title: A Simple Approach to Estimate Alveolar Recruitability in Patients With Acute Respiratory Distress Syndrome: a Validation Study

summary: This study will test the validity of a new approach to assess alveolar recruitability at the bedside in comparison to direct measurements of lung volume and derecruitment.

ReferenceCitation: Chen L, Brochard L. Lung volume assessment in acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Jun;21(3):259-64. doi: 10.1097/MCC.0000000000000193. Review.

ReferenceCitation: Ashbaugh DG, Bigelow DB, Petty TL, Levine BE. Acute respiratory distress in adults. Lancet. 1967 Aug 12;2(7511):319-23.

ReferenceCitation: Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86.

ReferenceCitation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801.

ReferenceCitation: Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

ReferenceCitation: Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

name: Keenan Research Centre and Li Ka Shing Institute, Department of Critical Care, St. Michael’s Hospital, Toronto, Ontario, Canada

name: Interdepartmental Division of Critical Care Medicine, and

name: Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada

family: Chen

full_name: Lu Chen

given: Lu

name: Division of Respirology and Critical Care Medicine, Toronto General Hospital, Toronto, Ontario, Canada

family: Del Sorbo

full_name: Lorenzo Del Sorbo

given: Lorenzo

name: Istituto di Anestesia e Rianimazione, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

family: Grieco

full_name: Domenico L. Grieco

given: Domenico L.

name: Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, and

family: Junhasavasdikul

full_name: Detajin Junhasavasdikul

given: Detajin

name: Division of Respiratory Diseases and Tuberculosis, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

family: Rittayamai

full_name: Nuttapol Rittayamai

given: Nuttapol

name: Critical Care Department, King Saud Medical City, Riyadh, Saudi Arabia

family: Soliman

full_name: Ibrahim Soliman

given: Ibrahim

family: Sklar

full_name: Michael C. Sklar

given: Michael C.

name: Anestesia e Rianimazione, Ospedali Riuniti di Foggia, Foggia, Italy; and

family: Rauseo

full_name: Michela Rauseo

given: Michela

family: Ferguson

full_name: Niall D. Ferguson

given: Niall D.

family: Fan

full_name: Eddy Fan

given: Eddy

name: Emergency Department, General Hospital of Annecy, Annecy, France

family: Richard

full_name: Jean-Christophe M. Richard

given: Jean-Christophe M.

family: Brochard

full_name: Laurent Brochard

given: Laurent

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

lead_sponsor: Unity Health Toronto

location_country: Canada France China

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Centre Hospitalier Universitaire - CHU Angers


title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-BX: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy

acronym: ADAPT

summary: The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: GE Healthcare

location_country:
United States
France

location_facility: Cooper Health - Cooper Breast Imaging Centers

location_facility: Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Grant/Funding Number

title: Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

summary: CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.

ReferenceType: derived

ReferenceCitation: Léotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pépin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.

family: Léotard

full_name: Antoine Léotard

given: Antoine

sequence: first

family: Lesgoirres

full_name: Matthieu Lesgoirres

given: Matthieu

sequence: additional

family: Daabek

full_name: Najeh Daabek

given: Najeh

family: Lebret

full_name: Marius Lebret

given: Marius

family: Bailly

full_name: Sebastien Bailly

given: Sebastien

family: Verain

full_name: Alain Verain

given: Alain

family: Series

full_name: Fréderic Series

given: Fréderic

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Sleep and Breathing

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Laval University

location_country: Canada France

location_facility: IUCPQ AGIRADOM CHUM

lead_sponsor_type: academique


title: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers

summary: The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

status: Completed

primary_purpose: Basic Science

lead_sponsor: Mondelēz International, Inc.

location_country: Canada Australia France

location_facility: Human Nutrition Unit, The University of Sydney

intervention_type: Other

status_simplified: Completed


title: Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

acronym: CBCT-ENT

summary: The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

study_start_date_type: Actual

ipd_sharing: No

lead_sponsor: Carestream Health, Inc.

location_country:
United States
Belgium
France

location_facility:
Johns Hopkins Medical Center
C.H.U Bicetre
Sint-Augustinus Hospital

intervention_type: Radiation


title: A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

summary: Exploratory, international, multi-centre, randomized, investigator blinded study in acne

lead_sponsor: Galderma R&D

intervention_type: Drug


type: Other Identifier

title: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

summary: This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.

lead_sponsor: Genentech, Inc.

location_facility: Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo


title: Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens

summary: The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: Aaren Scientific Inc.

location_facility:
Stephenson Eye Associates
Eyesight Ophthalmic Services
Cabinet d'Ophtalmologie du Dr. Pey


title: An Open-Label, Dose-Escalation, Phase IB II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination With Oral Everolimus in Subjects With Solid Tumors

acronym: Cancer

summary: The purpose of this study is to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 dosed in combination with everolimus in subjects with solid tumors. The escalation part of the study will determine the MTD. The combination will be further explored in the expansion part in subjects with metastatic pancreatic cancer. In addition, subjects with KRAS mutant non-small cell lung cancer will be enrolled.

design_allocation: Non-Randomized

ReferenceCitation: Tolcher AW, Bendell JC, Papadopoulos KP, Burris HA 3rd, Patnaik A, Jones SF, Rasco D, Cox DS, Durante M, Bellew KM, Park J, Le NT, Infante JR. A phase IB trial of the oral MEK inhibitor trametinib (GSK1120212) in combination with everolimus in patients with advanced solid tumors. Ann Oncol. 2015 Jan;26(1):58-64. doi: 10.1093/annonc/mdu482. Epub 2014 Oct 24.

family: Tolcher

full_name: A.W. Tolcher

family: Bendell

full_name: J.C. Bendell

family: Papadopoulos

full_name: K.P. Papadopoulos

family: Burris

full_name: H.A. Burris

suffix: III

family: Patnaik

full_name: A. Patnaik

given: A.

family: Jones

full_name: S.F. Jones

family: Rasco

full_name: D. Rasco

given: D.

family: Cox

full_name: D.S. Cox

family: Durante

full_name: M. Durante

given: M.

family: Bellew

full_name: K.M. Bellew

family: Park

full_name: J. Park

given: J.

family: Le

full_name: N.T. Le

family: Infante

full_name: J.R. Infante

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: GlaxoSmithKline


title: A PhaseI/II, Open Label Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF

summary: This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.

primary_purpose: Other

lead_sponsor: AstraZeneca


title: A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin

summary: The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

time_perspective: Prospective

ReferenceCitation: Bytzer P, Pratt S, Elkin E, Næsdal J, Sörstadius E. Burden of upper gastrointestinal symptoms in patients receiving low-dose acetylsalicylic acid for cardiovascular risk management: a prospective observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):27-35. doi: 10.1007/s40256-012-0001-4.

family: Bytzer

full_name: Peter Bytzer

given: Peter

family: Pratt

full_name: Stephen Pratt

given: Stephen

family: Elkin

full_name: Eric Elkin

given: Eric

family: Næsdal

full_name: Jørgen Næsdal

given: Jørgen

family: Sörstadius

full_name: Elisabeth Sörstadius

given: Elisabeth

journal_name: American Journal of Cardiovascular Drugs

publisher_dissemination: Springer

publisher_group: Springer

title: Burden of Upper Gastrointestinal Symptoms in Patients Receiving Low-Dose Acetylsalicylic Acid for Cardiovascular Risk Management

ReferenceCitation: Pratt S, Thompson VJ, Elkin EP, Næsdal J, Sörstadius E. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs. 2010;10(5):281-8. doi: 10.2165/11584410-000000000-00000.

family: Thompson

full_name: Vincent J. Thompson

given: Vincent J.

full_name: Eric P. Elkin

given: Eric P.

journal_name: American Journal Cardiovascular Drugs

title: The Impact of Upper Gastrointestinal Symptoms on Nonadherence to, and Discontinuation of, Low-Dose Acetylsalicylic Acid in Patients with Cardiovascular Risk

location_country:
United States
Canada
France


title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis

summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.

ReferenceCitation: Sermet-Gaudelus I, Boeck KD, Casimir GJ, Vermeulen F, Leal T, Mogenet A, Roussel D, Fritsch J, Hanssens L, Hirawat S, Miller NL, Constantine S, Reha A, Ajayi T, Elfring GL, Miller LL. Ataluren (PTC124) induces cystic fibrosis transmembrane conductance regulator protein expression and activity in children with nonsense mutation cystic fibrosis. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1262-72. doi: 10.1164/rccm.201001-0137OC. Epub 2010 Jul 9.

family: Sermet-Gaudelus

full_name: Isabelle Sermet-Gaudelus

given: Isabelle

family: Boeck

full_name: Kris De Boeck

given: Kris De

family: Casimir

full_name: Georges J. Casimir

given: Georges J.

family: Vermeulen

full_name: François Vermeulen

given: François

family: Leal

full_name: Teresinha Leal

given: Teresinha

family: Mogenet

full_name: Agnès Mogenet

given: Agnès

family: Roussel

full_name: Delphine Roussel

given: Delphine

family: Fritsch

full_name: Janine Fritsch

given: Janine

family: Hanssens

full_name: Laurence Hanssens

given: Laurence

family: Hirawat

full_name: Samit Hirawat

given: Samit

family: Miller

full_name: Nilsen L. Miller

given: Nilsen L.

family: Constantine

full_name: Scott Constantine

given: Scott

family: Reha

full_name: Allen Reha

given: Allen

family: Ajayi

full_name: Temitayo Ajayi

given: Temitayo

family: Elfring

full_name: Gary L. Elfring

given: Gary L.

full_name: Langdon L. Miller

given: Langdon L.

title: Ataluren (PTC124) Induces Cystic Fibrosis Transmembrane Conductance Regulator Protein Expression and Activity in Children with Nonsense Mutation Cystic Fibrosis

lead_sponsor: PTC Therapeutics

location_country: Belgium France

location_facility:
UZ Gasthuisberg Leuven
Hopital Necker Enfants Malades
Reine Fabiola Hospital


title: A Multicenter, Open-label, Single-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum- and Erlotinib-resistant Locally Advanced or Metastatic Non-small-cell Lung Adenocarcinoma

summary:
This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).

Primary objective:

To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA.

Secondary objective:

To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population
To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®).

This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation.

In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.

ReferenceType: result

ReferenceCitation: Leighl NB, Raez LE, Besse B, Rosen PJ, Barlesi F, Massarelli E, Gabrail N, Hart LL, Albain KS, Berkowitz L, Melnyk O, Shepherd FA, Sternas L, Ackerman J, Shun Z, Miller VA, Herbst RS. A multicenter, phase 2 study of vascular endothelial growth factor trap (Aflibercept) in platinum- and erlotinib-resistant adenocarcinoma of the lung. J Thorac Oncol. 2010 Jul;5(7):1054-9.

lead_sponsor: Sanofi


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.

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. 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.

name: Department of Nuclear Medicine and Endocrine Oncology (S.L., C.C., C.B., M.S.), Institut Gustave Roussy, University Paris Sud-XI, 94805 Villejuif, France

family: Leboulleux

full_name: S. Leboulleux

given: S.

name: Department of Medicine (P.R.S., M.E.E., P.W.L.), Division of Endocrinology and Metabolism, Johns Hopkins University School of Medicine, Baltimore, Maryland 21201

family: Schroeder

full_name: P. R. Schroeder

given: P. R.

name: Department of Endocrine Neoplasia and Hormonal Disorders (N.L.B., S.I.S.), Unit 435, Department of Endocrine Neoplasia and Hormonal Disorders, The M. D. Anderson Cancer Center, Houston, Texas 77030

family: Busaidy

full_name: N. L. Busaidy

given: N. L.

name: Department of Statistics (A.A.), Institut Gustave Roussy, 94800 Villejuif, France

family: Auperin

full_name: A. Auperin

given: A.

family: Corone

full_name: C. Corone

given: C.

name: Russell H. Morgan Department of Radiology and Radiological Science (H.A.J., R.L.W.), Division of Nuclear Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287

family: Jacene

full_name: H. A. Jacene

given: H. A.

family: Ewertz

full_name: M. E. Ewertz

given: M. E.

family: Bournaud

full_name: C. Bournaud

family: Wahl

full_name: R. L. Wahl

given: R. L.

family: Sherman

full_name: S. I. Sherman

given: S. I.

family: Ladenson

full_name: P. W. Ladenson

given: P. W.

family: Schlumberger

full_name: M. Schlumberger

given: M.

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via free pdf)

license_normalized: no license

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: 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

lead_sponsor: Johns Hopkins University

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.

lead_sponsor: NYU Langone Health

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

location_facility: Herbert Irving Comprehensive Cancer Center


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/

lead_sponsor: Daiichi Sankyo, Inc.

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

location_facility: Ege University Medical Faculty - Department of Pediatric Hematology

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

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

location_facility: Lucile Packard Children's Hospital Stanford University

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

location_facility: Istituto Giannina Gaslini - UOSD Emostasi e Trombosi

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

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

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Hammoud Hospital University Medical Center

location_facility: University of California, Los Angeles (UCLA)

ipd_sharing: Yes

type: EudraCT Number

source: euctr

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

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.


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.

time_perspective: Retrospective

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.

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. doi: 10.1001/jama.2020.12746. [Epub 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.

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


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.

lead_sponsor: United Pharmaceuticals

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

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

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.

family: Chinitz

full_name: Larry Chinitz

given: Larry

family: Ritter

full_name: Philippe Ritter

given: Philippe

family: Khelae

full_name: Surinder Kaur Khelae

given: Surinder Kaur

family: Iacopino

full_name: Saverio Iacopino

given: Saverio

family: Garweg

full_name: Christophe Garweg

given: Christophe

family: Grazia-Bongiorni

full_name: Maria Grazia-Bongiorni

given: Maria

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Johansen

full_name: Jens Brock Johansen

given: Jens Brock

family: Mont

full_name: Lluis Mont

given: Lluis

family: Gonzalez

full_name: Efrain Gonzalez

given: Efrain

family: Sagi

full_name: Venkata Sagi

given: Venkata

family: Duray

full_name: Gabor Z. Duray

given: Gabor Z.

family: Clementy

full_name: Nicolas Clementy

given: Nicolas

family: Sheldon

full_name: Todd Sheldon

given: Todd

family: Splett

full_name: Vincent Splett

given: Vincent

family: Stromberg

full_name: Kurt Stromberg

given: Kurt

family: Wood

full_name: Nicole Wood

given: Nicole

family: Steinwender

full_name: Clemens Steinwender

given: Clemens

journal_name: Heart Rhythm

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Austria France Spain

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


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

lead_sponsor: Cierra

location_country: Germany Belgium France

location_facility: Cardiovascular Center Frankfurt Sankt katharinen


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:
Italy
United States
France


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

lead_sponsor: iVascular S.L.U.

location_facility: Centre Hospitalier Universitaire Pellegrin

location_facility: Centre Hospitalier Régional Universitaire Morvan de Brest

status_simplified: Ongoing


lead_sponsor: Taiho Oncology, Inc.

location_country:
Austria
United States
United Kingdom
France

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

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.


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

primary_purpose: Supportive Care

lead_sponsor: Dova Pharmaceuticals

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

location_facility: Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology,and Immunology

location_facility: State Budget Health Institution of Moscow-Morozov Children's City Clinical Hospital


title: A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome

summary: This study is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

lead_sponsor: Emalex Biosciences Inc.

location_country:
Italy
United States
France
Poland
Hungary
Germany
Canada

location_facility: Northwest Florida Clinical Research Group, LLC

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

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

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

location_facility: Ospedaliera Universitaria Policlinico Umberto I

location_facility: Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

location_facility: Center for Psychiatry and Behavioral Medicine Inc.

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: St. Charles Psychiatric Associates dba Midwest Research Group

location_facility: Dept. Child Adolescent Psychiatry Uni. Freiburg

location_facility: University Hospitals Cleveland Medical Center

location_facility: Pediatric Epilepsy and Neurology Specialists

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH

location_facility: Eastside Therapeutic Resource Inc dba Core Clinical Research

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Azienda Ospedaliera Vittorio Emanuele Policlinico

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

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

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


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

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_country:
United States
France
Poland
Germany
Canada

location_facility: Northwest Florida Clinical Research Group, LLC

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

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


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.

status: Active, not recruiting

lead_sponsor: Abbott Medical Devices

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

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

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

location_facility: Asian Institute of Gastroenterology (AIG) Hospital

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: Hospital Universitario Virgen de la Nieves

location_facility: University of Vermont College of Medicine


ReferenceCitation: Klopstock T, Escolar ML, Marshall RD, Perez-Dueñas 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.

name: Department of Neurology, Friedrich-Baur-Institute, Ludwig-Maximilians-University of Munich, Munich, Germany

name: German Center for Neurodegenerative Diseases (DZNE), Munich, Germany

name: Munich Cluster for Systems Neurology (SyNergy), Munich, Germany

family: Klopstock

full_name: Thomas Klopstock

given: Thomas

name: Department of Pediatrics, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

family: Escolar

full_name: Maria L Escolar

given: Maria L

name: Formerly of Research & Development, Retrophin, Inc., San Diego, CA, USA

family: Marshall

full_name: Randall D Marshall

given: Randall D

name: Department of Child Neurology, Hospital Universitari Vall d’Hebron, Barcelona, Spain

family: Perez-Dueñas

full_name: Belen Perez-Dueñas

given: Belen

family: Tuller

full_name: Sarah Tuller

given: Sarah

name: Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

family: Videnovic

full_name: Aleksandar Videnovic

given: Aleksandar

family: Greblikas

full_name: Feriandas Greblikas

given: Feriandas

journal_name: Clinical Trials

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Travere Therapeutics, Inc.

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

acronym: PKAN

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

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


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, Horváth 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.

name: Department of Dermatology, Venereology, and Allergology, St Josef Hospital, Ruhr-University Bochum, Bochum, Germany

family: Bechara

full_name: Falk G. Bechara

given: Falk G.

name: Department of Dermatology, Medical Center Klinikum Darmstadt, Teaching Hospital Goethe-University Frankfurt, Darmstadt, Germany

family: Podda

full_name: Maurizio Podda

given: Maurizio

name: Department of Dermatology, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Prens

full_name: Errol P. Prens

given: Errol P.

name: Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

family: Horváth

full_name: Barbara Horváth

given: Barbara

name: 4th Department of Internal Medicine, National and Kapodistrian University of Athens Medical School, Athens, Greece

family: Giamarellos-Bourboulis

full_name: Evangelos J. Giamarellos-Bourboulis

given: Evangelos J.

name: Division of Dermatology, Women’s College Hospital, University of Toronto, Toronto, Ontario, Canada

family: Alavi

full_name: Afsaneh Alavi

given: Afsaneh

name: Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland

family: Szepietowski

full_name: Jacek C. Szepietowski

given: Jacek C.

name: Department of Dermatology, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania

family: Kirby

full_name: Joslyn Kirby

given: Joslyn

family: Geng

full_name: Ziqian Geng

given: Ziqian

family: Jean

full_name: Christine Jean

given: Christine

name: Department of Dermatology, Zealand University Hospital, Roskilde, Denmark

family: Jemec

full_name: Gregor B. E. Jemec

given: Gregor B. E.

name: Department of Dermatology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany

name: Department of Venereology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany

name: Department of Allergology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany

name: Department of Immunology, Dessau Medical Center, Brandenburg Medical School Theodor Fontane, Dessau, Germany

family: Zouboulis

full_name: Christos C. Zouboulis

given: Christos C.

journal_name: JAMA Surgery

oa_colors: green other

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

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

location_facility: Universitair Medisch Centrum Groningen /ID# 150662

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

location_facility: Spitalul Universitar de Urgenta Elias /ID# 151072

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

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

location_facility: Fakult Nem Kralovske Vinohrady /ID# 169173

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

location_facility: Penn State Hershey Medical Ctr /ID# 168447

location_facility: Sjaellands Universitets Hospit /ID# 150795

location_facility: Spitalul Municipal de Urgenta Timisoara /ID# 151073

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

location_facility: Universitaetsklinikum Erlangen /ID# 167251

location_facility: Genl Hospital Andreas Syggros /ID# 150842

location_facility: Policlinico Univ Tor Vergata /ID# 150142

location_facility: Hospital General Universitario Gregorio Maranon /ID# 150788

location_facility: Uludag University Medical Faculty /ID# 150831

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

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

location_facility: University General Hospital Attikon /ID# 150841

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

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

location_facility: Beth Israel Deaconess Medical Center /ID# 168438

location_facility: Genl Hospital Andreas Syggros /ID# 150840

location_facility: Staedtisches Klinikum Dessau /ID# 150876

location_facility: University of California Irvine /ID# 170054

location_facility: Hacettepe University Medical Faculty /ID# 150829

location_facility: NewLab Clinical Research Inc. /ID# 151315

location_facility: Corporac Sanitaria Parc Tauli /ID# 150789

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

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 150875

location_facility: Radboud Universitair Medisch Centrum /ID# 152157

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

location_facility: University of Michigan Hospitals /ID# 200667

location_facility: Haukeland University Hospital /ID# 152662


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®). Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799.

name: Division of Anti-Infectives, Office of Infectious Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA

family: Naseer

full_name: Shabnam Naseer

given: Shabnam

family: Weinstein

full_name: Edward A Weinstein

given: Edward A

name: Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA

family: Rubin

full_name: Daniel B Rubin

given: Daniel B

family: Suvarna

full_name: Kalavati Suvarna

given: Kalavati

name: Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA

family: Wei

full_name: Xiaohui Wei

given: Xiaohui

family: Higgins

full_name: Karen Higgins

given: Karen

family: Goodwin

full_name: Avery Goodwin

given: Avery

family: Jang

full_name: Seong H Jang

given: Seong H

family: Iarikov

full_name: Dmitri Iarikov

given: Dmitri

family: Farley

full_name: John Farley

given: John

family: Nambiar

full_name: Sumathi Nambiar

given: Sumathi

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: 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.

family: Bassetti

full_name: Matteo Bassetti

given: Matteo

family: Echols

full_name: Roger Echols

given: Roger

family: Matsunaga

full_name: Yuko Matsunaga

given: Yuko

family: Ariyasu

full_name: Mari Ariyasu

given: Mari

family: Doi

full_name: Yohei Doi

given: Yohei

family: Ferrer

full_name: Ricard Ferrer

given: Ricard

family: Lodise

full_name: Thomas P Lodise

given: Thomas P

family: Naas

full_name: Thierry Naas

given: Thierry

family: Niki

full_name: Yoshihito Niki

given: Yoshihito

family: Paterson

full_name: David L Paterson

given: David L

family: Portsmouth

full_name: Simon Portsmouth

given: Simon

family: Torre-Cisneros

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.

repository_institution: University of Udine - Institutional Research Information System

title: 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

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

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

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.


title: A Randomized, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects With Psoriatic Arthritis.

summary: To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.

ReferenceCitation: Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.

family: Coates

full_name: Laura C. Coates

given: Laura C.

family: Gottlieb

full_name: Alice B. Gottlieb

given: Alice B.

family: Merola

full_name: Joseph F. Merola

given: Joseph F.

family: Boone

full_name: Caroline Boone

given: Caroline

family: Szumski

full_name: Annette Szumski

given: Annette

family: Chhabra

full_name: Amit Chhabra

given: Amit

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.

name: Dermatology Centre; Manchester Academic Health Science Centre; Salford Royal Hospital; University of Manchester; M6 8HD Manchester U.K

family: Griffiths

full_name: C.E.M. Griffiths

family: Christophers

full_name: E. Christophers

given: E.

name: Specialty Care; Pfizer Inc; Collegeville PA U.S.A

full_name: A. Szumski

given: A.

family: Jones

full_name: H. Jones

given: H.

family: Mallbris

full_name: L. Mallbris

given: L.

journal_name: British Journal of Dermatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.

ReferenceCitation: Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.

name: Dermatology Centre; Salford Royal NHS Foundation Trust; Manchester Academic Health Science Centre; University of Manchester; Manchester M6 8HD U.K

name: Charité Universitätsmedizin; Charitéplatz 1 10117 Berlin Germany

family: Sterry

full_name: W. Sterry

given: W.

name: Quanticate; Bancroft Court Hitchin Hertfordshire SG5 1LH U.K

family: Brock

full_name: F. Brock

given: F.

name: Pfizer; Ramsgate Road Sandwich Kent CT13 9NJ U.K

family: Dilleen

full_name: M. Dilleen

given: M.

name: Pfizer Inc; 113, v. Valbondione 00188 Rome Italy

family: Stefanidis

full_name: D. Stefanidis

given: D.

name: Pfizer Specialty Care; Medical Affairs Europe; 23-25 avenue du Docteur Lannelongue 75668 Paris France

family: Germain

full_name: J.M. Germain

name: Pfizer; 500 Arcola Road Collegeville PA 19426 U.S.A

ReferenceCitation: Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.

journal_name: Journal of the European Academy of Dermatology and Venereology

ReferenceCitation: Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Greece
Australia
Belgium
Denmark
Czech Republic
Taiwan
France
Poland
Argentina
Korea, Republic of
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Serbia
Mexico
Spain
Turkey


title: A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

summary: The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

ReferenceCitation: Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2.

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Koenig

full_name: Andrew S. Koenig

given: Andrew S.

full_name: Heather Jones

given: Heather

journal_name: Seminars in Arthritis and Rheumatism

ReferenceCitation: Braun J, Pavelka K, Ramos-Remus C, Dimic A, Vlahos B, Freundlich B, Koenig AS. Clinical efficacy of etanercept versus sulfasalazine in ankylosing spondylitis subjects with peripheral joint involvement. J Rheumatol. 2012 Apr;39(4):836-40. doi: 10.3899/jrheum.110885. Epub 2012 Feb 15.

family: BRAUN

full_name: JÜRGEN BRAUN

given: JÜRGEN

family: PAVELKA

full_name: KAREL PAVELKA

given: KAREL

family: RAMOS-REMUS

full_name: CESAR RAMOS-REMUS

given: CESAR

family: DIMIC

full_name: ALEKSANDAR DIMIC

given: ALEKSANDAR

family: VLAHOS

full_name: BONNIE VLAHOS

given: BONNIE

family: FREUNDLICH

full_name: BRUCE FREUNDLICH

given: BRUCE

family: KOENIG

full_name: ANDREW S. KOENIG

given: ANDREW S.

title: Clinical Efficacy of Etanercept Versus Sulfasalazine in Ankylosing Spondylitis Subjects with Peripheral Joint Involvement

ReferenceCitation: Braun J, van der Horst-Bruinsma IE, Huang F, Burgos-Vargas R, Vlahos B, Koenig AS, Freundlich B. Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. Arthritis Rheum. 2011 Jun;63(6):1543-51. doi: 10.1002/art.30223.

family: Braun

full_name: Juergen Braun

given: Juergen

family: van der Horst-Bruinsma

full_name: Irene E. van der Horst-Bruinsma

given: Irene E.

family: Huang

full_name: Feng Huang

given: Feng

family: Burgos-Vargas

full_name: Ruben Burgos-Vargas

given: Ruben

family: Vlahos

full_name: Bonnie Vlahos

given: Bonnie

family: Freundlich

full_name: Bruce Freundlich

given: Bruce

title: Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: A randomized, double-blind trial

location_country:
Italy
Austria
Sweden
Saudi Arabia
United Kingdom
Netherlands
Spain
Finland
France
Poland
Hungary
Australia
Ireland
China
Denmark
Germany
Czech Republic
Qatar


title: A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: KarMMa

summary: This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

ReferenceCitation: Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

ReferenceCitation: Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.

ReferenceCitation: Da Vià MC, Dietrich O, Truger M, Arampatzi P, Duell J, Heidemeier A, Zhou X, Danhof S, Kraus S, Chatterjee M, Meggendorfer M, Twardziok S, Goebeler ME, Topp MS, Hudecek M, Prommersberger S, Hege K, Kaiser S, Fuhr V, Weinhold N, Rosenwald A, Erhard F, Haferlach C, Einsele H, Kortüm KM, Saliba AE, Rasche L. Homozygous BCMA gene deletion in response to anti-BCMA CAR T cells in a patient with multiple myeloma. Nat Med. 2021 Apr;27(4):616-619. doi: 10.1038/s41591-021-01245-5. Epub 2021 Feb 22.

family: Da Vià

full_name: Matteo C. Da Vià

given: Matteo C.

family: Dietrich

full_name: Oliver Dietrich

given: Oliver

family: Truger

full_name: Marietta Truger

given: Marietta

family: Arampatzi

full_name: Panagiota Arampatzi

given: Panagiota

family: Duell

full_name: Johannes Duell

given: Johannes

family: Heidemeier

full_name: Anke Heidemeier

given: Anke

family: Zhou

full_name: Xiang Zhou

given: Xiang

family: Danhof

full_name: Sophia Danhof

given: Sophia

family: Kraus

full_name: Sabrina Kraus

given: Sabrina

family: Chatterjee

full_name: Manik Chatterjee

given: Manik

family: Meggendorfer

full_name: Manja Meggendorfer

given: Manja

family: Twardziok

full_name: Sven Twardziok

given: Sven

family: Goebeler

full_name: Maria-Elisabeth Goebeler

given: Maria-Elisabeth

family: Topp

full_name: Max S. Topp

given: Max S.

family: Hudecek

full_name: Michael Hudecek

given: Michael

family: Prommersberger

full_name: Sabrina Prommersberger

family: Hege

full_name: Kristen Hege

given: Kristen

family: Kaiser

full_name: Shari Kaiser

given: Shari

family: Fuhr

full_name: Viktoria Fuhr

given: Viktoria

family: Weinhold

full_name: Niels Weinhold

given: Niels

family: Rosenwald

full_name: Andreas Rosenwald

given: Andreas

family: Erhard

full_name: Florian Erhard

given: Florian

location_country:
Italy
United States
Germany
France
Japan
Belgium
Spain
Canada

location_facility: Centre Hospitalier Regional Universitaire de Lille-Hopital Calude Huriez Service des Maladies du Sang

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: University of California - San Francisco

location_facility: Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato

location_facility: Tokyo Women's Medical University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes - Hotel Dieu

location_facility: University of Texas Southwestern Medical Center


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.

family: Matulis

full_name: S M Matulis

given: S M

family: Gupta

full_name: V A Gupta

given: V A

family: Nooka

full_name: A K Nooka

given: A K

family: Hollen

full_name: H V Hollen

given: H V

family: Kaufman

full_name: J L Kaufman

given: J L

family: Lonial

full_name: S Lonial

given: S

family: Boise

full_name: L H Boise

given: L H

journal_name: Leukemia

oa_host_type: repository

license: implied-oa

license_normalized: implied-oa

version: acceptedVersion

location_country:
United States
Australia
France

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

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

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

location_facility: University of Michigan Hospitals /ID# 80353

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


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.

family: See

full_name: Jo-Ann See

given: Jo-Ann

family: Gebauer

full_name: Kurt Gebauer

given: Kurt

family: Wu

full_name: Jason K. Wu

given: Jason K.

family: Manoharan

full_name: Shobhan Manoharan

given: Shobhan

family: Kerrouche

full_name: Nabil Kerrouche

given: Nabil

family: Sullivan

full_name: John Sullivan

given: John

journal_name: Dermatology and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

lead_sponsor: Galderma R&D

location_country:
Italy
Switzerland
Netherlands
France
Australia
Spain
United Kingdom

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


title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

summary:
This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.

lead_sponsor: Seagen Inc.

location_country:
Switzerland
France
Spain
United States
United Kingdom

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: MD Anderson Cancer Center / University of Texas


title: A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

acronym: fAMHOPE

summary: This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

primary_purpose: Prevention

lead_sponsor: Erasme University Hospital

location_country: Belgium France

location_facility:
CUB-Hôpital Erasme
CHRU Lille
CHC-Saint Vincent
Centre Oscar Lambret


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.

family: Zeng

full_name: Ling Zeng

given: Ling

family: Nikolaev

full_name: Anatoly Nikolaev

given: Anatoly

family: Xing

full_name: Chuan Xing

given: Chuan

family: Della Manna

full_name: Deborah L. Della Manna

given: Deborah L.

family: Yang

full_name: Eddy S. Yang

given: Eddy S.

journal_name: Molecular Cancer Therapeutics

publisher: American Association for Cancer Research (AACR)

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.

family: Beggs

full_name: Reena R. Beggs

given: Reena R.

family: Cooper

full_name: Tiffiny S. Cooper

given: Tiffiny S.

family: Weaver

full_name: Alice N. Weaver

given: Alice N.

lead_sponsor: Eli Lilly and Company

location_country:
United States
France

location_facility: University of Alabama at Birmingham Medical Center

location_facility: University of Texas MD Anderson Cancer Center


title: A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

summary:
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer.

This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.

Patients who sign up for this trial must also fall into one of these categories:

Patients have already received treatment with platinum-containing chemotherapy
Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

ReferenceCitation: Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12. Erratum in: Lancet Oncol. 2021 Jun;22(6):e239.

family: Yu

full_name: Evan Y Yu

given: Evan Y

family: Petrylak

full_name: Daniel P Petrylak

given: Daniel P

family: O'Donnell

full_name: Peter H O'Donnell

given: Peter H

family: Lee

full_name: Jae-Lyun Lee

given: Jae-Lyun

family: van der Heijden

full_name: Michiel S van der Heijden

given: Michiel S

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Stein

full_name: Mark N Stein

given: Mark N

family: Necchi

full_name: Andrea Necchi

given: Andrea

family: Kojima

full_name: Takahiro Kojima

given: Takahiro

family: Harrison

full_name: Michael R Harrison

given: Michael R

family: Hoon Park

full_name: Se Hoon Park

given: Se

family: Quinn

full_name: David I Quinn

given: David I

family: Heath

full_name: Elisabeth I Heath

given: Elisabeth I

family: Rosenberg

full_name: Jonathan E Rosenberg

given: Jonathan E

family: Steinberg

full_name: Joyce Steinberg

given: Joyce

family: Liang

full_name: Shang-Ying Liang

given: Shang-Ying

family: Trowbridge

full_name: Janet Trowbridge

given: Janet

family: Campbell

full_name: Mary Campbell

given: Mary

family: McGregor

full_name: Bradley McGregor

given: Bradley

family: Balar

full_name: Arjun V Balar

given: Arjun V

journal_name: The Lancet Oncology

title: Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial

ReferenceCitation: Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29.

name: Memorial Sloan Kettering Cancer Center, New York, NY

name: Weill Cornell Medical College, New York, NY

full_name: Jonathan E. Rosenberg

given: Jonathan E.

name: New York University Langone Health, New York, NY

name: Dana-Farber Cancer Institute, Boston, MA

name: Fred Hutchinson Cancer Research Center, Seattle, WA

name: Icahn School of Medicine at Mount Sinai, New York, NY

name: Johns Hopkins University School of Medicine, Baltimore, MD

publisher: American Society of Clinical Oncology (ASCO)

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
United States
Netherlands
France
Japan
Spain
Germany
Korea, Republic of

location_facility: Greenville Health System Cancer Institute

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Washington University School of Medicine

location_facility: Hillman Cancer Center / University of Pittsburgh Medical Center

location_facility: James Cancer Hospital / Ohio State University

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Chao Family Comprehensive Cancer Center University of California Irvine

location_facility: New York University (NYU) Cancer Institute

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: University of California Irvine - Newport

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Keck Medical Center / University of Southern California


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.

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

family: Sekeres

full_name: Mikkael A. Sekeres

given: Mikkael A.

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Jabbour

full_name: Elias J. Jabbour

given: Elias J.

family: Owen

full_name: Kate Owen

given: Kate

family: Stockman

full_name: Paul K. Stockman

given: Paul K.

family: Oliver

full_name: Stuart D. Oliver

given: Stuart D.

journal_name: Clinical Lymphoma Myeloma and Leukemia

title: Phase I Study Assessing the Safety and Tolerability of Barasertib (AZD1152) With Low-Dose Cytosine Arabinoside in Elderly Patients With AML

ReferenceCitation: Quintás-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.

name: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

family: Quintás-Cardama

full_name: Alfonso Quintás-Cardama

given: Alfonso

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

family: Liu-Dumlao

full_name: Theresa Liu-Dumlao

given: Theresa

family: Brandt

full_name: Mark Brandt

given: Mark

family: Faderl

full_name: Stefan Faderl

given: Stefan

family: Pierce

full_name: Sherry Pierce

given: Sherry

family: Borthakur

full_name: Gautam Borthakur

given: Gautam

family: Cortes

full_name: Jorge Cortes

given: Jorge


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.

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:
Mayo Clinic Arizona
Local Institution


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


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

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

location_facility: Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

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

location_facility: St George's University Hospitals - NHS Trust

location_facility: CHU de Bordeaux - Centre Universitaire Pellegrin

location_facility: Universitäts Klinikum Frankfurt - Goethe-Universität

location_facility: Corporacío Parc Taulí - Hospital de Sabadell

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

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Ordensklinikum Linz GmbH / Elisabethinen


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.

status: Enrolling by invitation

lead_sponsor: Mirum Pharmaceuticals, Inc.

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

location_facility: University of Texas, Health Science Center San Antonio

location_facility: Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

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

location_facility: Instytut Pomnik Centrum, Zdrowia Dziecka

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Alberta, Edmonton Clinic Health Academy

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

location_facility: Consultario de Joshue David Covarrubias Esquer


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.

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

location_facility: Christchurch Hospital (Canterbury District Health Board)

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

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans,

location_facility: North Shore Hospital (Waitemata District Health Board)

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

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Shiga University of Medical Science Hospital

location_facility: Ustavni lekarna Nemocnice Strakonice, a.s.

location_facility: Clinical Applications Laboratories, Inc.

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

location_facility: Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak

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

location_facility: Osaka Medical and Pharmaceutical University Hospital

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

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

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

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

location_facility: Military Medical Academy, Clinic for Gastroenterology and Hepatology

location_facility: CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

location_facility: Columbia University Medical Center Research Pharmacy/ Milstein Hospital

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

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium

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

location_facility: Christus Trinity Mother Frances Endoscopy Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: Columbia University Irving Medical Center

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Clinical Research Institute of Michigan, LLC


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: Panés 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.

name: Inflammatory Bowel Diseases Unit; Hospital Clínic de Barcelona, IDIBAPS, CIBERehd; Barcelona Spain

family: Panés

full_name: Julián Panés

given: Julián

name: Department of Gastroenterology; Academic Medical Centre; Amsterdam The Netherlands

family: D’Haens

full_name: Geert R. D’Haens

given: Geert R.

name: Department of Internal Medicine; University of Michigan; Ann Arbor Michigan

family: Higgins

full_name: Peter D. R. Higgins

given: Peter D. R.

name: Inflammation & Immunology; Pfizer Inc; Collegeville Pennsylvania

family: Mele

full_name: Linda Mele

given: Linda

family: Moscariello

full_name: Michele Moscariello

given: Michele

family: Chan

full_name: Gary Chan

given: Gary

family: Wang

full_name: Wenjin Wang

given: Wenjin

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

family: Su

full_name: Chinyu Su

given: Chinyu

family: Maller

full_name: Eric Maller

given: Eric

journal_name: Alimentary Pharmacology & Therapeutics

repository_institution: University of Michigan - Deep Blue

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

title: 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

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

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

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

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Department of medicine Shaare Zedek Medical Center

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

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: Montreal General Hospital-Mcgill University Health Centre

location_facility: National Hospital Organization Sendai Medical Center

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

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

location_facility: Gastroenterology Consultants of Clearwater

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

location_facility: The Hospital of Hyogo College of Medicine

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

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

location_facility: Shands Hospital at the University of Florida

location_facility: North Florida Gastroenterology Research, LLC

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

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

location_facility: Gastroenterology Associates of Central Georgia, LLC

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


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

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:
Italy
France
Israel
Belgium
Spain
United Kingdom

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

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

location_facility: Institut Regional du Cancer de Montpellier

location_facility: East Kent Hospitals University NHS Foundation Trust

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

location_facility: Universitaetsklinikum Hamburg - Eppendorf

location_facility: Clinical Research Unit at Vancouver Coastal

location_facility: Hopital Europeen Georges Pompidou - Paris

location_facility: Klinikum der Universitaet Muenchen - LMU Campus Grosshadern

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Clinique Mutualiste de la Sagesse - Rennes

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Kaiserswerther Diakonie - Florence-Nightingale-Krankenhaus

intervention_type: Procedure