regional Clinical Hospital"

location_facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

location_facility: University of Colorado at Denver Health Sciences


title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

ReferenceCitation: Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: R-Pharm

location_country:
Germany
Italy
Argentina
Australia
United States
Korea, Republic of
Spain
Taiwan
Russian Federation
France

location_facility:
Local Institution
Uof Md,Greenebaum Cancer Ctr.
Scripps Cancer Center


lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

summary: To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

title: A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

location_country:
Germany
Poland
Czechia
Serbia
France
Slovenia
Colombia
Portugal
Slovakia
United States
Ukraine
India
Romania
Belgium
Philippines
Italy
United Kingdom
Spain
South Africa
Russian Federation


title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

summary: The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

lead_sponsor: Janssen-Cilag International NV

location_country:
Finland
Germany
Norway
United Kingdom
Denmark
Sweden
Netherlands
Switzerland
Belgium
Spain
France


lead_sponsor: Novo Nordisk A/S

summary: The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

ReferenceCitation: Inbal A, Oldenburg J, Carcao M, Rosholm A, Tehranchi R, Nugent D. Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency. Blood. 2012 May 31;119(22):5111-7. doi: 10.1182/blood-2011-10-386045. Epub 2012 Mar 26.

ReferenceCitation: Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornoe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

title: A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

location_country:
Finland
Germany
Italy
Israel
United Kingdom
Switzerland
Austria
United States
Spain
Canada
France


summary: The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

title: A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder

location_country:
Germany
Lithuania
Poland
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Latvia
Malaysia
Croatia
South Africa
Taiwan
Ukraine
Serbia
Russian Federation
France


title: A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men

summary: Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

ReferenceCitation: Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf). 2011 Dec;75(6):836-43. doi: 10.1111/j.1365-2265.2011.04152.x.

ReferenceCitation: Muram D, Ni X. Utility of a single serum testosterone measurement to determine response to topical testosterone replacement in hypogonadal men. Curr Med Res Opin. 2016;32(2):263-9. doi: 10.1185/03007995.2015.1117434. Epub 2015 Dec 15.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
France
United Kingdom
Australia
United States
Sweden

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.


acronym: ALSYMPCA

lead_sponsor: Bayer

summary: ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

ReferenceCitation: Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.

ReferenceCitation: Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland OS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.

ReferenceCitation: Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.

publisher_dissemination: Oncology Nursing Society (ONS)

ReferenceCitation: Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061.

ReferenceCitation: Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132.

ReferenceCitation: Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6.

ReferenceCitation: Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4.

publisher_dissemination: Springer

ReferenceCitation: Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.

publisher_dissemination: Portico

ReferenceCitation: Parker C, Zhan L, Cislo P, Reuning-Scherer J, Vogelzang NJ, Nilsson S, Sartor O, O'Sullivan JM, Coleman RE. Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial. Eur J Cancer. 2017 Jan;71:1-6. doi: 10.1016/j.ejca.2016.10.020. Epub 2016 Dec 6.

repository_institution: Queen's University Belfast - Research Portal

title: A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

location_country:
Germany
Poland
Australia
Brazil
Canada
France
Czech Republic
Slovakia
Hong Kong
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Spain
Israel


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

acronym: ALS

summary: The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Germany
Italy
Hungary
Israel
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze

location_facility: London Health Sciences Centre Motor Neuro Diseases Clinic

location_facility: C.H.U. La Timone - Service de Neurologie

location_facility: Hopital La Pitie Salpetriere - Federation de Neurologie

location_facility: Columbia University - Neurology Institute

location_facility: CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center

location_facility: Semmelweis University, Department of Neurology

location_facility: University of Kansas Medical Center - Dept of Neurology

location_facility: C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques

location_facility: Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik

location_facility: Academic Hospital University of Leuven - ALS dept

location_facility: Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik

location_facility: Massachusetts General Hospital-Neurology Clinical Trials Unit


title: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

acronym: EchoCRT

summary: The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.

ReferenceCitation: Varma N, Sogaard P, Bax JJ, Abraham WT, Borer JS, Dickstein K, Singh JP, Gras D, Holzmeister J, Brugada J, Ruschitzka F. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial. J Am Heart Assoc. 2018 May 27;7(11):e009592. doi: 10.1161/JAHA.118.009592. Erratum In: J Am Heart Assoc. 2018 Jun 17;7(12):

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

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: Leiden University - Leiden Repository

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Tayal B, Gorcsan J 3rd, Bax JJ, Risum N, Olsen NT, Singh JP, Abraham WT, Borer JS, Dickstein K, Gras D, Krum H, Brugada J, Robertson M, Ford I, Holzmeister J, Ruschitzka F, Sogaard P. Cardiac Resynchronization Therapy in Patients With Heart Failure and Narrow QRS Complexes. J Am Coll Cardiol. 2018 Mar 27;71(12):1325-1333. doi: 10.1016/j.jacc.2018.01.042.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Steffel J, Varma N, Robertson M, Singh JP, Bax JJ, Borer JS, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J, Brugada J, Abraham WT, Ruschitzka F. Effect of Gender on Outcomes After Cardiac Resynchronization Therapy in Patients With a Narrow QRS Complex: A Subgroup Analysis of the EchoCRT Trial. Circ Arrhythm Electrophysiol. 2016 Jun;9(6):e003924. doi: 10.1161/CIRCEP.115.003924.

ReferenceCitation: Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, Dickstein K, Ford I, Gorcsan J 3rd, Gras D, Krum H, Sogaard P, Holzmeister J; EchoCRT Study Group. Cardiac-resynchronization therapy in heart failure with a narrow QRS complex. N Engl J Med. 2013 Oct 10;369(15):1395-405. doi: 10.1056/NEJMoa1306687. Epub 2013 Sep 2.

repository_institution: St George's University of London - St George's Online Research Archive

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau

location_facility: The Ohio State University Richard M. Ross Heart Hospital

location_facility: Michigan Heart, P.C./ St. Joseph Mercy Hospital

location_facility: Promedica Northwest Ohio Cardiology Consultants

location_facility: IKEM - Institute for Clinical and Experimental Medicine

location_facility: University Hospitals of Coventry and Warwickshire

location_facility: Thoracic & Cardiovascular Healthcare Foundation

location_facility: Jefferson Heart Institute, Thomas Jefferson University Hospital


lead_sponsor: Amgen

summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

ReferenceCitation: Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. doi: 10.1016/S1470-2045(13)70277-8. Epub 2013 Jul 16.

ReferenceCitation: Martin-Broto J, Cleeland CS, Glare PA, Engellau J, Skubitz KM, Blum RH, Ganjoo KN, Staddon A, Dominkus M, Feng A, Qian Y, Braun A, Jacobs I, Chung K, Atchison C. Effects of denosumab on pain and analgesic use in giant cell tumor of bone: interim results from a phase II study. Acta Oncol. 2014 Sep;53(9):1173-9. doi: 10.3109/0284186X.2014.910313. Epub 2014 May 19.

ReferenceCitation: Rutkowski P, Ferrari S, Grimer RJ, Stalley PD, Dijkstra SP, Pienkowski A, Vaz G, Wunder JS, Seeger LL, Feng A, Roberts ZJ, Bach BA. Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone. Ann Surg Oncol. 2015 Sep;22(9):2860-8. doi: 10.1245/s10434-015-4634-9. Epub 2015 Jun 2.

ReferenceCitation: Chawla S, Blay JY, Rutkowski P, Le Cesne A, Reichardt P, Gelderblom H, Grimer RJ, Choy E, Skubitz K, Seeger L, Schuetze SM, Henshaw R, Dai T, Jandial D, Palmerini E. Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. Lancet Oncol. 2019 Dec;20(12):1719-1729. doi: 10.1016/S1470-2045(19)30663-1. Epub 2019 Nov 6.

ReferenceCitation: Engellau J, Seeger L, Grimer R, Henshaw R, Gelderblom H, Choy E, Chawla S, Reichardt P, O'Neal M, Feng A, Jacobs I, Roberts ZJ, Braun A, Bach BA. Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone. World J Surg Oncol. 2018 Sep 19;16(1):191. doi: 10.1186/s12957-018-1478-3.

ReferenceCitation: Bukata SV, Blay JY, Rutkowski P, Skubitz K, Henshaw R, Seeger L, Dai T, Jandial D, Chawla S. Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum. Spine (Phila Pa 1976). 2021 Mar 1;46(5):277-284. doi: 10.1097/BRS.0000000000003728.

ReferenceCitation: Palmerini E, Seeger LL, Gambarotti M, Righi A, Reichardt P, Bukata S, Blay JY, Dai T, Jandial D, Picci P. Malignancy in giant cell tumor of bone: analysis of an open-label phase 2 study of denosumab. BMC Cancer. 2021 Jan 22;21(1):89. doi: 10.1186/s12885-020-07739-8.

ReferenceCitation: Uday S, Gaston CL, Rogers L, Parry M, Joffe J, Pearson J, Sutton D, Grimer R, Hogler W. Osteonecrosis of the Jaw and Rebound Hypercalcemia in Young People Treated With Denosumab for Giant Cell Tumor of Bone. J Clin Endocrinol Metab. 2018 Feb 1;103(2):596-603. doi: 10.1210/jc.2017-02025.

repository_institution: University of Birmingham - University of Birmingham Research Portal

publisher_dissemination: The Endocrine Society

ReferenceCitation: van der Heijden L, van de Sande MA, Hogendoorn PC, Gelderblom H, Dijkstra PD. Neoadjuvant denosumab for extensive giant cell tumor in os ischium: a case report. Acta Orthop. 2015 Jun;86(3):393-5. doi: 10.3109/17453674.2014.1002345. Epub 2015 Feb 14. No abstract available.

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

publisher_dissemination: Medical Journals Sweden AB

title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

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


acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

lead_sponsor: Boehringer Ingelheim

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

location_facility: 1184.15.02057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37252 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3350A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01072 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01070 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01069 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.31051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01065 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.43052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.46053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02060 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01063 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37152 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36053 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49057 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42154 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3351A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01071 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36055 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.37251 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.3352A Boehringer Ingelheim Investigational Site

location_facility: 1184.15.82051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.36054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49056 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01062 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02059 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01052 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.49058 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.45054 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.39051 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.42153 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.01064 Boehringer Ingelheim Investigational Site

location_facility: 1184.15.02058 Boehringer Ingelheim Investigational Site

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

location_country:
Finland
Germany
Italy
Lithuania
Slovakia
Hungary
Denmark
Sweden
Netherlands
Austria
United States
Korea, Republic of
Latvia
South Africa
Canada
Estonia
France

ipd_sharing: Yes