ReferenceCitation: Baumann A, Piel I, Hucke F, Sandmann S, Hetzel T, Schwarz T. Pharmacokinetics, excretion, distribution, and metabolism of 60-kDa polyethylene glycol used in BAY 94-9027 in rats and its value for human prediction. Eur J Pharm Sci. 2019 Mar 15;130:11-20. doi: 10.1016/j.ejps.2019.01.015. Epub 2019 Jan 14.

ReferenceCitation: Lalezari S, Reding MT, Pabinger I, Holme PA, Negrier C, Chalasani P, Shin HJ, Wang M, Tseneklidou-Stoeter D, Maas Enriquez M. BAY 94-9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results. Haemophilia. 2019 Nov;25(6):1011-1019. doi: 10.1111/hae.13853. Epub 2019 Oct 17.

ReferenceCitation: Reding MT, Ng HJ, Poulsen LH, Eyster ME, Pabinger I, Shin HJ, Walsch R, Lederman M, Wang M, Hardtke M, Michaels LA. Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017 Mar;15(3):411-419. doi: 10.1111/jth.13597. Epub 2017 Feb 22.

intervention_type: Biological

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Japan
Poland
Israel
Norway
Romania
Belgium
Singapore
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan
Colombia

acronym: PROTECT-VIII

title: A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

summary:
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.

The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.

In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.

120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.

Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.


type: EudraCT Number

title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

summary: The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.

family: Dunayevich

full_name: Eduardo Dunayevich

given: Eduardo

sequence: first

family: Buchanan

full_name: Robert W Buchanan

given: Robert W

sequence: additional

family: Chen

full_name: Chao-Yin Chen

given: Chao-Yin

family: Yang

full_name: Jun Yang

given: Jun

family: Nilsen

full_name: Jon Nilsen

given: Jon

family: Dietrich

full_name: Julie M Dietrich

given: Julie M

family: Sun

full_name: Hong Sun

given: Hong

family: Marder

full_name: Stephen Marder

given: Stephen

bso_classification: Social sciences

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Schizophrenia Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Amgen

location_country:
United Kingdom
France
Malaysia
Poland
United States
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

summary: This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

status: Completed

ipd_sharing: Yes

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
United States
United Kingdom
France

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Tufts University School of Medicine-Tufts Medical Center

location_facility: Vanderbilt University, Vanderbilt Ingram Cancer Center

location_facility: UT Southwestern Medical Center, Simmons Cancer Center

location_facility: Universitaria Policlinico S. Orsola Malpighi, Institute of Hemtology "L. & A. Seragnoli"

location_facility: Medical University of South Carolina, Hollings Cancer Center

status_simplified: Completed


title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

acronym: FEATURE

summary: The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

study_start_date_type: Actual

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

family: Houghton

full_name: Katherine Houghton

given: Katherine

family: Patil

full_name: Dhaval Patil

given: Dhaval

family: Gomez

full_name: Braulio Gomez

given: Braulio

family: Feldman

full_name: Steven R. Feldman

given: Steven R.

bso_classification: Medical research

journal_name: Dermatology and Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. Epub 2016 Aug 30.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
France
Estonia
Germany
Canada


title: Patient Retrospective Outcomes (PRO)

acronym: PRO

summary: This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Australia
Puerto Rico
Spain
Germany
United Kingdom

location_facility: West Florida Orthopedics and Spine Surgery

location_facility: Pres. Osp. Civile Santi Antonio e Biagio

location_facility: Advanced Diagnostic Pain Treatment Centers

location_facility: Western Reserve Spine and Pain Institute

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Twin Cities Pain Clinic & Surgery Center

location_facility: Multidisciplinary Pain Management Services

location_facility: Womens Health and Research Institute of Australia

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Willis-Knighton River Cities Clinical Research Center

location_facility: UCSD Medical Center - Jacobs Medical Center

location_facility: Advanced Interventional Pain Management and Research Clinic, Inc.

location_facility: Interventional Pain Specialists of Wisconsin

location_facility: Basildon and Thurrock University Hospitals NHS

location_facility: Vidant Roanoke - Chowan Hospital Pain Center

location_facility: Integrative Pain and Wellness Associates

intervention_type: Device

status_simplified: Ongoing


title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

summary:
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

ReferenceCitation: van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6. Erratum in: Lancet Neurol. 2018 Jan;17 (1):26. Erratum in: Lancet Neurol. 2018 Aug;17(8):661.

family: van Schaik

full_name: Ivo N van Schaik

given: Ivo N

family: Bril

full_name: Vera Bril

given: Vera

family: van Geloven

full_name: Nan van Geloven

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Lewis

full_name: Richard A Lewis

given: Richard A

family: Sobue

full_name: Gen Sobue

given: Gen

family: Lawo

full_name: John-Philip Lawo

given: John-Philip

family: Praus

full_name: Michaela Praus

given: Michaela

family: Mielke

full_name: Orell Mielke

given: Orell

family: Durn

full_name: Billie L Durn

given: Billie L

family: Cornblath

full_name: David R Cornblath

given: David R

family: Merkies

full_name: Ingemar S J Merkies

given: Ingemar S J

family: Sabet

full_name: A. Sabet

given: A.

family: George

full_name: K. George

given: K.

family: Roberts

full_name: L. Roberts

given: L.

family: Carne

full_name: R. Carne

given: R.

family: Blum

full_name: S. Blum

given: S.

family: Henderson

full_name: R. Henderson

family: Van Damme

full_name: P. Van Damme

given: P.

family: Demeestere

full_name: J. Demeestere

given: J.

family: Larue

full_name: S. Larue

family: D'Amour

full_name: C. D'Amour

given: C.

full_name: V. Bril

given: V.

family: Breiner

full_name: A. Breiner

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

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

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

location_country:
Italy
United States
Netherlands
Germany
Finland
France
Czechia
Japan
Israel
Poland
Belgium
Australia
Spain
Estonia
Canada
United Kingdom

location_facility:
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ReferenceCitation: Tönshoff B, Tedesco-Silva H, Ettenger R, Christian M, Bjerre A, Dello Strologo L, Marks SD, Pape L, Veldandi U, Lopez P, Cousin M, Pandey P, Meier M. Three-year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal. Am J Transplant. 2021 Jan;21(1):123-137. doi: 10.1111/ajt.16005. Epub 2020 Jun 27.

name: Department of Pediatrics I University Children's Hospital Heidelberg Heidelberg Germany

family: Tönshoff

full_name: Burkhard Tönshoff

given: Burkhard

name: Nephrology Division Hospital do RimUNIFESP São Paulo Brazil

family: Tedesco‐Silva

full_name: Helio Tedesco‐Silva

given: Helio

name: Division of Pediatric Nephrology UCLA Mattel Children's Hospital Los Angeles California USA

family: Ettenger

full_name: Robert Ettenger

given: Robert

name: Department of Pediatric Nephrology Nottingham Children's Hospital Nottingham UK

family: Christian

full_name: Martin Christian

given: Martin

name: Division of Pediatric and Adolescent Medicine Department of Pediatrics Oslo University Hospital Oslo Norway

family: Bjerre

full_name: Anna Bjerre

given: Anna

name: Nephrology Unit Department of Pediatrics Institute for Scientific ResearchBambino Gesù Children's Hospital Rome Italy

family: Dello Strologo

full_name: Luca Dello Strologo

given: Luca

name: Department of Pediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health, NIHR Great Ormond Street Hospital Biomedical Research Centre London UK

family: Marks

full_name: Stephen D. Marks

given: Stephen D.

name: Department of Pediatric Nephrology Hannover Medical School Hannover Germany

family: Pape

full_name: Lars Pape

given: Lars

name: Novartis Healthcare Pvt. Ltd. Hyderabad India

family: Veldandi

full_name: Udaykiran Veldandi

given: Udaykiran

family: Lopez

full_name: Patricia Lopez

given: Patricia

family: Cousin

full_name: Marc Cousin

given: Marc

family: Pandey

full_name: Priti Pandey

given: Priti

family: Meier

full_name: Matthias Meier

given: Matthias

journal_name: American Journal of Transplantation

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Three‐year outcomes from the CRADLE study in de novo pediatric kidney transplant recipients receiving everolimus with reduced tacrolimus and early steroid withdrawal

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

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

location_country:
Italy
Brazil
Sweden
Germany
France
Poland
Norway
Hungary
Argentina
Spain
Turkey
United States
United Kingdom

acronym: not applicable

ipd_sharing: Undecided

source: euctr

title: A 12-month, Multicenter, Open Label, Randomized, Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced CNI, and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients With a 24-month Additional Safety Follow-up.

summary:
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function.

This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.


title: A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease

summary: This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

lead_sponsor: GlaxoSmithKline

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Turkey
Chile
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Estonia


type: Registry Identifier

type: Other Identifier

type: U.S. NIH Grant/Contract

title: A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

summary: This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

lead_sponsor: Gynecologic Oncology Group

location_country:
Netherlands
France
Venezuela
Norway
Belgium
Spain
United States
United Kingdom

location_facility: Saint James Community Hospital and Cancer Treatment Center

location_facility: Toledo Community Hospital Oncology Program CCOP

location_facility: Christiana Care Health System-Wilmington Hospital

location_facility: Memorial Health University Medical Center

location_facility: Missouri Baptist Outpatient Center-Sunset Hills

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: Lake Norman Hematology Oncology Specialists-Mooresville

location_facility: California Pacific Medical Center-Pacific Campus

location_facility: Saint Patrick Hospital - Community Hospital

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: University of Oklahoma Health Sciences Center

location_facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

location_facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center

location_facility: Greenville Health System Cancer Institute-Easley

location_facility: Cooper Hospital University Medical Center

location_facility: Franciscan Research Center-Northwest Medical Plaza

location_facility: Southwest Gynecologic Oncology Associates Inc

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: Dayton Physicians LLC-Miami Valley South

location_facility: Toledo Clinic Cancer Centers-Bowling Green

location_facility: Florida Hospital Cancer Institute Altamonte

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: UC Comprehensive Cancer Center at Silver Cross

location_facility: Alta Bates Summit Medical Center-Herrick Campus

location_facility: Wilcox Memorial Hospital and Kauai Medical Clinic

location_facility: UPMC Uniontown Hospital Radiation Oncology

location_facility: Southern Illinois University School of Medicine

location_facility: Saint Luke's Mountain States Tumor Institute - Meridian

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Armstrong Center for Medicine and Health

location_facility: Anchorage Associates in Radiation Medicine

location_facility: UH Seidman Cancer Center at Landerbrook Health Center

location_facility: Rockwood Clinic Cancer Treatment Center-Valley

location_facility: University of Iowa/Holden Comprehensive Cancer Center

location_facility: Delaware Health Center-Grady Cancer Center

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Cancer Center of Kansas-Wichita Medical Arts Tower

location_facility: Saint Luke's Mountain States Tumor Institute - Fruitland

location_facility: Palo Alto Medical Foundation Health Care

location_facility: UPMC Washington Hospital Radiation Oncology

location_facility: Providence Regional Cancer System-Shelton

location_facility: Virginia Mason Federal Way Medical Center

location_facility: Delaware Clinical and Laboratory Physicians PA

location_facility: Iowa-Wide Oncology Research Coalition NCORP

location_facility: Tacoma/Valley Radiation Oncology Centers-Puyallup

location_facility: Presbyterian - Saint Lukes Medical Center - Health One

location_facility: Wichita NCI Community Oncology Research Program

location_facility: Novant Health Presbyterian Medical Center

location_facility: Lake Norman Hematology Oncology Specialists-Huntersville

location_facility: Franciscan Saint Anthony Health-Michigan City

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: Kaiser Permanente-Deer Valley Medical Center

location_facility: Washington University School of Medicine

location_facility: Florida Hospital Cancer Institute Winter Park

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: Geisinger Medical Center-Cancer Center Hazleton

location_facility: Sudarshan K Sharma MD Limited-Gynecologic Oncology

location_facility: Memorial Regional Cancer Center Day Road

location_facility: University of Cincinnati/Barrett Cancer Center

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: UPMC-Johnstown/John P. Murtha Regional Cancer Center

location_facility: McFarland Clinic PC-Trinity Cancer Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Saint Joe's

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: Tacoma/Valley Radiation Oncology Centers-Jackson Hall

location_facility: Dayton Physician LLC-Miami Valley Hospital North

location_facility: Wayne State University/Karmanos Cancer Institute

location_facility: Palo Alto Medical Foundation-Camino Division

location_facility: Harrison HealthPartners Hematology and Oncology-Bremerton

location_facility: Providence Regional Cancer System-Aberdeen

location_facility: UPMC Cancer Centers - Arnold Palmer Pavilion

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Saint Louis Cancer and Breast Institute-South City

location_facility: Columbus Oncology and Hematology Associates Inc

location_facility: Saint Luke's Mountain States Tumor Institute-Twin Falls

location_facility: Cone Health Cancer Center at Alamance Regional

location_facility: Greenville Health System Cancer Institute-Spartanburg

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: Saint Luke's Mountain States Tumor Institute

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: Kansas Institute of Medicine Cancer and Blood Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Kansas City NCI Community Oncology Research Program

location_facility: Walter Reed National Military Medical Center

location_facility: Greenville Health System Cancer Institute-Faris

location_facility: Genesis Healthcare System Cancer Care Center

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: UPMC-Coraopolis/Heritage Valley Radiation Oncology

location_facility: UH Seidman Cancer Center at Lake Health Mentor Campus

location_facility: University of Maryland/Greenebaum Cancer Center

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: Kaiser Permanente Medical Center-Vacaville

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Providence Saint Mary Regional Cancer Center

location_facility: Memorial Sloan Kettering Rockville Centre

location_facility: Palo Alto Medical Foundation-Gynecologic Oncology

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Novant Health Cancer Specialists-Matthews

location_facility: Virginia Mason Bainbridge Island Medical Center

location_facility: Atrium Medical Center-Middletown Regional Hospital

location_facility: Olive View-University of California Los Angeles Medical Center

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: CHI Saint Vincent Cancer Center Hot Springs

location_facility: Columbus NCI Community Oncology Research Program

location_facility: Dayton NCI Community Oncology Research Program

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Providence Willamette Falls Medical Center

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Providence Regional Cancer System-Centralia

location_facility: UPMC-Heritage Valley Health System Beaver

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: Providence Oncology and Hematology Care Southeast

location_facility: Northeast Georgia Medical Center-Gainesville

location_facility: Greenville Health System Cancer Institute-Greer

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Maine Medical Center- Scarborough Campus

location_facility: Sainte Genevieve County Memorial Hospital

location_facility: University of Mississippi Medical Center

location_facility: Comprehensive Cancer Care and Research Institute of Colorado LLC

location_facility: Zuckerberg San Francisco General Hospital

location_facility: Central Illinois Hematology Oncology Center

location_facility: Harrison HealthPartners Hematology and Oncology-Poulsbo

location_facility: Summa Akron City Hospital/Cooper Cancer Center

location_facility: Saint Vincent Hospital and Health Care Center

location_facility: State University of New York Upstate Medical University

location_facility: Greenville Health System Cancer Institute-Seneca

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: The Toledo Hospital/Toledo Children's Hospital

location_facility: Rockwood Cancer Treatment Center-DHEC-Downtown

location_facility: Tacoma/Valley Radiation Oncology Centers-Gig Harbor

location_facility: Pulmonary Medicine Center of Chattanooga-Hixson

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: Medical Oncology and Hematology Associates-Laurel

location_facility: Mercy Clinic-Rolla-Cancer and Hematology

location_facility: Northwest NCI Community Oncology Research Program

location_facility: Saint Joseph Radiation Oncology Resource Center

location_facility: Greenville Health System Cancer Institute-Butternut

location_facility: Medical Oncology Hematology Consultants PA

location_facility: Jewish Hospital Medical Center Northeast

location_facility: Rocky Mountain Cancer Centers-Greenwood Village

location_facility: UPMC Jefferson Regional Radiation Oncology

location_facility: Greenville Health System Cancer Institute-Eastside

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Saint Luke's Mountain States Tumor Institute - Nampa

location_facility: Swedish Cancer Institute-Eastside Oncology Hematology

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Cancer Care Specialists of Illinois-Swansea

location_facility: Heartland Hematology and Oncology Associates Incorporated

location_facility: University Hospitals Sharon Health Center

location_facility: Western Illinois Cancer Treatment Center

location_facility: MD Anderson Cancer Center at Cooper-Voorhees

location_facility: New York-Presbyterian/Brooklyn Methodist Hospital

intervention_type: Other


title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
United Kingdom
France
Israel
Argentina
Spain
Germany
Latvia


title: A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

summary:
Primary Objective:

- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

To assess the effect of the 2 lixisenatide regimens on:

The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
Fasting Plasma Glucose (FPG)
7-point Self-Monitored Plasma Glucose (SMPG) profiles
Body weight
To assess the safety and tolerability of the 2 lixisenatide regimens

ReferenceType: result

ReferenceCitation: Ahrén B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

family: Ahrén

full_name: Bo Ahrén

given: Bo

family: Vorokhobina

full_name: Natalia Vorokhobina

given: Natalia

family: Souhami

full_name: Elisabeth Souhami

given: Elisabeth

family: Demil

full_name: Nacima Demil

given: Nacima

family: Ye

full_name: Jenny Ye

given: Jenny

family: Aronson

full_name: Ronnie Aronson

given: Ronnie

journal_name: Journal of Diabetes and its Complications

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

lead_sponsor: Sanofi

location_country:
United States
France
Poland
Romania
Russian Federation
Spain
Germany
Czech Republic
Canada
Ukraine

location_facility:
Investigational Site Number 124111
Investigational Site Number 724108
Investigational Site Number 616108
Investigational Site Number 124105
Investigational Site Number 840118
Investigational Site Number 250108
Investigational Site Number 804108
Investigational Site Number 804104
Investigational Site Number 724102
Investigational Site Number 840112
Investigational Site Number 616104
Investigational Site Number 840111
Investigational Site Number 804102
Investigational Site Number 124104
Investigational Site Number 276103
Investigational Site Number 840103
Investigational Site Number 276102
Investigational Site Number 643105
Investigational Site Number 724103
Investigational Site Number 724105
Investigational Site Number 804105
Investigational Site Number 276108
Investigational Site Number 724106
Investigational Site Number 616103
Investigational Site Number 840113
Investigational Site Number 124112
Investigational Site Number 250103
Investigational Site Number 642103
Investigational Site Number 840107
Investigational Site Number 124106
Investigational Site Number 203102
Investigational Site Number 643101
Investigational Site Number 276104
Investigational Site Number 804101
Investigational Site Number 124113
Investigational Site Number 643108
Investigational Site Number 840115
Investigational Site Number 840110
Investigational Site Number 840120
Investigational Site Number 250102
Investigational Site Number 642101
Investigational Site Number 724104
Investigational Site Number 840119
Investigational Site Number 804106
Investigational Site Number 643106
Investigational Site Number 840105
Investigational Site Number 643110
Investigational Site Number 643103
Investigational Site Number 250105
Investigational Site Number 616101
Investigational Site Number 276105
Investigational Site Number 840104
Investigational Site Number 276101
Investigational Site Number 616105
Investigational Site Number 642102
Investigational Site Number 840101
Investigational Site Number 124108
Investigational Site Number 203104
Investigational Site Number 124102
Investigational Site Number 616106
Investigational Site Number 616107
Investigational Site Number 643102
Investigational Site Number 643107
Investigational Site Number 642105
Investigational Site Number 724107
Investigational Site Number 203105
Investigational Site Number 276107
Investigational Site Number 203106
Investigational Site Number 724101
Investigational Site Number 840114
Investigational Site Number 124101
Investigational Site Number 124110
Investigational Site Number 642104
Investigational Site Number 203101
Investigational Site Number 124103
Investigational Site Number 840102
Investigational Site Number 203103
Investigational Site Number 616102
Investigational Site Number 643104
Investigational Site Number 804103
Investigational Site Number 840116
Investigational Site Number 840122


title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK221149A Administered Intravenously and to Investigate the Pharmacokinetics of GSK221149A Administered Orally to Healthy, Pregnant Females With Uncomplicated Pre-term Labor Between 300/7 and 356/7 Weeks' Gestation

summary: Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.

ReferenceType: background

ReferenceCitation: Jerry Snidow, Hugh Miller, Guillermo Valenzuela, Steve Thornton, Brendt Stier, Linda Clayton, Michael Fossler, Timothy Montague, Kathleen Beach, Pauline Williams. A Multicenter, Randomized, Double-blind Placebo-controlled Phase II Trial of Retosiban, a Selective Oxytocin Receptor Antagonist, for the Management of Preterm Labor. Am J Obstet Gynecol. 2013;2:S155.

ReferenceCitation: Thornton S, Valenzuela G, Baidoo C, Fossler MJ, Montague TH, Clayton L, Powell M, Snidow J, Stier B, Soergel D. Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose-ranging study. Br J Clin Pharmacol. 2017 Oct;83(10):2283-2291. doi: 10.1111/bcp.13336. Epub 2017 Jul 11.

ReferenceCitation: Thornton S, Miller H, Valenzuela G, Snidow J, Stier B, Fossler MJ, Montague TH, Powell M, Beach KJ. Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study. Br J Clin Pharmacol. 2015 Oct;80(4):740-9. doi: 10.1111/bcp.12646. Epub 2015 Jun 1. Erratum in: Br J Clin Pharmacol. 2015 Sep;80(3):609.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
France
Bulgaria
Lithuania
Singapore
Argentina
Puerto Rico
Spain
United States
United Kingdom
Korea, Republic of
Colombia


ReferenceCitation: Orlowski RZ, Gercheva L, Williams C, Sutherland H, Robak T, Masszi T, Goranova-Marinova V, Dimopoulos MA, Cavenagh JD, Špička I, Maiolino A, Suvorov A, Bladé J, Samoylova O, Puchalski TA, Reddy M, Bandekar R, van de Velde H, Xie H, Rossi JF. A phase 2, randomized, double-blind, placebo-controlled study of siltuximab (anti-IL-6 mAb) and bortezomib versus bortezomib alone in patients with relapsed or refractory multiple myeloma. Am J Hematol. 2015 Jan;90(1):42-9. doi: 10.1002/ajh.23868.

name: Department of Lymphoma/Myeloma; The University of Texas MD Anderson Cancer Center; Houston Texas

family: Orlowski

full_name: Robert Z. Orlowski

given: Robert Z.

name: University Hospital for Active Treatment “St. Marina,”; Varna Bulgaria

family: Gercheva

full_name: Liana Gercheva

given: Liana

name: Nottingham University Hospitals NHS Trust; Nottingham United Kingdom

family: Williams

full_name: Cathy Williams

given: Cathy

name: Vancouver General Hospital; Vancouver Canada

family: Sutherland

full_name: Heather Sutherland

given: Heather

name: Medical University of Łódź and Copernicus Memorial Hospital; Łódź Poland

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

name: St. Istvan and St. Laszlo Hospital of Budapest and Semmelweis University; Budapest Hungary

family: Masszi

full_name: Tamás Masszi

given: Tamás

name: University Multiprofile Hospital for Active Treatment “St. George,”; Plovdiv Bulgaria

family: Goranova-Marinova

full_name: Vesselina Goranova-Marinova

given: Vesselina

name: National and Kapodistrian University of Athens; Athens Greece

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

name: St. Bartholomew's and the London Hospital; London United Kingdom

family: Cavenagh

full_name: James D. Cavenagh

given: James D.

name: Charles University in Prague; Prague Czech Republic

family: Špička

full_name: Ivan Špička

given: Ivan

name: Universidade Federal do Rio de Janeiro; Rio de Janeiro Brazil

family: Maiolino

full_name: Angelo Maiolino

given: Angelo

name: First Republican Clinical Hospital of Udmurtia; Izhevsk Russia

family: Suvorov

full_name: Alexander Suvorov

given: Alexander

name: Hospital Clinic i Provincial and Institut d'Investigacions Biomediques August Pi I Sunyer; Barcelona Spain

family: Bladé

full_name: Joan Bladé

given: Joan

name: Nizhniy Novgorod Region Clinical Hospital; Nizniy Novgorod Russia

family: Samoylova

full_name: Olga Samoylova

given: Olga

name: Janssen Research & Development; Spring House Pennsylvania

family: Puchalski

full_name: Thomas A. Puchalski

given: Thomas A.

family: Reddy

full_name: Manjula Reddy

given: Manjula

family: Bandekar

full_name: Rajesh Bandekar

given: Rajesh

name: Janssen Research & Development; Beerse Belgium

family: van de Velde

full_name: Helgi van de Velde

given: Helgi

family: Xie

full_name: Hong Xie

given: Hong

name: University Hospital CHU Saint Eloi and INSERM U1040; Montpellier France

family: Rossi

full_name: Jean-Franςois Rossi

given: Jean-Franςois

journal_name: American Journal of Hematology

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

location_country:
Brazil
United States
Netherlands
Spain
Germany
France
Bulgaria
Czechia
Greece
Poland
Romania
Hungary
Belgium
Russian Federation
Slovakia
Portugal
Canada
United Kingdom

title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade Versus Velcade Alone in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.


title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome

summary: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.

primary_purpose: Diagnostic

location_country: Germany Australia France


title: A Randomized, Double-blind, Placebo Controlled, Multicentre, Phase II Study of Oral Lapatinib in Combination With Concurrent Radiotherapy and Cisplatin Versus Radiotherapy and Cisplatin Alone, in Subjects With Stage III, IVA, B Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.

ReferenceCitation: Harrington K, Berrier A, Robinson M, Remenar E, Housset M, de Mendoza FH, Fayette J, Mehanna H, El-Hariry I, Compton N, Franklin N, Biswas-Baldwin N, Lau M, Legenne P, Kumar R. Randomised Phase II study of oral lapatinib combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck: rationale for future randomised trials in human papilloma virus-negative disease. Eur J Cancer. 2013 May;49(7):1609-18. doi: 10.1016/j.ejca.2012.11.023. Epub 2012 Dec 19.

ReferenceCitation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. Review.

family: Psyrri

full_name: A. Psyrri

given: A.

family: Rampias

full_name: T. Rampias

given: T.

family: Vermorken

full_name: J.B. Vermorken

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
Peru
India
Netherlands
France
Hungary
Spain
United States
United Kingdom
Canada


title: A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction

summary:
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

ReferenceCitation: Shorr AF, Janes JM, Artigas A, Tenhunen J, Wyncoll DL, Mercier E, Francois B, Vincent JL, Vangerow B, Heiselman D, Leishman AG, Zhu YE, Reinhart K; RESPOND investigators. Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated). Crit Care. 2010;14(6):R229. doi: 10.1186/cc9382. Epub 2010 Dec 21.

family: Shorr

full_name: Andrew F Shorr

given: Andrew F

family: Janes

full_name: Jonathan M Janes

given: Jonathan M

family: Artigas

full_name: Antonio Artigas

given: Antonio

family: Tenhunen

full_name: Jyrki Tenhunen

given: Jyrki

family: Wyncoll

full_name: Duncan LA Wyncoll

given: Duncan LA

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Francois

full_name: Bruno Francois

given: Bruno

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

family: Vangerow

full_name: Burkhard Vangerow

given: Burkhard

family: Heiselman

full_name: Darell Heiselman

given: Darell

family: Leishman

full_name: Amy G Leishman

given: Amy G

family: Zhu

full_name: Yajun E Zhu

given: Yajun E

family: Reinhart

full_name: Konrad Reinhart

given: Konrad

family: Investigators

full_name: for the RESPOND Investigators

given: for the RESPOND

currency_apc_doaj: GBP

journal_name: Critical Care

license: cc-by

license_normalized: cc-by

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_normalized: HAL

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

location_country:
United States
Germany
Finland
France
Belgium
Puerto Rico
Spain
Canada
United Kingdom

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


title: Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection

acronym: INSIGHT

summary: The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

ReferenceCitation: Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, González-García J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.

family: Montes

full_name: Maria Luisa Montes

given: Maria Luisa

family: Nelson

full_name: Mark Nelson

given: Mark

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Sasadeusz

full_name: Joe Sasadeusz

given: Joe

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Grinsztejn

full_name: Beatriz Grinsztejn

given: Beatriz

family: Zakharova

full_name: Natalia Zakharova

given: Natalia

family: Rivero

full_name: Antonio Rivero

family: Durant

full_name: Jacques Durant

given: Jacques

family: Ortega-Gonzalez

full_name: Enrique Ortega-Gonzalez

given: Enrique

family: Lathouwers

full_name: Erkki Lathouwers

given: Erkki

family: Janssen

full_name: Katrien Janssen

given: Katrien

family: Ouwerkerk-Mahadevan

full_name: Sivi Ouwerkerk-Mahadevan

given: Sivi

family: Witek

full_name: James Witek

given: James

family: González-García

full_name: Juan González-García

given: Juan

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Janssen-Cilag International NV

location_country:
Brazil
Sweden
France
Poland
Russian Federation
Australia
Spain
United Kingdom


title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

summary: The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.

design_allocation: Non-Randomized

ReferenceCitation: Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.

family: Arnold

full_name: Lesley M. Arnold

given: Lesley M.

family: Emir

full_name: Birol Emir

given: Birol

family: Murphy

full_name: T. Kevin Murphy

given: T. Kevin

family: Zeiher

full_name: Bernhardt G. Zeiher

given: Bernhardt G.

family: Pauer

full_name: Lynne Pauer

given: Lynne

family: Scott

full_name: Gayle Scott

given: Gayle

family: Petersel

full_name: Danielle Petersel

given: Danielle

journal_name: Clinical Therapeutics

title: Safety Profile and Tolerability of Up to 1 Year of Pregabalin Treatment in 3 Open-Label Extension Studies in Patients With Fibromyalgia

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

location_country:
Italy
Sweden
India
Switzerland
Netherlands
Germany
France
Portugal
Denmark
Canada
United Kingdom
Korea, Republic of


title: An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder

summary: This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.

location_country:
South Africa
Netherlands
Finland
France
Poland
Slovenia
Argentina
Australia
New Zealand
Spain
Germany
Latvia
Korea, Republic of
Taiwan


title: A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.

summary: This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

ReferenceCitation: Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.

family: Clair

full_name: Andrew Clair

given: Andrew

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, Leon T, Zeiher B; A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011 Dec;38(12):2643-52. doi: 10.3899/jrheum.110569. Epub 2011 Oct 1.

family: PAUER

full_name: LYNNE PAUER

given: LYNNE

family: WINKELMANN

full_name: ANDREAS WINKELMANN

given: ANDREAS

family: ARSENAULT

full_name: PIERRE ARSENAULT

given: PIERRE

family: JESPERSEN

full_name: ANDERS JESPERSEN

given: ANDERS

family: WHELAN

full_name: LAURENCE WHELAN

given: LAURENCE

family: ATKINSON

full_name: GARY ATKINSON

given: GARY

family: LEON

full_name: TERESA LEON

given: TERESA

family: ZEIHER

full_name: BERNHARDT ZEIHER

given: BERNHARDT

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

title: An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients with Fibromyalgia

ReferenceCitation: Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.

family: Straube

full_name: Sebastian Straube

given: Sebastian

family: Moore

full_name: R Andrew Moore

given: R Andrew

family: Paine

full_name: Jocelyn Paine

given: Jocelyn

family: Derry

full_name: Sheena Derry

given: Sheena

family: Phillips

full_name: Ceri J Phillips

given: Ceri J

family: Hallier

full_name: Ernst Hallier

given: Ernst

family: McQuay

full_name: Henry J McQuay

given: Henry J

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

title: Interference with work in fibromyalgia - effect of treatment with pregabalin and relation to pain response

ReferenceCitation: Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.

ReferenceCitation: Bennett RM, Russell J, Cappelleri JC, Bushmakin AG, Zlateva G, Sadosky A. Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis. BMC Musculoskelet Disord. 2010 Jun 28;11:134. doi: 10.1186/1471-2474-11-134.

location_country:
Italy
Sweden
India
Switzerland
Mexico
Netherlands
Germany
Spain
France
Venezuela
Australia
Portugal
Denmark
Canada
United Kingdom
Korea, Republic of


lead_sponsor: UCB Pharma

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

title: Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

summary: The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.


title: DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)

summary: This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more antihypertensive drugs, including a diuretic.

ReferenceCitation: Weber MA, Black H, Bakris G, Krum H, Linas S, Weiss R, Linseman JV, Wiens BL, Warren MS, Lindholm LH. A selective endothelin-receptor antagonist to reduce blood pressure in patients with treatment-resistant hypertension: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 24;374(9699):1423-31. doi: 10.1016/S0140-6736(09)61500-2. Epub 2009 Sep 11.

family: Weber

full_name: Michael A Weber

given: Michael A

family: Black

full_name: Henry Black

given: Henry

family: Bakris

full_name: George Bakris

given: George

family: Krum

full_name: Henry Krum

family: Linas

full_name: Stuart Linas

given: Stuart

family: Weiss

full_name: Robert Weiss

given: Robert

family: Linseman

full_name: Jennifer V Linseman

given: Jennifer V

family: Wiens

full_name: Brian L Wiens

given: Brian L

family: Warren

full_name: Marshelle S Warren

given: Marshelle S

family: Lindholm

full_name: Lars H Lindholm

given: Lars H

journal_name: The Lancet

lead_sponsor: Gilead Sciences

location_country:
Italy
Brazil
United States
Sweden
Germany
France
Argentina
Spain
Denmark
Canada
United Kingdom

location_facility: Northeast Clinical Research Centers, Inc.

location_facility: Centro Integrado Hospital do Rim e Hipertensao

location_facility: Green and Seidner Family Practice Associates

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: MedStar Diabetes Institute at Washington Hospital Center

location_facility: Hospital de Clinicas da Universidade Federal do Parana

location_facility: Castlerock Clinical Research Consultants

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Azienda Ospedaliera University of Padua Policlinico

location_facility: Texas Tech University Health Sciences Center

location_facility: Maryland Medical Research/Og Medical Center

location_facility: Hôpital Civil, Service HTA maladies vasculaires

location_facility: Cardiovascular Research, Karolinska Institue

location_facility: Nephrology and Hypertension / Hurley Medical Center


title: A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

summary: The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).

lead_sponsor: EMD Serono

location_country:
United States
South Africa
Germany
France
Bulgaria
Romania
Hungary
Belgium
Portugal
Canada
United Kingdom


title: A Phase I/II, Ascending Multi-Dose Study of BMS-663513, An Agonistic Anti-CD137 Monoclonal Antibody, Administered Every Three Weeks to Patients With Metastatic or Locally Advanced Solid Malignancies

summary: This is a Phase I/II, ascending, multi-dose study of BMS-663513, an agonistic anti-CD137 monoclonal antibody, administered every three weeks to patients with metastatic or locally advanced solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Canada
France

location_facility:
Indiana University Cancer Center
Yale University School Of Medicine
Beth Israel Deaconess Medical Center
Hillman Cancer Center
City Of Hope National Medical Center
Local Institution
Dartmouth-Hitchcock Medical Center


title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This study will assess the efficacy and safety of modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

ReferenceCitation: Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.

name: Paracelsus-Elena Klinik, Kassel 34128, Germany; Department of Neurosurgery; University Medical Center; Goettingen Germany

family: Trenkwalder

full_name: Claudia Trenkwalder

given: Claudia

family: Stocchi

full_name: Fabrizio Stocchi

given: Fabrizio

name: Department of Neurology; Medical University; Innsbruck Austria

family: Poewe

full_name: Werner Poewe

given: Werner

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

family: Dronamraju

full_name: Nalina Dronamraju

given: Nalina

family: Kenney

full_name: Chris Kenney

given: Chris

family: Shah

full_name: Amy Shah

given: Amy

family: von Raison

full_name: Florian von Raison

given: Florian

family: Graf

full_name: Ana Graf

given: Ana

journal_name: Movement Disorders

title: Mavoglurant in Parkinson's patients withl-Dopa-induced dyskinesias: Two randomized phase 2 studies

location_country:
Italy
Austria
Switzerland
Germany
France
Slovakia
Hungary
Spain
United States
Canada


title: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

summary: This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.

ReferenceCitation: Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.

name: Hematology Department Haemophilia and Thrombosis Center San Bortolo Hospital Vicenza Italy

family: Tosetto

full_name: Alberto Tosetto

given: Alberto

name: Department of Hematology/Oncology Cleveland Clinic Cleveland OH USA

family: Neff

full_name: Anne Neff

given: Anne

name: Division of Hematology, Oncology, and Blood & Marrow Transplantation Department of Internal Medicine University of Iowa Carver College of Medicine Iowa City IA USA

family: Lentz

full_name: Steven R. Lentz

given: Steven R.

name: Fondazione IRCCS Cà Granda ‐ Ospedale Maggiore Policlinico Angelo Bianchi Bonomi Haemophilia and Thrombosis Center Milan Italy

family: Santagostino

full_name: Elena Santagostino

given: Elena

name: National Haemophilia Centre and Haemostasis Department Medical Centre of Hungarian Defence Forces Budapest Hungary

family: Nemes

full_name: Laszlo Nemes

given: Laszlo

name: Department of Haematology Ampang Hospital Selangor Malaysia

family: Sathar

full_name: Jameela Sathar

given: Jameela

name: Department of Haematology University Medical Centre Groningen University of Groningen Groningen The Netherlands

family: Meijer

full_name: Karina Meijer

given: Karina

name: Katharine Dormandy Haemophilia and Thrombosis Centre Royal Free Hospital London UK

family: Chowdary

full_name: Pratima Chowdary

given: Pratima

family: Shen

full_name: Chunduo Shen

given: Chunduo

family: Landorph

full_name: Andrea Landorph

given: Andrea

name: Department of Cardiovascular Science University of Sheffield Sheffield UK

family: Hampton

full_name: Kingsley Hampton

given: Kingsley

journal_name: Haemophilia

version: submittedVersion

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

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Australia
Denmark
Taiwan
Croatia
France
Japan
Norway
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Israel
Spain
Turkey


title: Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

summary: This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

ReferenceCitation: Wick W, Puduvalli VK, Chamberlain MC, van den Bent MJ, Carpentier AF, Cher LM, Mason W, Weller M, Hong S, Musib L, Liepa AM, Thornton DE, Fine HA. Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma. J Clin Oncol. 2010 Mar 1;28(7):1168-74. doi: 10.1200/JCO.2009.23.2595. Epub 2010 Feb 1.

name: From the University of Heidelberg, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; H. Lee Moffitt Cancer Center, Tampa, FL; Erasmus Medisch Centrum, Rotterdam, the Netherlands; Hopital Pitie Salpetriere, Paris, France; Austin Health, Victoria, Australia; Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada; Eli Lilly and Company, Indianapolis, IN; and Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD.

family: Wick

full_name: Wolfgang Wick

given: Wolfgang

family: Puduvalli

full_name: Vinay K. Puduvalli

given: Vinay K.

family: Chamberlain

full_name: Marc C. Chamberlain

given: Marc C.

family: van den Bent

full_name: Martin J. van den Bent

given: Martin J.

family: Carpentier

full_name: Antoine F. Carpentier

given: Antoine F.

family: Cher

full_name: Lawrence M. Cher

given: Lawrence M.

family: Mason

full_name: Warren Mason

given: Warren

family: Weller

full_name: Michael Weller

given: Michael

family: Hong

full_name: Shengyan Hong

given: Shengyan

family: Musib

full_name: Luna Musib

given: Luna

family: Liepa

full_name: Astra M. Liepa

given: Astra M.

family: Thornton

full_name: Donald E. Thornton

given: Donald E.

family: Fine

full_name: Howard A. Fine

given: Howard A.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Study of Enzastaurin Compared With Lomustine in the Treatment of Recurrent Intracranial Glioblastoma

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

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


title: Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

summary: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

lead_sponsor: Bayer

location_country:
Italy
Austria
United Kingdom
France
Bulgaria
Poland
Belgium
Spain
Germany
Slovenia


title: A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

summary: This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

ReferenceCitation: Giangrande P, Chowdary P, Enhrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WHO, Oldenburg J and on behalf of for the pathfinder™2 Investigators. Clinical evaluation of novel recombinant glycopegylated FVIII (turoctocog alfa pegol, N8-GP): efficacy and safety in previously treated patients with severe hemophilia A - results of pathfinder™2 international trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR212]

ReferenceCitation: Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jönsson PG, Oldenburg J; Pathfinder™2 Investigators. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost. 2017 Jan 26;117(2):252-261. doi: 10.1160/TH16-06-0444. Epub 2016 Dec 1. Erratum in: Thromb Haemost. 2017 Jun;117(6):1163.

family: Giangrande

full_name: Paul Giangrande

given: Paul

family: Andreeva

full_name: Tatiana Andreeva

given: Tatiana

family: Chowdary

full_name: Pratima Chowdary

given: Pratima

family: Ehrenforth

full_name: Silke Ehrenforth

given: Silke

family: Hanabusa

full_name: Hideji Hanabusa

given: Hideji

family: Leebeek

full_name: Frank W. G. Leebeek

given: Frank W. G.

family: Lentz

full_name: Steven R. Lentz

given: Steven R.

family: Nemes

full_name: Laszlo Nemes

given: Laszlo

family: Poulsen

full_name: Lone Hvitfeldt Poulsen

given: Lone Hvitfeldt

family: Santagostino

full_name: Elena Santagostino

given: Elena

family: You

full_name: Chur Woo You

given: Chur Woo

family: Ong Clausen

full_name: Wan Hui Ong Clausen

given: Wan Hui

family: Jönsson

full_name: Peter G. Jönsson

given: Peter G.

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Giangrande P, Abdul Karim F, Nemes L, You CW, Landorph A, Geybels MS, Curry N. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. J Thromb Haemost. 2020 Sep;18 Suppl 1:5-14. doi: 10.1111/jth.14959.

name: Department of Clinical and Laboratory Sciences University of Oxford Oxford UK

name: National Blood Centre Kuala Lumpur Malaysia

family: Abdul Karim

full_name: Faraizah Abdul Karim

given: Faraizah

name: National Hemophilia Center Hemostasis Department Medical Center Hungarian Defence Forces Budapest Hungary

name: Pediatric Department Eulji University Hospital Daejeon Republic of Korea

family: Geybels

name: Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre Churchill Hospital Oxford UK

title: Long‐term safety and efficacy of N8‐GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2

location_country:
Malaysia
Australia
Russian Federation
Denmark
Taiwan
Croatia
France
Japan
Norway
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Brazil
Israel
Spain
Turkey


title: REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy (CRT) can help slow the progression of heart failure in people who have mild or previous symptoms and poor heart pumping function. This kind of therapy has previously been shown to reduce symptoms and improve exercise capacity in people with more advanced forms of heart failure.

ReferenceCitation: Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

family: Linde

full_name: Cecilia Linde

given: Cecilia

family: Abraham

full_name: William T. Abraham

given: William T.

family: Gold

full_name: Michael R. Gold

given: Michael R.

family: St. John Sutton

full_name: Martin St. John Sutton

given: Martin

family: Ghio

full_name: Stefano Ghio

given: Stefano

family: Daubert

full_name: Claude Daubert

given: Claude

journal_name: Journal of the American College of Cardiology

title: Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms

ReferenceCitation: Linde C, Gold M, Abraham WT, Daubert JC; REVERSE Study Group. Baseline characteristics of patients randomized in The Resynchronization Reverses Remodeling In Systolic Left Ventricular Dysfunction (REVERSE) study. Congest Heart Fail. 2008 Mar-Apr;14(2):66-74.

ReferenceCitation: Gold MR, Rickard J, Daubert JC, Zimmerman P, Linde C. Redefining the Classifications of Response to Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2021 Jul;7(7):871-880. doi: 10.1016/j.jacep.2020.11.010. Epub 2021 Feb 24.

family: Rickard

full_name: John Rickard

given: John

full_name: J. Claude Daubert

given: J. Claude

family: Zimmerman

full_name: Patrick Zimmerman

given: Patrick

journal_name: JACC: Clinical Electrophysiology

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

ReferenceCitation: Senfield J, Daubert C, Abraham WT, Ghio S, St John Sutton M, Cerkvenik J, Linde C, Gold MR. The Impact of the PR Interval in Patients Receiving Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2017 Aug;3(8):818-826. doi: 10.1016/j.jacep.2017.01.017. Epub 2017 Apr 26.

family: Senfield

full_name: Jeffrey Senfield

given: Jeffrey

ReferenceCitation: Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4. Review.

name: Heart and Vascular Theme; Karolinska University Hospital, Stockholm, Sweden; and Karolinska Institutet Stockholm; Sweden

name: Robertson Centre for Biostatistics and Clinical Trials; University of Glasgow and National Heart & Lung Institute; Imperial College London UK

name: Medical University of South Carolina; Charleston SC USA

name: Faculté de Médecine; University of Rennes 1; Rennes France

name: The Island Medical Program; University of British Columbia; Vancouver Canada

name: Cleveland Clinic Lerner College of Medicine; Cleveland OH USA

name: Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute; The Ohio State University; Columbus Ohio USA

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Gold MR, Padhiar A, Mealing S, Sidhu MK, Tsintzos SI, Abraham WT. Economic Value and Cost-Effectiveness of Cardiac Resynchronization Therapy Among Patients With Mild Heart Failure: Projections From the REVERSE Long-Term Follow-Up. JACC Heart Fail. 2017 Mar;5(3):204-212. doi: 10.1016/j.jchf.2016.10.014. Epub 2017 Jan 11.

ReferenceCitation: St John Sutton M, Linde C, Gold MR, Abraham WT, Ghio S, Cerkvenik J, Daubert JC; REVERSE Study Group. Left Ventricular Architecture, Long-Term Reverse Remodeling, and Clinical Outcome in Mild Heart Failure With Cardiac Resynchronization: Results From the REVERSE Trial. JACC Heart Fail. 2017 Mar;5(3):169-178. doi: 10.1016/j.jchf.2016.11.012.

ReferenceCitation: St John Sutton M, Cerkvenik J, Borlaug BA, Daubert C, Gold MR, Ghio S, Chirinos JA, Linde C, Ky B. Effects of Cardiac Resynchronization Therapy on Cardiac Remodeling and Contractile Function: Results From Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE). J Am Heart Assoc. 2015 Sep 11;4(9):e002054. doi: 10.1161/JAHA.115.002054.

name: Division of Cardiovascular Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

name: Division of Cardiovascular Medicine, Mayo Clinic, Rochester, MN

name: Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

name: Department of Medicine, Karolinska Institutet, Stockholm, Sweden

journal_name: Journal of the American Heart Association

repository_institution: The Pennsylvania State University - CiteSeer X

repositories:
CiteSeerX
PubMed Central
pdfs.semanticscholar.org

repositories_institution: The Pennsylvania State University - CiteSeer X

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Gold MR, Daubert JC, Abraham WT, Hassager C, Dinerman JL, Hudnall JH, Cerkvenik J, Linde C. Implantable defibrillators improve survival in patients with mildly symptomatic heart failure receiving cardiac resynchronization therapy: analysis of the long-term follow-up of remodeling in systolic left ventricular dysfunction (REVERSE). Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1163-8. doi: 10.1161/CIRCEP.113.000570. Epub 2013 Oct 14.

name: From the Division of Cardiology, Medical University of South Carolina, Charleston (M.R.G.); Department of Cardiology, University Hospital, CIC IT, INSERM 642, Rennes, France (J.-C.D.); Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A.); Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark (C.H.); Department of Cardiology, Heart Center Research, LLC, Huntsville, AL (J.L.D.); CRDM Clinical Research, Medtronic Inc., Minneapolis, MN ...

journal_name: Circulation: Arrhythmia and Electrophysiology

title: Implantable Defibrillators Improve Survival in Patients With Mildly Symptomatic Heart Failure Receiving Cardiac Resynchronization Therapy

ReferenceCitation: Linde C, Daubert C, Abraham WT, St John Sutton M, Ghio S, Hassager C, Herre JM, Bergemann TL, Gold MR; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Impact of ejection fraction on the clinical response to cardiac resynchronization therapy in mild heart failure. Circ Heart Fail. 2013 Nov;6(6):1180-9. doi: 10.1161/CIRCHEARTFAILURE.113.000326. Epub 2013 Sep 6.

name: From the Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (C.L.); Département de Cardiologie, Centre Hospitalier Universitaire de Caen, Rennes, France (C.D.); Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH (W.T.A.); Division of Cardiovascular Medicine, Department of Medicine, Perelman School of Medicine, Philadelphia, PA (M.S.J.S.); Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (S.G.);...

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

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

title: Impact of Ejection Fraction on the Clinical Response to Cardiac Resynchronization Therapy in Mild Heart Failure

ReferenceCitation: Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29. Review.

ReferenceCitation: Linde C, Gold MR, Abraham WT, St John Sutton M, Ghio S, Cerkvenik J, Daubert C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction Study Group. Long-term impact of cardiac resynchronization therapy in mild heart failure: 5-year results from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study. Eur Heart J. 2013 Sep;34(33):2592-9. doi: 10.1093/eurheartj/eht160. Epub 2013 May 2.

name: Department of Cardiology, Karolinska University Hospital, S- 17176, Stockholm, Sweden

name: Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA

name: Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH, USA

name: University of Pennsylvania Medical Center, Philadelphia, PA, USA

name: Département de Cardiologie, CHU, INCERM, CIC_IT 804 Rennes, France

name: on behalf of the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group

ReferenceCitation: Gold MR, Thébault C, Linde C, Abraham WT, Gerritse B, Ghio S, St John Sutton M, Daubert JC. Effect of QRS duration and morphology on cardiac resynchronization therapy outcomes in mild heart failure: results from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study. Circulation. 2012 Aug 14;126(7):822-9. doi: 10.1161/CIRCULATIONAHA.112.097709. Epub 2012 Jul 10.

name: From the Medical University of South Carolina, Charleston (M.R.G.); Department of Cardiology, University Hospital, CIC IT, INSERM 642, Rennes, France (C.T., J.-C.D.); Karolinska University Hospital, Stockholm, Sweden (C.L.); Ohio State University, Columbus (W.T.A.); Medtronic Bakken Research Center BV, Maastricht, the Netherlands (B.G.); Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (S.G.); and University of Pennsylvania Medical Center, Philadelphia (M.S.J.S.).

title: Effect of QRS Duration and Morphology on Cardiac Resynchronization Therapy Outcomes in Mild Heart Failure

ReferenceCitation: Thébault C, Donal E, Meunier C, Gervais R, Gerritse B, Gold MR, Abraham WT, Linde C, Daubert JC; REVERSE study group. Sites of left and right ventricular lead implantation and response to cardiac resynchronization therapy observations from the REVERSE trial. Eur Heart J. 2012 Nov;33(21):2662-71. doi: 10.1093/eurheartj/ehr505. Epub 2012 Jan 26.

ReferenceCitation: Gold MR, Linde C, Abraham WT, Gardiwal A, Daubert JC. The impact of cardiac resynchronization therapy on the incidence of ventricular arrhythmias in mild heart failure. Heart Rhythm. 2011 May;8(5):679-84. doi: 10.1016/j.hrthm.2010.12.031. Epub 2010 Dec 23.

ReferenceCitation: Linde C, Abraham WT, Gold MR, Daubert C; REVERSE Study Group. Cardiac resynchronization therapy in asymptomatic or mildly symptomatic heart failure patients in relation to etiology: results from the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. J Am Coll Cardiol. 2010 Nov 23;56(22):1826-31. doi: 10.1016/j.jacc.2010.05.055.

title: Cardiac Resynchronization Therapy in Asymptomatic or Mildly Symptomatic Heart Failure Patients in Relation to Etiology

ReferenceCitation: Linde C, Daubert C. Cardiac resynchronization therapy in patients with New York Heart Association class I and II heart failure: an approach to 2010. Circulation. 2010 Sep 7;122(10):1037-43. doi: 10.1161/CIRCULATIONAHA.109.923094. Review.

name: From the Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (C.L.), and Département de Cardiologie, Centre Cardio-pneumologique, CHU, Rennes, France (C.D.).

title: Cardiac Resynchronization Therapy in Patients With New York Heart Association Class I and II Heart Failure

ReferenceCitation: St John Sutton M, Ghio S, Plappert T, Tavazzi L, Scelsi L, Daubert C, Abraham WT, Gold MR, Hassager C, Herre JM, Linde C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation. 2009 Nov 10;120(19):1858-65. doi: 10.1161/CIRCULATIONAHA.108.818724. Epub 2009 Oct 26.

name: From the University of Pennsylvania Medical Center (M.S.J.S., T.P.), Philadelphia, Pa; Policlinico San Matteo (S.G., L.S.), Pavia, Italy; GVM Hospitals of Care and Research (L.T.), Cotignola, Italy; Département de Cardiologie (C.D.), Centre Hospitalier Universitaire, Rennes, France; Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute (W.T.A.), The Ohio State University, Columbus, Ohio; Division of Cardiology (M.R.G.), Medical University of South Carolina, Charleston,...

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

title: Cardiac Resynchronization Induces Major Structural and Functional Reverse Remodeling in Patients With New York Heart Association Class I/II Heart Failure

ReferenceCitation: Daubert C, Gold MR, Abraham WT, Ghio S, Hassager C, Goode G, Szili-Török T, Linde C; REVERSE Study Group. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009 Nov 10;54(20):1837-46. doi: 10.1016/j.jacc.2009.08.011. Epub 2009 Oct 1.

title: Prevention of Disease Progression by Cardiac Resynchronization Therapy in Patients With Asymptomatic or Mildly Symptomatic Left Ventricular Dysfunction

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
United States
Sweden
United Kingdom
Germany
France
Norway
Hungary
Belgium
Ireland
Spain
Denmark
Canada
Czech Republic


title: A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

summary: The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.

ReferenceCitation: Colombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, Scambia G, Engelholm SA, Joly F, Weber D, El-Hashimy M, Li J, Souami F, Wing P, Engelholm S, Bamias A, Schwartz P. Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.

name: Nicoletta Colombo, University of Milan-Bicocca and European Institute of Oncology, Milan; Giovanni Scambia, Policlinico Universitario A. Gemelli, Rome, Italy; Elzbieta Kutarska, Centrum Onkologii Ziemi Lubelskej, Lublin; Izabella Rzepka-Gorska, Pomeranian Medical University of Szczecin, Szczecin; Mariusz Bidzinski, Centrum Onkologi-Instytut im. Marii Sklodowskiej-Curie, Warszawa, Poland; Meletios Dimopoulos and Aristotelis Bamias, University of Athens, Athens, Greece; Duk-Soo Bae, Sungkyunkwan University...

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Kutarska

full_name: Elzbieta Kutarska

given: Elzbieta

family: Dimopoulos

full_name: Meletios Dimopoulos

given: Meletios

family: Bae

full_name: Duk-Soo Bae

given: Duk-Soo

family: Rzepka-Gorska

full_name: Izabella Rzepka-Gorska

given: Izabella

family: Bidzinski

full_name: Mariusz Bidzinski

given: Mariusz

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Engelholm

full_name: Svend Aage Engelholm

given: Svend Aage

family: Joly

full_name: Florence Joly

given: Florence

family: Weber

full_name: Dirk Weber

given: Dirk

family: El-Hashimy

full_name: Mona El-Hashimy

given: Mona

family: Li

full_name: Jingjin Li

given: Jingjin

family: Souami

full_name: Farida Souami

given: Farida

family: Wing

full_name: Patricia Wing

given: Patricia

full_name: Silke Engelholm

given: Silke

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: Schwartz

full_name: Peter Schwartz

given: Peter

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Randomized, Open-Label, Phase III Study Comparing Patupilone (EPO906) With Pegylated Liposomal Doxorubicin in Platinum-Refractory or -Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian Tube, or Primary Peritoneal Cancer

location_country:
Italy
United States
South Africa
Finland
France
Poland
Greece
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Southeast Nebraska Oncology/Southeast Nebraska Cancer Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Memorial Health University Medical Center

location_facility: Oncology & Hematology Associates of West Broward

location_facility: Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation

location_facility: GYN Oncology Research/Gynecologic Oncology Research & Development, LLC

location_facility: Washington Hospital Center/Medstar Research Institute

location_facility: St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute

location_facility: Alaska Cancer Research & Education Center

location_facility: Anschutz Cancer Pavilion - Clinical Investigations Core

location_facility: California Pacific Medical Center Research Institute

location_facility: New Hanover Regional Medical Center/Zimmer Cancer Center

location_facility: Minnesota Oncology/Hematology Associates of Central Illinois

location_facility: Northern Indiana Cancer Research Consortium

location_facility: University Of Colorado Health Sciences Center

location_facility: Virginia Commonwealth University/VCU Massey Cancer Center

location_facility: Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: University of California - San Diego/ Moores Cancer Center

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: Washington University School of Medicine

location_facility: Kapiolani Medical Center for Women and Children/Univ. of HI

location_facility: Boston University Medical Center Hospital

location_facility: Hematology and Oncology Associates of Northern New Jersey

location_facility: Cancer Institute of Central Illinois/Decatur Memorial Hospital

location_facility: Northern Virginia Pelvic Surgery Associates

location_facility: St. Vincent Catholic Medical Center of New York

location_facility: New York University School of Medicine/NYU Cancer Institute

location_facility: Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center

location_facility: University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey

location_facility: Miami Cancer Center at University Hospital