title: Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer

summary: The purpose of this study is to determine [for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients.

ReferenceCitation: Chin BB, Patel P, Cohade C, Ewertz M, Wahl R, Ladenson P. Recombinant human thyrotropin stimulation of fluoro-D-glucose positron emission tomography uptake in well-differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2004 Jan;89(1):91-5. doi: 10.1210/jc.2003-031027.

ReferenceCitation: Pacini F, Ladenson PW, Schlumberger M, Driedger A, Luster M, Kloos RT, Sherman S, Haugen B, Corone C, Molinaro E, Elisei R, Ceccarelli C, Pinchera A, Wahl RL, Leboulleux S, Ricard M, Yoo J, Busaidy NL, Delpassand E, Hanscheid H, Felbinger R, Lassmann M, Reiners C. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study. J Clin Endocrinol Metab. 2006 Mar;91(3):926-32. doi: 10.1210/jc.2005-1651. Epub 2005 Dec 29.

ReferenceCitation: Leboulleux S, Schroeder PR, Busaidy NL, Auperin A, Corone C, Jacene HA, Ewertz ME, Bournaud C, Wahl RL, Sherman SI, Ladenson PW, Schlumberger M. Assessment of the incremental value of recombinant thyrotropin stimulation before 2-[18F]-Fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography imaging to localize residual differentiated thyroid cancer. J Clin Endocrinol Metab. 2009 Apr;94(4):1310-6. doi: 10.1210/jc.2008-1747. Epub 2009 Jan 21.

lead_sponsor: Johns Hopkins University

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Johns Hopkins Division of Endocrinology & Metabolism


title: A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.

status: Completed

study_type: Interventional

primary_purpose: Treatment

lead_sponsor: NYU Langone Health

sponsor_collaborators:
NYU Langone Health
National Cancer Institute (NCI)

location_country:
United States
France

location_facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center

location_facility: Herbert Irving Comprehensive Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: Daiichi Sankyo, Inc.

summary: This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

location_facility: Ege University Medical Faculty - Department of Pediatric Hematology

location_facility: University of Louisville ; Kosair Charities Pediatric Clincial Research Unit

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Istituto Giannina Gaslini - UOSD Emostasi e Trombosi

location_facility: University of California, Los Angeles (UCLA)

location_facility: Lucile Packard Children's Hospital Stanford University

location_facility: Hammoud Hospital University Medical Center

location_facility: University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital

location_facility: St. Jude Children's Research Hospital, Inc.

location_facility: A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova

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

title: A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

primary_purpose: Basic Science

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

design_allocation: Non-Randomized

study_completion_date_type: Actual

location_country:
Italy
India
United Kingdom
Lebanon
United States
Spain
Turkey
Canada
France

ipd_sharing: Yes


title: Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study

summary:
A new coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) appeared in Wuhan, China and it arrived to Europe 2-3 months later. It infected millions of persons and led to the death of thousands until May 2020 where numbers of infections per week decreased significantly. However, starting September, number of infections started to escalate again and continued to rise until now.

Hundreds of good quality articles were published during this period to study the relationship and effects of this virus on pregnancy and vice versa, as well as to determine the adverse neonatal and obstetrical outcomes following the infection. In a case-control study using propensity score matching at the level of age, body mass index and comorbidities (diabetes, hypertension, asthma), pregnant women over 20 week's gestation had significantly higher risk for intensive care unit stay, endotracheal intubation, hospitalization for disease related symptoms and need for oxygen therapy. A new systematic review also demonstrated increased risk for ICU admission in pregnant women compared to non-pregnant women and to non-infected pregnant women.

On the other hand, many researchers have demonstrated that the rates of preterm delivery and cesarean delivery have increased as well, others reported a close relation between SARS-CoV2 infection and preeclampsia or preeclampsia like condition. Enormous effort was done in order to understand adverse outcomes related to this infection, however, most studies included patients in the third or late second trimester. Few studies stratified adverse outcomes of the patients according to the trimester of infection.

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Badr DA, Mattern J, Carlin A, Cordier AG, Maillart E, El Hachem L, El Kenz H, Andronikof M, De Bels D, Damoisel C, Preseau T, Vignes D, Cannie MM, Vauloup-Fellous C, Fils JF, Benachi A, Jani JC, Vivanti AJ. Are clinical outcomes worse for pregnant women at >/=20 weeks' gestation infected with coronavirus disease 2019? A multicenter case-control study with propensity score matching. Am J Obstet Gynecol. 2020 Nov;223(5):764-768. doi: 10.1016/j.ajog.2020.07.045. Epub 2020 Jul 27. No abstract available.

ReferenceCitation: Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320.

ReferenceCitation: Khalil A, von Dadelszen P, Draycott T, Ugwumadu A, O'Brien P, Magee L. Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic. JAMA. 2020 Jul 10;324(7):705-6. doi: 10.1001/jama.2020.12746. Online ahead of print.

ReferenceCitation: Prabhu M, Cagino K, Matthews KC, Friedlander RL, Glynn SM, Kubiak JM, Yang YJ, Zhao Z, Baergen RN, DiPace JI, Razavi AS, Skupski DW, Snyder JR, Singh HK, Kalish RB, Oxford CM, Riley LE. Pregnancy and postpartum outcomes in a universally tested population for SARS-CoV-2 in New York City: a prospective cohort study. BJOG. 2020 Nov;127(12):1548-1556. doi: 10.1111/1471-0528.16403. Epub 2020 Aug 13.

ReferenceCitation: Berghella V, Boelig R, Roman A, Burd J, Anderson K. Decreased incidence of preterm birth during coronavirus disease 2019 pandemic. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100258. doi: 10.1016/j.ajogmf.2020.100258. Epub 2020 Oct 15. No abstract available.

ReferenceCitation: Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.

ReferenceCitation: Cosma S, Carosso AR, Cusato J, Borella F, Carosso M, Bovetti M, Filippini C, D'Avolio A, Ghisetti V, Di Perri G, Benedetto C. Coronavirus disease 2019 and first-trimester spontaneous abortion: a case-control study of 225 pregnant patients. Am J Obstet Gynecol. 2021 Apr;224(4):391.e1-391.e7. doi: 10.1016/j.ajog.2020.10.005. Epub 2020 Oct 8.

ipd_sharing: Undecided

lead_sponsor: Brugmann University Hospital

location_country: Italy Belgium France

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

intervention_type: Other

lead_sponsor_type: academique


title: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)

summary: The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

design_allocation: Randomized

lead_sponsor: United Pharmaceuticals

sponsor_collaborators:
United Pharmaceuticals
Statitec

location_facility:
University of Naples Federico II
Hopital Trousseau
CHR Namur
Hôpital Saint Vincent de Paul - GHICL

intervention_type: Dietary Supplement


summary: The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.

primary_purpose: Health Services Research

ReferenceType: derived

ReferenceCitation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Spain Austria France

location_facility:
CHRU Tours - Hopital Trousseau
Hospital Clinic
Kepler Universitätsklinikum
Hôpital cardiologique du Haut-Lévêque

intervention_type: Device


title: The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

summary: The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

status: Suspended

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Cierra

location_country: Germany Belgium France

location_facility: Cardiovascular Center Frankfurt Sankt katharinen

status_simplified: Unknown


title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

summary: To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

lead_sponsor: Pfizer

location_country:
United States
Italy
France


title: F2-PROTOCOL: Prospective Collection of Data of Possible Prognostic Relevance in Patients With Follicular Lymphoma

summary:
The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI).

The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Federico M, Bellei M, Pro B, Lopez-Guillermo A, Marcheselli L, Trneny M, Soubeyran P, MCLaughlin P, Pileri S, Solal-Céligny P on behalf of the F2 study. Revalidation of FLIPI in patients with Follicular Lymphoma (FL) registered in the F2 study and treated upfront with immunochemotherapy. J Clin Oncol 25(18s), 2007. Abstr 8008.

ReferenceCitation: Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Martelli M, Soubeyran P, Cortelazzo S, Martinelli G, Pileri S, McLaughlin P, Solal-Céligny P on behalf of International Follicular Lymphoma Prognostic factor Project (IFLPFP) F2-study group. F2 prognostic index. Ann Oncol 19(suppl 4):101-102, 2008. Abstr 058.

ReferenceCitation: Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.

ReferenceCitation: Solal-Celigny P, Bellei M, Marcheselli L, Pesce EA, Pileri S, McLaughlin P, Luminari S, Pro B, Montoto S, Ferreri AJ, Deconinck E, Milpied N, Gordon LI, Federico M. Watchful waiting in low-tumor burden follicular lymphoma in the rituximab era: results of an F2-study database. J Clin Oncol. 2012 Nov 1;30(31):3848-53. doi: 10.1200/JCO.2010.33.4474. Epub 2012 Sep 24.

lead_sponsor: Associazione Angela Serra per la ricerca sul cancro

collaborators: The International Non-Hodgkin Lymphoma Prognostic Factor Project

location_country:
Italy
United Kingdom
Argentina
Switzerland
United States
Spain
Czechia
France

location_facility: Policlinico Monteluce - Divisione di Clinica Medica

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica

location_facility: Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II

location_facility: Institu Catala d'Oncologia - Servei d'Hematologia

location_facility: Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia

location_facility: Centre Hospitalier Univeristaire - Hématologie clinique

location_facility: Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica

location_facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Azienda Ospedaliera Sant'Andrea - UOC Ematologia

location_facility: Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia

location_facility: Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia

location_facility: Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia

location_facility: Hopital caremeau - Service de Medecine Interne B

location_facility: Azienda Ospedaliera Universitaria Pisana - UO di Ematologia

location_facility: Institut Bergonié Comprehensive Cancer Center

location_facility: Policlinico Universitario a gestione diretta - Divisione di Ematologia

location_facility: Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology

location_facility: Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica

location_facility: Azienda Ospedaliera S. Carlo - Oncologia Medica

location_facility: Ospedale San Vincenzo - Ematologia e Immunologia

location_facility: Charles University General Hospital - Ist Dept Medicine

location_facility: Centre Hospitalier Universitaire - Hématologie

location_facility: Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico

location_facility: Azienda Ospedaliera Maggiore della Carità

location_facility: Centre Jean Bernard, Clinique Victor Hugo

location_facility: Università la Sapienza, Dip. di Biotecnologie Cellulari ed Ematologia, Sez. Ematologia

location_facility: Hospital Clinic - Institut d'Hematologia i Oncologia

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista


title: European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

acronym: LUMIFOLLOW

summary: The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.

status: Recruiting

ipd_sharing: No

lead_sponsor: iVascular S.L.U.

location_facility: Centre Hospitalier Universitaire Pellegrin

location_facility: Centre Hospitalier Régional Universitaire Morvan de Brest

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV

summary: This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.

status: Active, not recruiting

primary_purpose: Prevention

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Belgium
United States
Thailand
South Africa
Chile
France

location_facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)

location_facility: Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)

location_facility: Universidad San Sebastian - Providencia ( Site 0111)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)

location_facility: Insituut voor tropische Geneeskunde ( Site 0501)

location_facility: Right To Care Research - Esizayo ( Site 0904)

location_facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101

location_facility: North Texas Infectious Diseases Consultants, P.A ( Site 0001)

location_facility: Midway Immunology and Research Center ( Site 0003)

location_facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)

location_facility: Texas Center for Infectious Disease Associates ( Site 0011)

location_facility: Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)

intervention_type: Biological


title: A Phase 2 Study of Pembrolizumab (MK-3475) Every 6 Weeks (Q6W) in Participants With Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

summary: The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W.

location_country:
Italy
Poland
Brazil
United States
South Africa
Turkey
Czechia
Canada
Ukraine
Russian Federation
France

location_facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507)

location_facility: The National Medico-Surgical Center N.I. Pirogov ( Site 0801)

location_facility: Ankara University Department of Hematology, Clinical Research Unit ( Site 1101)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 0509)

location_facility: Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401)

location_facility: CNPE Regional Center of Oncology ( Site 1305)

location_facility: Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)

location_facility: Almazov National Medical Research Centre ( Site 0807)

location_facility: Ege University Medicine of Faculty ( Site 1105)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0803)

location_facility: Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

location_facility: Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902)

location_facility: Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701)


lead_sponsor: Emalex Biosciences Inc.

summary: This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: University Hospitals Cleveland Medical Center

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH

location_facility: Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

location_facility: St. Charles Psychiatric Associates dba Midwest Research Group

location_facility: Helen DeVos Children's Hospital / Spectrum Health Medical Group

location_facility: Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

location_facility: Centrum Bada Klinicznych PI-House Sp. z o.o.

location_facility: Dept. Child Adolescent Psychiatry Uni. Freiburg

location_facility: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

location_facility: Center for Psychiatry and Behavioral Medicine Inc.

location_facility: Northwest Florida Clinical Research Group, LLC

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Pediatric Epilepsy and Neurology Specialists

location_facility: Eastside Therapeutic Resource Inc dba Core Clinical Research

title: Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome

location_country:
Germany
Poland
United States
Canada
France


title: Physiologic Pacing Registry

summary: The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
Poland
India
Hong Kong
Singapore
Australia
Netherlands
Austria
Switzerland
United States
Spain
South Africa
Czechia
Canada
France

location_facility: University of Vermont College of Medicine

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: Hospital Universitario Virgen de la Nieves

location_facility: Asian Institute of Gastroenterology (AIG) Hospital

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca


acronym: PKAN

lead_sponsor: Travere Therapeutics, Inc.

summary: This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.

ReferenceCitation: Klopstock T, Escolar ML, Marshall RD, Perez-Duenas B, Tuller S, Videnovic A, Greblikas F. The FOsmetpantotenate Replacement Therapy (FORT) randomized, double-blind, Placebo-controlled pivotal trial: Study design and development methodology of a novel primary efficacy outcome in patients with pantothenate kinase-associated neurodegeneration. Clin Trials. 2019 Aug;16(4):410-418. doi: 10.1177/1740774519845673. Epub 2019 May 6.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

publisher_dissemination: SAGE Publications

status: Terminated

title: Efficacy, Safety, and Tolerability of Fosmetpantotenate (RE-024), a Phosphopantothenate Replacement Therapy, in Pantothenate Kinase-Associated Neurodegeneration (PKAN) Patients: A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension

location_country:
Germany
Italy
Poland
Norway
United States
Spain
Czechia
Canada
France


title: A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa

acronym: SHARPS

summary: The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

ReferenceCitation: Bechara FG, Podda M, Prens EP, Horvath B, Giamarellos-Bourboulis EJ, Alavi A, Szepietowski JC, Kirby J, Geng Z, Jean C, Jemec GBE, Zouboulis CC. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):1001-1009. doi: 10.1001/jamasurg.2021.3655.

evidence: open (via free pdf)

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: American Medical Association

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Germany
Ireland
Poland
Turkey
Czechia
Canada
France
Colombia
Portugal
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Mexico
Saudi Arabia
Spain
Greece
Russian Federation
Sweden

location_facility: Hospital Santa Creu i Sant Pau /ID# 152742

location_facility: Haukeland University Hospital /ID# 152662

location_facility: Staedtisches Klinikum Dessau /ID# 150876

location_facility: Genl Hospital Andreas Syggros /ID# 150840

location_facility: University of Michigan Hospitals /ID# 200667

location_facility: University General Hospital Attikon /ID# 150841

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069

location_facility: Uludag University Medical Faculty /ID# 150831

location_facility: Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413

location_facility: Genl Hospital Andreas Syggros /ID# 150842

location_facility: Encino Research Center / T. Jo /ID# 171347

location_facility: Spitalul Universitar de Urgenta Elias /ID# 151072

location_facility: University of California Irvine /ID# 170054

location_facility: NewLab Clinical Research Inc. /ID# 151315

location_facility: Penn State Hershey Medical Ctr /ID# 168447

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 150875

location_facility: NW State Med Univ NA Mechnikov /ID# 151197

location_facility: Policlinico Univ Tor Vergata /ID# 150142

location_facility: Hospital General Universitario Gregorio Maranon /ID# 150788

location_facility: Hacettepe University Medical Faculty /ID# 150829

location_facility: Universitaetsklinikum Erlangen /ID# 167251

location_facility: Sjaellands Universitets Hospit /ID# 150795

location_facility: St Vincent's University Hosp /ID# 150043

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 150885

location_facility: Fakult Nem Kralovske Vinohrady /ID# 169173

location_facility: York Dermatology Clinic and Research Centre /ID# 151314

location_facility: King Faisal Specialist Hospital and Research Centre /ID# 153769

location_facility: Radboud Universitair Medisch Centrum /ID# 152157

location_facility: Hospital Univ Germans Trias I Pujol /ID# 150787

location_facility: Universitair Medisch Centrum Groningen /ID# 150662

location_facility: Corporac Sanitaria Parc Tauli /ID# 150789

location_facility: Spitalul Municipal de Urgenta Timisoara /ID# 151073

location_facility: Beth Israel Deaconess Medical Center /ID# 168438


acronym: CREDIBLE - CR

lead_sponsor: Shionogi

summary: This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.

ReferenceCitation: Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18. Erratum In: Clin Pharmacokinet. 2022 Jul;61(7):1069.

publisher_dissemination: Springer-Nature

ReferenceCitation: Naseer S, Weinstein EA, Rubin DB, Suvarna K, Wei X, Higgins K, Goodwin A, Jang SH, Iarikov D, Farley J, Nambiar S. US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja(R)). Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oxford University Press

ReferenceCitation: Bassetti M, Echols R, Matsunaga Y, Ariyasu M, Doi Y, Ferrer R, Lodise TP, Naas T, Niki Y, Paterson DL, Portsmouth S, Torre-Cisneros J, Toyoizumi K, Wunderink RG, Nagata TD. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. Lancet Infect Dis. 2021 Feb;21(2):226-240. doi: 10.1016/S1473-3099(20)30796-9. Epub 2020 Oct 12.

ReferenceCitation: Bassetti M, Ariyasu M, Binkowitz B, Nagata TD, Echols RM, Matsunaga Y, Toyoizumi K, Doi Y. Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study. Infect Drug Resist. 2019 Nov 21;12:3607-3623. doi: 10.2147/IDR.S225553. eCollection 2019.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Udine - Institutional Research Information System

repositories_concat: PubMed Central;air.uniud.it

unpaywall_oa_status: gold

publisher_dissemination: Informa

title: A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

location_country:
Germany
Italy
Guatemala
Israel
United Kingdom
Japan
Brazil
United States
Korea, Republic of
Spain
Thailand
Greece
Croatia
Turkey
Taiwan
France


lead_sponsor: Agios Pharmaceuticals, Inc.

summary: Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.

ReferenceCitation: Grace RF, Rose C, Layton DM, Galacteros F, Barcellini W, Morton DH, van Beers EJ, Yaish H, Ravindranath Y, Kuo KHM, Sheth S, Kwiatkowski JL, Barbier AJ, Bodie S, Silver B, Hua L, Kung C, Hawkins P, Jouvin MH, Bowden C, Glader B. Safety and Efficacy of Mitapivat in Pyruvate Kinase Deficiency. N Engl J Med. 2019 Sep 5;381(10):933-944. doi: 10.1056/NEJMoa1902678.

oa_colors: green other

evidence: open (via free article)

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

location_facility: Wayne State University School of Medicine - Children's Hospital of Michigan

location_facility: New York Presbyterian Hospital- Weil Cornell Medical College

location_facility: UOC Oncoematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Children Hospital of Philadelphia (CHOP)

title: A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency

location_country:
Italy
United Kingdom
Netherlands
United States
Canada
France


title: Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

acronym: SOLSTICE

summary: The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.

ReferenceCitation: Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015.

ReferenceCitation: Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6. doi: 10.2214/AJR.04.1068. No abstract available.

ReferenceCitation: Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051.

ReferenceCitation: Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14. doi: 10.1378/chest.127.6.2007.

ReferenceCitation: Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98. doi: 10.1148/radiol.2351030747.

ReferenceCitation: Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20.

ReferenceCitation: Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.

ReferenceCitation: Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8.

lead_sponsor: Boston Scientific Corporation

location_facility: State University of New York at Stony Brook

location_facility: Cancer Treatment Centers of America at Southeastern Regional Medical Center

location_facility: New York Presbyterian Hospital - Cornell Medical Center


title: Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

summary: A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months

lead_sponsor: Sobi, Inc.

location_country:
Germany
Poland
Hungary
United Kingdom
United States
Turkey
Ukraine
Russian Federation
France

location_facility:
Site 901
Site 107
Site 801
Site 709
Site 101
Site 905
Site 110
Site 902
Site 410
Site 401
Site 503
Site 707
Site 903
Site 403
Site 710
Site 117
Site 704
Site 302
Site 408
Site 116
Site 104
Site 303
Site 907
Site 121
Site 120
Site 402
Site 904
Site 407
Site 705
Site 118
Site 501
Site 504
Site 505
Site 201
Site 701
Site 406
Site 702
Site 202
Site 301
Site 304
Site 802
Site 103
Site 502
Site 114
Site 954
Site 906
Site 106
Site 111
Site 105
Site 706
Site 703
Site 952
Site 112
Site 119
Site 109
Site 102
Site 113
Site 115
Site 108
Site 803
Site 708
Site 405


title: A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies

summary:
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.

ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide.

In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

location_country:
Germany
Israel
United Kingdom
Australia
Belgium
United States
Spain
France

location_facility: University of Texas MD Anderson Cancer Center /ID# 245463

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 252054

location_facility: The Royal Marsden NHS Foundation Trust /ID# 250324

location_facility: Hadassah Medical Center-Hebrew University /ID# 251441

location_facility: Hospital Universitario Ramon y Cajal /ID# 246540

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459

location_facility: Universitair Ziekenhuis Leuven /ID# 246461

location_facility: Hospital Universitario 12 de Octubre /ID# 246538

location_facility: Hospital Clinic de Barcelona /ID# 246543

location_facility: The Chaim Sheba Medical Center /ID# 251442

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062

location_facility: Paratus Clinical Research Woden /ID# 247859

location_facility: Levine Cancer Ins, Carolina Me /ID# 246363

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 245470

location_facility: Mount Sinai Medical Center-Miami Beach /ID# 248251

location_facility: Institut Catala d'Oncologia -Hospital Duran i Reynals /ID# 246537

location_facility: Hospital Universitario Vall d'Hebron /ID# 245475


title: A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma

summary: The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Germany
Hungary
United Kingdom
Australia
United States
China
Korea, Republic of
Spain
Czechia
Canada
Puerto Rico
France

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet

location_facility: Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

location_facility: Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)

location_facility: Floating Hospital for Children at Tufts Medical Center

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)

location_facility: Washington University School of Medicine

location_facility: University of Cincinnati - Vontz Center for Molecular Studies

location_facility: Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont

location_facility: Chonnam National University Hwasun Hospital

location_facility: Tulane University Health Sciences Center

location_facility: St James's University Hospital - Leeds Teaching Hospitals NHS Trust

location_facility: University Hospitals of Derby and Burton NHS Foundation Trust

location_facility: Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc.

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College


title: A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Relapsed or Refractory Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Their Standard Therapy

summary: The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.

ReferenceCitation: Moreau P, Chanan-Khan A, Roberts AW, Agarwal AB, Facon T, Kumar S, Touzeau C, Punnoose EA, Cordero J, Munasinghe W, Jia J, Salem AH, Freise KJ, Leverson JD, Enschede SH, Ross JA, Maciag PC, Verdugo M, Harrison SJ. Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM. Blood. 2017 Nov 30;130(22):2392-2400. doi: 10.1182/blood-2017-06-788323. Epub 2017 Aug 28.

ReferenceCitation: Matulis SM, Gupta VA, Nooka AK, Hollen HV, Kaufman JL, Lonial S, Boise LH. Dexamethasone treatment promotes Bcl-2 dependence in multiple myeloma resulting in sensitivity to venetoclax. Leukemia. 2016 May;30(5):1086-93. doi: 10.1038/leu.2015.350. Epub 2015 Dec 28.

oa_host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

version: acceptedVersion

unpaywall_oa_status: green

sponsor_collaborators:
AbbVie
Genentech, Inc.

location_country:
United States
Australia
France

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 78773

location_facility: University of Michigan Hospitals /ID# 80353

location_facility: University of Arizona Cancer Center - North Campus /ID# 117876

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 77234

location_facility: Northwestern University Feinberg School of Medicine /ID# 117477


title: A Phase 1, Multicentre, Open-label, Dose-escalation Study to Determine a Recommended Clinical Dose (RCD) of DT 9081, Followed by an Expansion Study of DT-9081 at RCD in Participants With Advanced, Recurrent or Metastatic Solid Tumours

acronym: EPRAD

summary: This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended clinical dose (RCD) of DT-9081, followed by an expansion study of DT-9081 at RCD in participants with advanced, recurrent or metastatic solid tumours

lead_sponsor: Domain Therapeutics SA

location_country: Belgium France

location_facility:
Université Catholique de Louvain
Institut Claudius Regaud
Institut Jules Bordet
Institut Curie


title: A Phase 1, Open-Label Study to Assess the Pharmacokinetics, and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

summary:
Primary Objective:

-To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay

Secondary Objective:

-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD

primary_purpose: Other

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Bioverativ, a Sanofi company

location_country:
United States
France

location_facility: Hemophilia Center of Western Pennsylvania_Investigational Site Number :8400001

location_facility: University of Iowa_Investigational Site Number :8400002


title: A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer

summary: The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.

ReferenceCitation: Zeng L, Nikolaev A, Xing C, Della Manna DL, Yang ES. CHK1/2 Inhibitor Prexasertib Suppresses NOTCH Signaling and Enhances Cytotoxicity of Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2020 Jun;19(6):1279-1288. doi: 10.1158/1535-7163.MCT-19-0946. Epub 2020 May 5.

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

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

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Zeng L, Beggs RR, Cooper TS, Weaver AN, Yang ES. Combining Chk1/2 Inhibition with Cetuximab and Radiation Enhances In Vitro and In Vivo Cytotoxicity in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2017 Apr;16(4):591-600. doi: 10.1158/1535-7163.MCT-16-0352. Epub 2017 Jan 30.

lead_sponsor: Eli Lilly and Company

location_facility: University of Alabama at Birmingham Medical Center

location_facility: University of Texas MD Anderson Cancer Center


title: Determinants of the Progression and Outcome of Mitral Regurgitation-PROGRAM STUDY

acronym: PROGRAM

summary: Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. We have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients. The objective of this study is to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.

ReferenceCitation: Magne J, Mahjoub H, Pibarot P, Pirlet C, Pierard LA, Lancellotti P. Prognostic importance of exercise brain natriuretic peptide in asymptomatic degenerative mitral regurgitation. Eur J Heart Fail. 2012 Nov;14(11):1293-302. doi: 10.1093/eurjhf/hfs114. Epub 2012 Jul 10.

ReferenceCitation: Magne J, Mahjoub H, Pierard LA, O'Connor K, Pirlet C, Pibarot P, Lancellotti P. Prognostic importance of brain natriuretic peptide and left ventricular longitudinal function in asymptomatic degenerative mitral regurgitation. Heart. 2012 Apr;98(7):584-91. doi: 10.1136/heartjnl-2011-301128. Epub 2012 Feb 18.

ReferenceCitation: Lancellotti P, Magne J. Stress testing for the evaluation of patients with mitral regurgitation. Curr Opin Cardiol. 2012 Sep;27(5):492-8. doi: 10.1097/HCO.0b013e3283565c3b.

ReferenceCitation: Senechal M, Michaud N, Machaalany J, Bernier M, Dubois M, Magne J, Couture C, Mathieu P, Bertrand OF, Voisine P. Relation of mitral valve morphology and motion to mitral regurgitation severity in patients with mitral valve prolapse. Cardiovasc Ultrasound. 2012 Jan 27;10:3. doi: 10.1186/1476-7120-10-3.

ReferenceCitation: Van de Heyning CM, Magne J, Vrints CJ, Pierard L, Lancellotti P. The role of multi-imaging modality in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2012 Feb;13(2):139-51. doi: 10.1093/ejechocard/jer257. Epub 2011 Nov 29.

ReferenceCitation: Magne J, Lancellotti P, O'Connor K, Van de Heyning CM, Szymanski C, Pierard LA. Prediction of exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. J Am Soc Echocardiogr. 2011 Sep;24(9):1004-12. doi: 10.1016/j.echo.2011.04.003. Epub 2011 May 17.

ReferenceCitation: Magne J, Lancellotti P, Pierard LA. Exercise-induced changes in degenerative mitral regurgitation. J Am Coll Cardiol. 2010 Jul 20;56(4):300-9. doi: 10.1016/j.jacc.2009.12.073.

ReferenceCitation: Magne J, Lancellotti P, Pierard LA. Exercise pulmonary hypertension in asymptomatic degenerative mitral regurgitation. Circulation. 2010 Jul 6;122(1):33-41. doi: 10.1161/CIRCULATIONAHA.110.938241. Epub 2010 Jun 21.

ReferenceCitation: Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.

ReferenceCitation: Mascle S, Schnell F, Thebault C, Corbineau H, Laurent M, Hamonic S, Veillard D, Mabo P, Leguerrier A, Donal E. Predictive value of global longitudinal strain in a surgical population of organic mitral regurgitation. J Am Soc Echocardiogr. 2012 Jul;25(7):766-72. doi: 10.1016/j.echo.2012.04.009. Epub 2012 May 19.

ReferenceCitation: Donal E, Mascle S, Brunet A, Thebault C, Corbineau H, Laurent M, Leguerrier A, Mabo P. Prediction of left ventricular ejection fraction 6 months after surgical correction of organic mitral regurgitation: the value of exercise echocardiography and deformation imaging. Eur Heart J Cardiovasc Imaging. 2012 Nov;13(11):922-30. doi: 10.1093/ehjci/jes068. Epub 2012 Apr 14.

ReferenceCitation: Magne J, Mahjoub H, Dulgheru R, Pibarot P, Pierard LA, Lancellotti P. Left ventricular contractile reserve in asymptomatic primary mitral regurgitation. Eur Heart J. 2014 Jun 21;35(24):1608-16. doi: 10.1093/eurheartj/eht345. Epub 2013 Sep 7.

ReferenceCitation: Toubal O, Mahjoub H, Thebault C, Clavel MA, Dahou A, Magne J, O'Connor K, Beaudoin J, Bernier M, Le Ven F, Pibarot P. Increasing Pulmonary Arterial Pressure at Low Level of Exercise in Asymptomatic, Organic Mitral Regurgitation. J Am Coll Cardiol. 2018 Feb 13;71(6):700-701. doi: 10.1016/j.jacc.2017.11.062. No abstract available.

ReferenceCitation: Clemenceau A, Berube JC, Belanger P, Gaudreault N, Lamontagne M, Toubal O, Clavel MA, Capoulade R, Mathieu P, Pibarot P, Bosse Y. Deleterious variants in DCHS1 are prevalent in sporadic cases of mitral valve prolapse. Mol Genet Genomic Med. 2018 Jan;6(1):114-120. doi: 10.1002/mgg3.347. Epub 2017 Dec 10.

ReferenceCitation: Dupuis M, Mahjoub H, Clavel MA, Cote N, Toubal O, Tastet L, Dumesnil JG, O'Connor K, Dahou A, Thebault C, Belanger C, Beaudoin J, Arsenault M, Bernier M, Pibarot P. Forward Left Ventricular Ejection Fraction: A Simple Risk Marker in Patients With Primary Mitral Regurgitation. J Am Heart Assoc. 2017 Oct 27;6(11):e006309. doi: 10.1161/JAHA.117.006309.

lead_sponsor: Laval University

collaborators: Canadian Institutes of Health Research (CIHR)

location_country: Canada Belgium France

location_facility: University Hospital (CHU) of Brest, Hôpital La Cavale Blanche

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

intervention_type: Genetic


title: A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients

summary: The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

lead_sponsor: Anaconda Pharma

location_country: Argentina France

location_facility: Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology

location_facility: Hopital Henri Mondor-Dept of Dermatology

location_facility: IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.


title: A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)

summary: A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

ReferenceCitation: Kantarjian HM, Sekeres MA, Ribrag V, Rousselot P, Garcia-Manero G, Jabbour EJ, Owen K, Stockman PK, Oliver SD. Phase I study assessing the safety and tolerability of barasertib (AZD1152) with low-dose cytosine arabinoside in elderly patients with AML. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):559-67. doi: 10.1016/j.clml.2013.03.019. Epub 2013 Jun 10.

ReferenceCitation: Quintas-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

lead_sponsor: AstraZeneca


title: An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression

summary: The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.

primary_purpose: Supportive Care

lead_sponsor: Nerviano Medical Sciences

location_facility: The Robert H Lurie Comprehensive Cancer Center, Northwestern University

location_facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille


title: A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma

summary: The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.

lead_sponsor: Bristol-Myers Squibb

location_facility:
Local Institution
Mayo Clinic Arizona


title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

summary: The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

location_facility:
Fox Chase Cancer Center
Local Institution
University Of Alabama At Birmingham


title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

summary: The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

location_country:
Germany
Italy
Portugal
United Kingdom
Hong Kong
Denmark
Australia
Sweden
Austria
Belgium
United States
Spain
Thailand
Malaysia
Canada
France

location_facility: Hospital Universitario Nuestra Senora de Candelaria

location_facility: Indiana University Health La Porte Hospital

location_facility: Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner

location_facility: Chiang Mai Heart Center Medical School Hospital

location_facility: Basildon and Thurrock University Hospitals NHS

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: University of Iowa Hospitals and Clinics

location_facility: Cardiology Associates of Fairfield County

location_facility: Cardiovascular Associates of the Delaware Valley


title: Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp

acronym: SESAME

summary: Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.

ReferenceCitation: See JA, Gebauer K, Wu JK, Manoharan S, Kerrouche N, Sullivan J. High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia. Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.

lead_sponsor: Galderma R&D

sponsor_collaborators:
Galderma R&D
Parexel

location_country:
Italy
United Kingdom
Australia
Netherlands
Switzerland
Spain
France

location_facility:
Italy
Manchester
Bern
See Jo-Ann
Madrid
Alkmaar
France


lead_sponsor: Taiho Oncology, Inc.

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.

ReferenceCitation: Rodon J, Funchain P, Laetsch TW, Arkenau HT, Hervieu A, Singer CF, Murciano-Goroff YR, Chawla SP, Anthony K, Yamamiya I, Liu M, Halim AB, Benhadji KA, Takahashi O, Delaloge S. A phase II study of TAS-117 in patients with advanced solid tumors harboring germline PTEN-inactivating mutations. Future Oncol. 2022 Sep;18(30):3377-3387. doi: 10.2217/fon-2022-0305. Epub 2022 Aug 30.

publisher_dissemination: Future Science Ltd

location_facility: Cleveland Clinic Lerner Research Institute

location_facility: The University of Texas M.D. Anderson Cancer Center

title: A Phase 2 Study of TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations

location_country:
United States
United Kingdom
Austria
France


title: Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck

acronym: ENCHANT

summary: The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

lead_sponsor: Medtronic Cardiovascular

location_country:
Germany
Ireland
Italy
Portugal
Slovakia
United Kingdom
Sweden
Netherlands
Austria
Switzerland
Spain
Greece
Russian Federation
France

location_facility: Corporacío Parc Taulí - Hospital de Sabadell

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: St George's University Hospitals - NHS Trust

location_facility: Ordensklinikum Linz GmbH / Elisabethinen

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré

location_facility: Russian Cardiologic Research and Production Complex, Russian Ministry of Health

location_facility: Universitäts Klinikum Frankfurt - Goethe-Universität

location_facility: Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo


title: A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals With Mild COVID-19

summary:
Research Question: Does convalescent plasma (CCP) collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalisation (for COVID-19) or death in patients with early symptoms of acute COVID-19 who are vulnerable to this disease compared to standard of care?
Study product: Very high antibody titre COVID-19 convalescent plasma collected more than 15 days after end of symptoms in COVID-19 patients who also had received at least one dose of a SARS-CoV-2 vaccine.
Methodology: Multicentre, randomised, open-label, adaptive superiority trial: COVID-19 very high neutralizing Ab titre convalescent plasma vs standard care in 2 cohorts of vulnerable patients (cohort 1: elderly (≥ 70 years) and younger with comorbidities, cohort 2: immunosuppressed patients).
Study phase: Phase 3
Intervention: Two units of high antibody titre COVID-19 convalescent plasma to individuals randomised to the intervention group, 2 units from 2 different donors, preferably transfused on the same day. Plasma provided by convalescent vaccinated donors with a minimum antibody titre of 1:640 against delta variant (B1.617.2) or antibody concentration >=4.000 BAU/ml in the QuantiVac anti-SARS-CoV-2 IgG ELISA or >=20.000 U/ml in the Elecsys anti-SARS-CoV-2 CLIA
Randomisation: 1:1 (standard of care + convalescent plasma vs. standard of care) stratified by centre (cohorts 1 and 2)

lead_sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

location_country:
Germany
United Kingdom
Netherlands
France

location_facility: Institut für Klinische Transfusionsmedizin (IKT)


title: International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70

acronym: MyPeBS

summary:
MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers.

Women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. The main study endpoint will be measured at the end of the four years of intervention.

Furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival

ReferenceCitation: Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Giorgi Rossi P, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Castells X, Ritchie D, Keatley D, Baron C, Delaloge S, de Montgolfier S. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial. BMC Cancer. 2022 May 6;22(1):507. doi: 10.1186/s12885-022-09484-6.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

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

repository_normalized: HAL

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

repository_institution: University of Cambridge - Apollo

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_country:
France
Italy
United Kingdom
Belgium
Spain
Israel

location_facility: Cambridge University Hospitals NHS Foundation Trust


title: A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients With Low-Risk Early Stage Cervical Cancer (SHAPE)

acronym: SHAPE

summary: The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

lead_sponsor: Canadian Cancer Trials Group

collaborators: Arbeitsgemeinschaft Gynaekologische Onkologie Austria

collaborators: Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

collaborators: Institute of Cancer Research, United Kingdom

collaborators: Shanghai Cancer Centre Deptartment of Gynecologic Oncology Fudan University

collaborators: Hertzen Moscow Scientific Research Institute of Oncology

collaborators: Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom Germany

collaborators: Institut Claudius Regaud - Institute Universitaire du Cancer de Toulouse - Oncopole

sponsor_collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
Germany
Ireland
Norway
United Kingdom
Netherlands
Austria
Belgium
China
Canada
Russian Federation
France

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Institut Regional du Cancer de Montpellier

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: Universitaetsklinikum Hamburg - Eppendorf

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Hopital Europeen Georges Pompidou - Paris

location_facility: Klinikum der Universitaet Muenchen - LMU Campus Grosshadern

location_facility: Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Clinical Research Unit at Vancouver Coastal

location_facility: Clinique Mutualiste de la Sagesse - Rennes

intervention_type: Procedure


title: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

summary: The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Colombia
United Kingdom
Argentina
Singapore
Brazil
Austria
Belgium
Lebanon
United States
Mexico
Turkey
Canada
France

location_facility: Azienda Ospedaliera Papa Giovanni XXIII - Unita di Pediatria

location_facility: Groupement Hospitalier Est Hopital, Femme Mère Enfant de Lyon

location_facility: Instytut Pomnik Centrum, Zdrowia Dziecka

location_facility: University of Texas, Health Science Center San Antonio

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Consultario de Joshue David Covarrubias Esquer

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

location_facility: Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Alberta - Women and Children's Health Research Institute


title: A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

summary: This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

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

lead_sponsor: Pfizer

location_country:
Germany
Poland
New Zealand
Japan
Czechia
Canada
Serbia
France
Slovakia
Hungary
United States
Ukraine
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Russian Federation

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital

location_facility: Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium

location_facility: Regional Municipal Non-Profit Enterprise "Chernivtsi Regional Clinical Hospital" Surgery Departm

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Columbia University Medical Center Research Pharmacy/ Milstein Hospital

location_facility: Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology

location_facility: North Shore Hospital (Waitemata District Health Board)

location_facility: Gastro I., s.r.o., Gastroenterologicka ambulancia

location_facility: Military Medical Academy, Clinic for Gastroenterology and Hepatology

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Shiga University of Medical Science Hospital

location_facility: The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School

location_facility: Christchurch Hospital (Canterbury District Health Board)

location_facility: London Health Sciences Centre - University Hospital

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Columbia University Irving Medical Center


title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

summary: The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

ReferenceCitation: Panes J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

repository_institution: University of Michigan - Deep Blue

repositories_concat: PubMed Central;deepblue.lib.umich.edu

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

publisher_dissemination: Wiley

location_country:
Germany
Hungary
Israel
Australia
Japan
Netherlands
Austria
United States
Korea, Republic of
Spain
Greece
South Africa
Czechia
Ukraine
Bulgaria
Canada
France

location_facility: Department of medicine Shaare Zedek Medical Center

location_facility: Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2

location_facility: Shands Hospital at the University of Florida

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Montreal General Hospital-Mcgill University Health Centre

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Office of Drs. Ranjith Andrew Singh, Jamie D. Papp

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: North Florida Gastroenterology Research, LLC

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Medical Clinical Research Center of Medical Center "Health Clinic" LLC

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Gastroenterology Consultants of Clearwater

location_facility: NYU Langone Nassau Gastroenterology Associates


title: A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset

acronym: MACSI

summary: The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

ReferenceCitation: Diener HC, Schneider D, Lampl Y, Bornstein NM, Kozak A, Rosenberg G. DP-b99, a membrane-activated metal ion chelator, as neuroprotective therapy in ischemic stroke. Stroke. 2008 Jun;39(6):1774-8. doi: 10.1161/STROKEAHA.107.506378. Epub 2008 Apr 10.

ReferenceCitation: Rosenberg G, Angel I, Kozak A. Clinical pharmacology of DP-b99 in healthy volunteers: first administration to humans. Br J Clin Pharmacol. 2005 Jul;60(1):7-16. doi: 10.1111/j.1365-2125.2005.02378.x.

ReferenceCitation: Barkalifa R, Hershfinkel M, Friedman JE, Kozak A, Sekler I. The lipophilic zinc chelator DP-b99 prevents zinc induced neuronal death. Eur J Pharmacol. 2009 Sep 15;618(1-3):15-21. doi: 10.1016/j.ejphar.2009.07.019. Epub 2009 Jul 19.

ReferenceCitation: Rosenberg G, Bornstein N, Diener HC, Gorelick PB, Shuaib A, Lees K; MACSI investigators. The Membrane-Activated Chelator Stroke Intervention (MACSI) Trial of DP-b99 in acute ischemic stroke: a randomized, double-blind, placebo-controlled, multinational pivotal phase III study. Int J Stroke. 2011 Aug;6(4):362-7. doi: 10.1111/j.1747-4949.2011.00608.x. Epub 2011 Jun 6.

ReferenceCitation: Rosenberg G, Marshall LS, Caraco Y. The neuroprotective agent DP-b99 does not interact with s-warfarin in vivo despite significant CYP2C9 inhibition in vitro. Basic Clin Pharmacol Toxicol. 2011 Apr;108(4):289-92. doi: 10.1111/j.1742-7843.2010.00654.x. Epub 2010 Dec 16. No abstract available.

lead_sponsor: D-Pharm Ltd.

location_country:
France
Germany
Italy
Poland
Portugal
Slovakia
Hungary
Israel
Brazil
Netherlands
Austria
Switzerland
United States
Korea, Republic of
Spain
South Africa
Canada
Czech Republic

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus

location_facility: Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik

location_facility: Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG

location_facility: Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia

location_facility: Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie

location_facility: Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii

location_facility: Medical University of Lublin, Department of Neurology, Stroke Unit

location_facility: Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft.

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego

location_facility: Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie

location_facility: Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie

location_facility: Klinikum Köln Merheim, Department of Neurology

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Università di Roma "La Sapienza" - Stroke Unit

location_facility: University Hospital Motol Clinic of Neurology

location_facility: Azienda Ospedaliera Sant'Andrea, Stroke Unit

location_facility: Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: Centro de Estudos Egas Moniz - Hospital de Santa Maria

location_facility: Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie

location_facility: Hospitais da Universidadde de Coimbra, EPE

location_facility: Universität Rostock Chefarzt Abteilung Neurologie

location_facility: Hôpital Lariboisière - Service Neurologie

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

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos

location_facility: Capital Health Regional Medical Center Neuroscience Institute

location_facility: Neurology Clinic, Faculty Hospital in Martin

location_facility: The University of Kentucky The Methodist Hospital

location_facility: Memorial Health University Medical Center

location_facility: Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Neurological Dept. Edith Wolfson Medical Center

location_facility: Universitätsspital Zürich, Klinik für Neurologie

location_facility: Marien-Krankenhaus gGmbH, Abteilung für Neurologie

location_facility: Clinic of Neurology, Stroke Center, Charles University

location_facility: Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ

location_facility: Hospital Clinico Universitario de Santiago

location_facility: University Hospital Hradec Kralove, Clinic of Neurology

location_facility: Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie

location_facility: Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia

location_facility: Seoul National University Bundang Hospital

location_facility: Wojskowy Instytut Medyczny, Oddział Neurologii

location_facility: Universitätsklinikum Ulm, Abteilung für Neurologie im RKU

location_facility: Neurologische Universitätsklinik Freiburg, Neurozentrum

location_facility: DRK Kliniken Berlin, Klinik fuer Neurologie

location_facility: Universitätsklinikum Erlangen, Neurologische klinik

location_facility: University of Louisville, Kentucky Neuroscience Research

location_facility: County Hospital Pardubice Clinic of Neurology

location_facility: Georg-August-Universitat Gottingen Neurologische Klinik

location_facility: Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit

location_facility: Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym

location_facility: Dipartimento di Neuroscienze, Ospedale di Brotzu

location_facility: Istituto Scientifico San Raffaele - Stroke Unit

location_facility: Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu

location_facility: Borsod-Abaúj-Zemplén County Hospital Miskolc

location_facility: Medical University of Warsaw, Department of Neurology

location_facility: Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej

location_facility: Hospital Clinico Universitario De Valladolid


title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

summary:
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.

ReferenceCitation: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. doi: 10.1111/j.1365-2133.2012.11156.x.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Finland
Germany
Italy
Hungary
Israel
Denmark
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Royal Infirmary of Edinburgh at Little France

location_facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Allgemeines Krankenhaus - Universitatskliniken


acronym: PTCL

lead_sponsor: Spectrum Pharmaceuticals, Inc

summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

ReferenceCitation: Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23.

oa_host_type: publisher

sponsor_collaborators:
Spectrum Pharmaceuticals, Inc
Valerio Therapeutics

location_facility: Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: Klinika Hematologie a Onkohematologie FNLP a LF UPJS

location_facility: The Christie NHS Foundation Trust, The Christie Hospital,

location_facility: Rambam Medical Center Department of Hematology

location_facility: Erie County Medical Center (Roswell Park)

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii

location_facility: Münchner Studienzentrum Klinikum Rechts der Isar

location_facility: Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica

location_facility: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

location_facility: Universitätsmedizin der johannes Gutenberg -Universität Mainz

location_facility: Leitender Oberarzt/Klinik für Onkologie und Hämatologie

location_facility: University of Tennessee Cancer Institute

location_facility: Tygerberg Hospital, Department of Radiation Oncology

location_facility: St James's Institute of Oncology Bexley Wing

location_facility: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg

location_facility: Klinik Essen Süd, Evangelisches Krankenhaus

location_facility: Belgyógyászati Klinika es Kardiologial Központ

location_facility: Isala Clinics, Department of Haematololgy

location_facility: Hadassah University Hospital Sharet Building Department of Hematology

location_facility: Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland

location_facility: Szpital Wojewódzki w Opolu/Oddział Hematologii

location_facility: Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala

location_facility: The Royal Marsden Haemato-Oncology Wards

location_facility: University of Liege, Divisions of Hematology and Medical Oncology

location_facility: Instytut Hematologii i Transfuzjologii Klinika Hematologii

location_facility: Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital

location_facility: Hospital Clinico Universitario de Santiago

location_facility: VU Medical Center, Department of Haematology

location_facility: Washington University School of Medicine

location_facility: University Medical Center Groningen UMCG, Department of Haematologie

location_facility: Yale Cancer Center-Section of Medical Oncology

location_facility: Groupe Hospitalier Sud Réunion, Site Saint-Pierre

location_facility: Hospital Universitario Central de Asturias

location_facility: Universität Göttingen, Abteilung Hämatologie und Onkologie

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

location_facility: Cliniques Universitaires UCL Mont Godinne, Service Hématologie

location_facility: Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences

location_facility: Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique

location_facility: Clinique Universitaire Saint Luc, Service Hématologie

location_facility: H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241

location_facility: Northern Centre for Cancer Care, Freeman Hospital

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: The UT Health Science Centre at San Antonio

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Pretoria Academic Hospital, Department of Radiation Oncology

location_facility: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Israel
Denmark
United Kingdom
Netherlands
Belgium
United States
Spain
South Africa
Croatia
Canada
Russian Federation
France


title: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

summary: An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, Casanovas M, Subiza JL, Palomares O. MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating Th1, Th17, and IL-10 responses via Syk and MyD88. Mucosal Immunol. 2017 Jul;10(4):924-935. doi: 10.1038/mi.2016.112. Epub 2016 Dec 14.

ReferenceCitation: Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(R). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23.

ReferenceCitation: Lorenzo-Gomez MF, Padilla-Fernandez B, Garcia-Cenador MB, Virseda-Rodriguez AJ, Martin-Garcia I, Sanchez-Escudero A, Vicente-Arroyo MJ, Miron-Canelo JA. Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015.

publisher_dissemination: Frontiers

ReferenceCitation: Ramirez Sevilla C, Gomez Lanza E, Manzanera JL, Martin JAR, Sanz MAB. Active immunoprophyilaxis with uromune(R) decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects. BMC Infect Dis. 2019 Oct 28;19(1):901. doi: 10.1186/s12879-019-4541-y.

lead_sponsor: Impatients N.V. trading as myTomorrows

sponsor_collaborators:
Impatients N.V. trading as myTomorrows
Inmunotek S.L.

location_country: Finland Germany Slovenia Slovakia Norway Denmark Romania Sweden Netherlands Belgium Luxembourg Turkey Czechia Serbia France

location_facility:
Finland
Germany
Slovenia
Slovakia
Norway
Denmark
Romania
Sweden
Belgium
Luxembourg
Turkey
Serbia
Czech Republic
The Netherlands
France