title: Rate of Progression in USH2A-related Retinal Degeneration

summary: The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with USH2A related retinal degeneration associated with congenital hearing loss (Usher syndrome type 2a) or non-syndromic retinitis pigmentosa (RP39).

ipd_sharing_description: A de-identified database is available upon request through the public domain on the FFB/Jaeb public website.

lead_sponsor: Jaeb Center for Health Research

location_country:
United States
Netherlands
France
Germany
United Kingdom
Canada

location_facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Kellogg Eye Center, University of Michigan


title: Assessment of the Carillon® Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation

summary: The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating heart failure with at least mild functional regurgitation.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tübler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

ReferenceCitation: Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

ReferenceCitation: Lipiecki J, Siminiak T, Sievert H, Müller-Ehmsen J, Degen H, Wu JC, Schandrin C, Kalmucki P, Hofmann I, Reuter D, Goldberg SL, Haude M. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411. doi: 10.1136/openhrt-2016-000411. eCollection 2016.

ipd_sharing: No

lead_sponsor: Cardiac Dimensions, Inc.

location_country:
Poland
France
Greece
United States
United Kingdom

location_facility: Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers

location_facility: Vassar Brothers- Hudson Valley Cardiovascular Practice

location_facility: New York Presbyterian- Weill Cornell Medical College

location_facility: Lindner Research Center at the Christ Hospital

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Schattenberg JM, Pares A, Kowdley KV, Heneghan MA, Caldwell S, Pratt D, Bonder A, Hirschfield GM, Levy C, Vierling J, Jones D, Tailleux A, Staels B, Megnien S, Hanf R, Magrez D, Birman P, Luketic V. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA. J Hepatol. 2021 Jun;74(6):1344-1354. doi: 10.1016/j.jhep.2021.01.013. Epub 2021 Jan 21.

family: Schattenberg

full_name: Jörn M. Schattenberg

given: Jörn M.

sequence: first

family: Pares

full_name: Albert Pares

given: Albert

sequence: additional

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Heneghan

full_name: Michael A. Heneghan

given: Michael A.

family: Caldwell

full_name: Stephen Caldwell

given: Stephen

family: Pratt

full_name: Daniel Pratt

given: Daniel

family: Bonder

full_name: Alan Bonder

given: Alan

family: Hirschfield

full_name: Gideon M. Hirschfield

given: Gideon M.

family: Levy

full_name: Cynthia Levy

given: Cynthia

family: Vierling

full_name: John Vierling

given: John

family: Jones

full_name: David Jones

given: David

family: Tailleux

full_name: Anne Tailleux

given: Anne

family: Staels

full_name: Bart Staels

given: Bart

family: Megnien

full_name: Sophie Megnien

given: Sophie

family: Hanf

full_name: Remy Hanf

given: Remy

family: Magrez

full_name: David Magrez

family: Birman

full_name: Pascal Birman

given: Pascal

family: Luketic

full_name: Velimir Luketic

given: Velimir

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Hepatology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

status: Completed

lead_sponsor: Genfit

enrollment_type: Actual

location_country:
United States
France
Spain
Germany
United Kingdom

location_facility: University of Birmingham Centre for Liver Research

location_facility: The Newcastle Upon Tyne Hosptials NHS Foundation Trust

location_facility: Clinic for Gastroenterology and Hepatology

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

summary: The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).


title: A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

summary: To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Chile
France
Spain
United States
United Kingdom

location_facility: ANI Neurology, PLLC dba Alzheimer's Memory Center

location_facility: Memory Enhancement Center of America, Inc.

location_facility: RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital

location_facility: West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site

location_facility: Pharmaceutical Research Associates, Inc.

location_facility: Greater Manchester Mental Health NHS Foundation Trust

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: CHU de Toulouse - Cite de la sante - Gerontople

status_simplified: Completed


title: An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

summary: The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

ReferenceType: result

ReferenceCitation: Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

lead_sponsor: Gilead Sciences

location_country:
United States
Germany
France
Australia
New Zealand
Canada
United Kingdom

location_facility: New Orleans Center for Clinical Research

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit

location_facility: University of Colorado Denver (Leprino Building)

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: University of Washington/Harborview Medical Center

location_facility: Toronto Centre for Liver Disease (TCLD), Toronto General Hospital

location_facility: Christchurch Clinical Studies Trust, Ltd


title: TAME Cardiac Arrest Trial: Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial

acronym: TAME

summary: The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.

ReferenceCitation: Eastwood GM, Schneider AG, Suzuki S, Peck L, Young H, Tanaka A, Mårtensson J, Warrillow S, McGuinness S, Parke R, Gilder E, Mccarthy L, Galt P, Taori G, Eliott S, Lamac T, Bailey M, Harley N, Barge D, Hodgson CL, Morganti-Kossmann MC, Pébay A, Conquest A, Archer JS, Bernard S, Stub D, Hart GK, Bellomo R. Targeted therapeutic mild hypercapnia after cardiac arrest: A phase II multi-centre randomised controlled trial (the CCC trial). Resuscitation. 2016 Jul;104:83-90. doi: 10.1016/j.resuscitation.2016.03.023. Epub 2016 Apr 7.

family: Eastwood

full_name: Glenn M. Eastwood

given: Glenn M.

family: Schneider

full_name: Antoine G. Schneider

given: Antoine G.

family: Suzuki

full_name: Satoshi Suzuki

given: Satoshi

family: Peck

full_name: Leah Peck

given: Leah

family: Young

full_name: Helen Young

given: Helen

family: Tanaka

full_name: Aiko Tanaka

given: Aiko

family: Mårtensson

full_name: Johan Mårtensson

given: Johan

family: Warrillow

full_name: Stephen Warrillow

family: McGuinness

full_name: Shay McGuinness

given: Shay

family: Parke

full_name: Rachael Parke

given: Rachael

family: Gilder

full_name: Eileen Gilder

given: Eileen

family: Mccarthy

full_name: Lianne Mccarthy

given: Lianne

family: Galt

full_name: Pauline Galt

given: Pauline

family: Taori

full_name: Gopal Taori

given: Gopal

family: Eliott

full_name: Suzanne Eliott

given: Suzanne

family: Lamac

full_name: Tammy Lamac

given: Tammy

family: Bailey

full_name: Michael Bailey

given: Michael

family: Harley

full_name: Nerina Harley

given: Nerina

family: Barge

full_name: Deborah Barge

given: Deborah

family: Hodgson

full_name: Carol L. Hodgson

given: Carol L.

family: Morganti-Kossmann

full_name: Maria Cristina Morganti-Kossmann

given: Maria Cristina

family: Pébay

full_name: Alice Pébay

given: Alice

family: Conquest

full_name: Alison Conquest

given: Alison

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

location_country:
Italy
Sweden
Saudi Arabia
United Kingdom
Netherlands
Finland
France
Norway
Ireland
Belgium
Australia
New Zealand
Denmark
Slovenia

location_facility: Cliniques Universitaires de Bruxelles Hospital Erasme


title: Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

summary: Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: New Approaches to Neuroblastoma Therapy Consortium

location_country:
United States
United Kingdom
Canada
France

location_facility: Childrens Hospital Boston, Dana-Farber Cancer Institute.

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospital and Regional Medical Center - Seattle

location_facility: University of Chicago, Comer Children's Hospital

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center


title: An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), biomarker effects, and efficacy of BIIB067 administered to participants with ALS and a confirmed SOD1 mutation.

status: Active, not recruiting

lead_sponsor: Biogen

location_country:
Italy
United States
Germany
France
Japan
Belgium
New Zealand
Canada
United Kingdom


ReferenceCitation: Rivière P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.

family: Rivière

full_name: Pauline Rivière

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Baert

full_name: Filip Baert

given: Filip

family: Lambrecht

full_name: Guy Lambrecht

given: Guy

family: Pariente

full_name: Benjamin Pariente

given: Benjamin

family: Bossuyt

full_name: Peter Bossuyt

given: Peter

family: Buisson

full_name: Anthony Buisson

given: Anthony

family: Oldenburg

full_name: Bas Oldenburg

given: Bas

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Laharie

full_name: David Laharie

given: David

journal_name: American Journal of Gastroenterology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

location_country:
Italy
Austria
United States
Germany
France
Czechia
Hungary
Belgium
Spain
Canada
United Kingdom
Ukraine

acronym: DIVERGENCE 1

location_facility: Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1

location_facility: Center for lnterventional Endoscopy- Florida Hospital

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

location_facility: Azienda Ospedaliero - Universitaria Mater Domini

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Medical University of Innsbruck, Department of Internal Medicine I

location_facility: Hospital Universitario Gran Canaria Dr. Negrin

location_facility: Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

location_facility: CHU de Toulouse -Hopital Rangueil (Main Office)

location_facility: Bugát Pál Kórház, Gasztroenterológiai osztály

location_facility: University of South Florida South Tampa campus

location_facility: Indiana University Health University Hospital

location_facility: Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology

location_facility: Gastroenterology Research of San Antonio

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University

location_facility: Royal Devon and Exeter Hospital, Department of Gastroenterology

location_facility: Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma

title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

summary: The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.


title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

acronym: FINCH 4

summary: The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

lead_sponsor: Galapagos NV

location_country:
Malaysia
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Bulgaria
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Serbia
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Porznaniu

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Department of Medicine & Theraputics, The Chinese University of Hong Kong

location_facility: Hospital Regional Universitario de Malaga

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council

location_facility: Spitalul Clinic Judetean de Urgenta Tirgu Mures

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy

location_facility: Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Hôpital Lapeyronie, Service d'Immuno-Rhumatologic

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Daegu Catholic University Medical Center

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Articularis Healthcare Group d/b/a ACME Research

location_facility: Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly

location_facility: Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology

location_facility: Centre De Recherche Musculo Squelettique

location_facility: Arthrocare, Arthritis Care & Research PC

location_facility: Chung-Ang University Hospital Institutional Review Board

location_facility: Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Revmatologicka ambulance, Nuselska Poliklinika

location_facility: Weill Cornell Physicians At Brooklyn Heights

location_facility: Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh

location_facility: Nizhny Novgorod City Clinical Hospital #5

location_facility: Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie

location_facility: State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital

location_facility: Twoja Przychodnia -Centrum Medyzcne Nowa Sol

location_facility: C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Municipal Institution "City Hospital #1", Department of Therapy

location_facility: City Clinical Hospital #4 of Department of Healthcare of Moscow City

location_facility: Military Medical Academy, Clinic of Rheumatology

location_facility: Shri Nidaan Hospital and Hope Fertility Centre

location_facility: Chennai Meenakshi Multispeciality Hospital Ltd

location_facility: Municipal Clinical Hospital No. 15 named after O.M. Filatov

location_facility: Clinical Trial Unit, CCHDB, Wellington Hospital

location_facility: Institute For Treatment And Rehabilitation Niska Banja

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"

location_facility: Rajavithi Hospital, Rheumatology and Allergy Unit

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.

location_facility: Centre for Rheumatic Disease, Hermes Doctor House

location_facility: Articularis Healthcare Group d/b/a Low Country Rheumatology

location_facility: Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine

location_facility: Centro De Investigación Clínica De Morelia, Sc

location_facility: Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"

location_facility: University of Florida College of Medicine, Jacksonville - Rheumatology Research

location_facility: Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: City Clinical Hospital #1, Department of Rheumatology

location_facility: Stanford University Hospitals and Clinics (Immunology & Rheumatology)

location_facility: University of California San Diego (UCSD) - Perlman Ambulatory Clinic

location_facility: Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1

location_facility: Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans

location_facility: PA Regional Center For Arthritis And Osteoporosis Research

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Department of Rheumatology, KG Medical University

location_facility: Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology

location_facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly

location_facility: Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Yoshida orthopaedic and rheumatology Clinic

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

location_facility: Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"

location_facility: MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

location_facility: Kyiv City Clinical Hospital #6, Department of Therapy

location_facility: Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz

location_facility: Centro Peninsular De Investigacion Clinica S.C.P.

location_facility: Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1

location_facility: Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy

location_facility: State Healthcare Institution, Regional Clinical Hospital

location_facility: Keck Medicine of USC- Division of Rheumatology

location_facility: Hospital HM Nuestra Senora de la Esperanza

location_facility: Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2

location_facility: Onganizacion Medica de Investigacion S.A (OMI)

location_facility: The Oklahoma Center For Arthritis Therapy & Research, Inc.

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: "MHAT Lyulin" EAD, Department of Rheumatology

location_facility: State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine

location_facility: Department of Medicine, Queen Mary Hospital

location_facility: Carolina Rheumatology & Neurology Assoc., PC

location_facility: Warrington and Halton Hospitals Nhs Foundation Trust

location_facility: LLC Polyclinic of Private Security Personnel

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy

location_facility: Umass Memorial Medical Center- Memorial Campus

location_facility: Suretech Hospital and Research Centre Pvt Ltd

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Medical College Baroda and Sir Sayajirao General Hospital

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: The Center For Rheumatology And Bone Research

location_facility: Chi Mei Hospital, Chi Mei Medical Center

location_facility: Chonbuk National University Medical School

location_facility: HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"

location_facility: Santokba Durlabhji Memorial Hospital Cum Medical Research Institute

location_facility: Rajiv Gandhi Institute of Medical Sciences and Government General Hospital

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach

location_facility: Municipal Institution City Hospital #7, Department of Therapy

location_facility: Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"

location_facility: M. Vladimirsky Moscow Regional Research Clinical Institute

location_facility: MHAT "Sveta Petka" AD, Department of Internal Diseases

location_facility: Trinity Universal Research Associates, Inc

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department

location_facility: Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso

location_facility: Chanre Rheumatology and Immunology Centre and Research

location_facility: Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Articularis Healthcare Inc., dba Columbia Arthritis Center, PA

location_facility: Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine

location_facility: Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie

location_facility: Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski

location_facility: Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital

location_facility: NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach

location_facility: Rheumatology Associates of North Alabama, PC


title: Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

summary: The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Poland
Belgium
Portugal
Estonia
Canada
United Kingdom

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: CHI St. Luke's Health Baylor College of Medicine

location_facility: Main Line Health Center/Lankenau Hospital

intervention_type: Device


type: Registry Identifier

type: Other Identifier

type: U.S. NIH Grant/Contract

title: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

summary: This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

lead_sponsor: Children's Oncology Group

location_country:
Italy
Austria
United States
Chile
Sweden
Saudi Arabia
Hong Kong
Netherlands
Switzerland
Germany
Finland
France
Czechia
Israel
Australia
Belgium
New Zealand
Puerto Rico
Canada

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Lucile Packard Children's Hospital Stanford University

location_facility: University Medical Center of Southern Nevada

location_facility: Memorial Health University Medical Center

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: University of Mississippi Medical Center

location_facility: University of Iowa/Holden Comprehensive Cancer Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Michigan State University Clinical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Schneider Children's Medical Center of Israel

location_facility: Walter Reed National Military Medical Center

location_facility: Saint Vincent Hospital and Health Care Center

location_facility: Children's Hospital of The King's Daughters

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: University of Oklahoma Health Sciences Center

location_facility: Methodist Children's Hospital of South Texas

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Children's Healthcare of Atlanta - Egleston

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: Golisano Children's Hospital of Southwest Florida

location_facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

location_facility: State University of New York Upstate Medical University

location_facility: BI-LO Charities Children's Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Novant Health Presbyterian Medical Center

location_facility: The Montreal Children's Hospital of the MUHC

location_facility: University of Vermont and State Agricultural College

location_facility: The Steven and Alexandra Cohen Children's Medical Center of New York

location_facility: University of Minnesota/Masonic Cancer Center

location_facility: Children's Hospitals and Clinics of Minnesota - Minneapolis

location_facility: Mary Bridge Children's Hospital and Health Center

location_facility: Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

location_facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital

location_facility: University Medical Center chleswig- Campus Kiel

location_facility: Washington University School of Medicine

location_facility: Children's Hospital Medical Center of Akron

location_facility: Saint Christopher's Hospital for Children

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Saint Vincent Hospital Cancer Center Green Bay

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Sanford USD Medical Center - Sioux Falls

location_facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

location_facility: Miller Children's and Women's Hospital Long Beach

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Montefiore Medical Center - Moses Campus

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM

location_facility: Children's Hospital and Medical Center of Omaha

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Virginia Commonwealth University/Massey Cancer Center

location_facility: ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Princess Máxima Center for Pediatric Oncology

location_facility: Helen DeVos Children's Hospital at Spectrum Health

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: Hospital Roberto del Rio-Universidad de Chile

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: Texas Tech University Health Sciences Center-Amarillo

location_facility: The Children's Hospital at TriStar Centennial

location_facility: McMaster Children's Hospital at Hamilton Health Sciences

location_facility: University of Kentucky/Markey Cancer Center

location_facility: Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center


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

lead_sponsor: Shire

location_country:
Italy
Austria
United States
South Africa
France
Poland
Israel
Hungary
Australia
Puerto Rico
Spain
Estonia
Canada

location_facility: Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH

location_facility: East Tallinn Central Hospital Eye Clinic

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS

location_facility: The Ottawa Hospital - General Campus, University of Ottawa Eye Institute

location_facility: Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)

location_facility: Vienna Institute for Research in Ocular Surgery

location_facility: Cornea and Cataract Consultants of Arizona

location_facility: University of the Sunshine Coast Clinical Trials Centre

location_facility: Advanced Laser Vision & Surgical Institute

location_facility: DCT- Shah Research, LLC dba Discovery Clinical Trials

location_facility: Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

location_facility: Centro Dotal de Investigaciones de Servicios de Salud

location_facility: University of Waterloo School of Optometry and Vision Science

location_facility: Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC

location_facility: Emanuelli Research & Development Center, LLC

title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

summary: The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.


intervention_type: Procedure

lead_sponsor: Kiadis Pharma

primary_purpose: Prevention

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

acronym: HATCY

location_facility: Servicio de Hematología Hospital, Universitari I politècnic La Fe

location_facility: Sourasky Medical Center & Tel Aviv University

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Faculdade de Medicina da Universidade de Lisboa

location_facility: University Hospital Barcelona Vall d' Hebron

location_facility: Hadassah Medical Center & Hadassah Hospital Ein Karem

location_facility: University Hospital Frankfurt, Goethe University

location_facility: Ludwig-Maximilians-University Hospital of Munich-Grosshadern

location_facility: Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

title: A Phase III, Multicenter, Randomized Controlled Study to Compare Safety and Efficacy of a Haploidentical HSCT and Adjunctive Treatment With ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells, Versus a Haploidentical HSCT With Post-transplant Cyclophosphamide in Patients With a Hematologic Malignancy

summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life.


ReferenceCitation: Klamroth R, Feistritzer C, Friedrich U, Lentz SR, Reichwald K, Zak M, Chowdary P. Pharmacokinetics, immunogenicity, safety, and preliminary efficacy of subcutaneous turoctocog alfa pegol in previously treated patients with severe hemophilia A (alleviate 1). J Thromb Haemost. 2020 Feb;18(2):341-351. doi: 10.1111/jth.14660. Epub 2019 Nov 15.

name: Department of Internal Medicine Hemophilia Treatment CentreVivantes Klinikum im Friedrichshain Berlin Germany

family: Klamroth

full_name: Robert Klamroth

given: Robert

name: Internal Medicine V—Hematology and Oncology Medical University of Innsbruck Innsbruck Austria

family: Feistritzer

full_name: Clemens Feistritzer

given: Clemens

family: Friedrich

full_name: Ute Friedrich

given: Ute

name: The University of Iowa Carver College of Medicine Iowa City IA USA

family: Lentz

full_name: Steven R. Lentz

given: Steven R.

family: Reichwald

full_name: Kirsten Reichwald

given: Kirsten

family: Zak

full_name: Marek Zak

given: Marek

name: KD Haemophilia and Thrombosis Centre Royal Free London NHS Foundation Trust London UK

family: Chowdary

full_name: Pratima Chowdary

given: Pratima

journal_name: Journal of Thrombosis and Haemostasis

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Serbia
Germany
France
Japan
United States

acronym: alleviate 1

title: Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

summary: The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.


title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

summary:
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)

This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Polyganics BV

location_country:
Italy
United States
Sweden
France
Spain
Germany
United Kingdom

location_facility: Virginia Commonwealth University Medical Center

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: University Hospital Lund - Department of Hand Surgery

location_facility: The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)

location_facility: Stanford Medical Center Hand and Upper Limb Center

location_facility: Veterans affairs Medical Center Portland


title: An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

acronym: RELAY-1 Extend

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

status: Terminated

location_country:
Italy
Austria
Serbia
United Kingdom
France
Czechia
Bulgaria
Slovakia
Georgia
Romania
Belgium
Spain
Estonia
Latvia

location_facility:
Research Site 2
Research Site
Research Site 1

status_simplified: Unknown


location_country:
Italy
Austria
Serbia
United Kingdom
Netherlands
France
Czechia
Bulgaria
Slovakia
Georgia
Romania
Belgium
Spain
Latvia

location_facility:
Research Site
Reasearch Site

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.


title: Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

acronym: ASPIRE-SSI

summary: ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

lead_sponsor: UMC Utrecht

location_country:
Italy
Serbia
Netherlands
France
Czechia
Romania
Belgium
Spain
Estonia
United Kingdom

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: Institute for Orthopedic Surgery Banjica

location_facility: Prof. C.C. Iliescu Cardiovascular Diseases Institute

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: York Teaching Hospitals NHS Foundation Trust

location_facility: Brighton & Sussex University Hospital NHS Trust

location_facility: Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent

location_facility: Hospital Universitario Central de Asturias

location_facility: The Pennine Acute Hospitals NHS Trust Manchester

location_facility: Carol Davila University of Medicine and Pharmacy Bucharest


title: A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB

summary: This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

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

lead_sponsor: Pfizer

location_country:
United States
France
Poland
Hungary
Russian Federation
Moldova, Republic of
Germany
United Kingdom
Canada

location_facility: Frauenklinik des Universitaetsklinikums Erlangen

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic


title: Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant.

acronym: MOVES-PD

summary:
Primary Objectives:

Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally for 4 weeks, as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA mutation or other pre-specified variants.
Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or other pre-specified variants.

Secondary Objectives:

Part 1:

To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage Parkinson's disease patients carrying a GBA mutation.
To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage Parkinson's disease patients carrying a GBA mutation.

Part 2:

To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage Parkinson's disease patients carrying a GBA mutation as compared to placebo.
To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage Parkinson's disease patients carrying a GBA mutation over a 52-week period.

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Austria
Sweden
Spain
Germany
France
Japan
Greece
Israel
Norway
Singapore
Portugal
United States
United Kingdom
Canada
Taiwan

location_facility:
Investigational Site Number 8400012
Investigational Site Number 3800001
Investigational Site Number 8260002
Investigational Site Number 3800003
Investigational Site Number 1240001
Investigational Site Number 8400008
Investigational Site Number 3920003
Investigational Site Number 8400009
Investigational Site Number 8400021
Investigational Site Number 7020002
Investigational Site Number 8400004
Investigational Site Number 3920001
Investigational Site Number 8400001
Investigational Site Number 7020001
Investigational Site Number 1240002
Investigational Site Number 3760004
Investigational Site Number 0400001
Investigational Site Number 7520001
Investigational Site Number 3800006
Investigational Site Number 6200003
Investigational Site Number 3800004
Investigational Site Number 3800002
Investigational Site Number 2760001
Investigational Site Number 3760001
Investigational Site Number 3920005
Investigational Site Number 8400020
Investigational Site Number 3920004
Investigational Site Number 8400013
Investigational Site Number 2500001
Investigational Site Number 8400019
Investigational Site Number 8400016
Investigational Site Number 2760002
Investigational Site Number 8400006
Investigational Site Number 8400010
Investigational Site Number 3920002
Investigational Site Number 8400002
Investigational Site Number 8400017
Investigational Site Number 3000004
Investigational Site Number 1240003
Investigational Site Number 6200002
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 3000002
Investigational Site Number 3760002
Investigational Site Number 8400015
Investigational Site Number 8400011
Investigational Site Number 1580001
Investigational Site Number 3760003
Investigational Site Number 8400005
Investigational Site Number 8400014
Investigational Site Number 5780001
Investigational Site Number 7240002
Investigational Site Number 8400018


ReferenceCitation: Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May - Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):741.

family: Daniels

full_name: Stephen Daniels

given: Stephen

family: Caprio

full_name: Sonia Caprio

given: Sonia

family: Chaudhari

full_name: Umesh Chaudhari

given: Umesh

family: Manvelian

full_name: Garen Manvelian

given: Garen

family: Baccara-Dinet

full_name: Marie T. Baccara-Dinet

given: Marie T.

family: Brunet

full_name: Aurelie Brunet

given: Aurelie

family: Scemama

full_name: Michel Scemama

given: Michel

family: Loizeau

full_name: Virginie Loizeau

given: Virginie

family: Bruckert

full_name: Eric Bruckert

given: Eric

journal_name: Journal of Clinical Lipidology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Sanofi

location_country:
South Africa
Sweden
Netherlands
France
Czechia
Norway
Russian Federation
Spain
United States
Canada

acronym: ODYSSEY KIDS

location_facility:
Investigational Site Number 2500001
Investigational Site Number 5280001
Investigational Site Number 2030001
Investigational Site Number 7240001
Investigational Site Number 7520001
Investigational Site Number 1240001
Investigational Site Number 2030002
Investigational Site Number 6430004
Investigational Site Number 7240004
Investigational Site Number 8400005
Investigational Site Number 5780001
Investigational Site Number 6430001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 7100001
Investigational Site Number 2030003

title: An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase

summary:
Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

To evaluate the safety and tolerability of alirocumab.
To evaluate the pharmacokinetics profile of alirocumab.
To evaluate the effects of alirocumab on other lipid parameters.


publications_result: Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.

ReferenceCitation: Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Erratum in: JAMA. 2020 Feb 4;323(5):480.

name: Division of Immunology and Rheumatology, Stanford University, Stanford, California

family: Genovese

full_name: Mark C. Genovese

given: Mark C.

name: Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, La Jolla

family: Kalunian

full_name: Kenneth Kalunian

given: Kenneth

name: Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

name: Gilead Sciences Inc, Foster City, California

family: Mozaffarian

full_name: Neelufar Mozaffarian

given: Neelufar

family: Bartok

full_name: Beatrix Bartok

given: Beatrix

family: Matzkies

full_name: Franziska Matzkies

given: Franziska

family: Gao

full_name: Jie Gao

given: Jie

family: Guo

full_name: Ying Guo

given: Ying

family: Tasset

full_name: Chantal Tasset

given: Chantal

family: Sundy

full_name: John S. Sundy

given: John S.

name: Department of Rheumatology, Universitair Ziekenhuis Leuven, Leuven, Belgium

family: de Vlam

full_name: Kurt de Vlam

given: Kurt

name: Northumbria Healthcare, North Shields, United Kingdom

family: Walker

full_name: David Walker

given: David

name: Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

journal_name: JAMA

oa_colors: green other

evidence: open (via free pdf)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2021 Jan 18:1-16. doi: 10.1080/14397595.2020.1859675. [Epub ahead of print]

name: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

name: Department of Orthopedics, Matsubara Mayflower Hospital, Hyogo, Japan

family: Matsubara

full_name: Tsukasa Matsubara

given: Tsukasa

name: Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan

family: Atsumi

full_name: Tatsuya Atsumi

given: Tatsuya

name: Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan

name: Aichi Developmental Disability Center, Aichi, Japan

name: Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan

name: Department of Rheumatology and Infectious Diseases, Kitasato University School of Medicine, Sagamihara, Japan

name: Gilead Sciences Inc, Foster City, CA, USA

name: Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, CA, USA

name: Northumbria Healthcare, North Shields, UK

name: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan

location_country:
Switzerland
Mexico
Germany
France
Japan
Poland
Israel
Hungary
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Korea, Republic of

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

summary: The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.


title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis

summary: This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Sweden
France
New Zealand
United States


title: A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer

summary: The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

ReferenceCitation: Bhagwat SV, McMillen WT, Cai S, Zhao B, Whitesell M, Shen W, Kindler L, Flack RS, Wu W, Anderson B, Zhai Y, Yuan XJ, Pogue M, Van Horn RD, Rao X, McCann D, Dropsey AJ, Manro J, Walgren J, Yuen E, Rodriguez MJ, Plowman GD, Tiu RV, Joseph S, Peng SB. ERK Inhibitor LY3214996 Targets ERK Pathway-Driven Cancers: A Therapeutic Approach Toward Precision Medicine. Mol Cancer Ther. 2020 Feb;19(2):325-336. doi: 10.1158/1535-7163.MCT-19-0183. Epub 2019 Nov 19.

family: Bhagwat

full_name: Shripad V. Bhagwat

given: Shripad V.

family: McMillen

full_name: William T. McMillen

given: William T.

family: Cai

full_name: Shufen Cai

given: Shufen

family: Zhao

full_name: Baohui Zhao

given: Baohui

family: Whitesell

full_name: Matthew Whitesell

given: Matthew

family: Shen

full_name: Weihua Shen

given: Weihua

family: Kindler

full_name: Lisa Kindler

given: Lisa

family: Flack

full_name: Robert S. Flack

given: Robert S.

family: Wu

full_name: Wenjuan Wu

given: Wenjuan

family: Anderson

full_name: Bryan Anderson

given: Bryan

family: Zhai

full_name: Yan Zhai

given: Yan

family: Yuan

full_name: Xiu-Juan Yuan

given: Xiu-Juan

family: Pogue

full_name: Meghann Pogue

given: Meghann

family: Van Horn

full_name: Robert D. Van Horn

given: Robert D.

family: Rao

full_name: Xi Rao

given: Xi

family: McCann

full_name: Denis McCann

given: Denis

family: Dropsey

full_name: Andrew J. Dropsey

given: Andrew J.

family: Manro

full_name: Jason Manro

given: Jason

family: Walgren

full_name: Jennie Walgren

given: Jennie

family: Yuen

full_name: Eunice Yuen

given: Eunice

family: Rodriguez

full_name: Michael J. Rodriguez

given: Michael J.

family: Plowman

full_name: Gregory D. Plowman

given: Gregory D.

family: Tiu

full_name: Ramon V. Tiu

publisher: American Association for Cancer Research (AACR)

title: ERK Inhibitor LY3214996 Targets ERK Pathway–Driven Cancers: A Therapeutic Approach Toward Precision Medicine

location_facility: University of Texas MD Anderson Cancer Center


title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

summary: The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

primary_purpose: Other

ipd_sharing_description: Not yet determined

lead_sponsor: University of Virginia

location_country:
Italy
United States
France
Netherlands

location_facility: Barbara Davis Center, University of Colorado

location_facility: University of Virginia Center for Diabetes Technology

location_facility: Harvard University (Joslin Diabetes Center)

lead_sponsor_type: academique


title: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

acronym: TAURUS

summary:
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.

In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.

lead_sponsor: Bayer

location_country:
Italy
United States
Luxembourg
Netherlands
Germany
France
Greece
Belgium
Spain
Canada
Slovenia
Taiwan
Colombia

location_facility: Children's Hospital at OU Medical Center

location_facility: Washington University Center for Bleeding and Blood Clotting Disorders

location_facility: University of Florida Health Cancer Center

location_facility: East Carolina University - Brody School of Medicine

location_facility: Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

location_facility: Children's Rehabilitation Services/ University of South Alabama

location_facility: Wake Forest University School of Medicine

location_facility: Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

location_facility: Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville

location_facility: University of Colorado Hemophilia and Thrombosis Center

location_facility: Intermountain Hemophilia & Thrombosis Center

intervention_type: Biological


location_country:
Italy
Austria
Switzerland
Spain
Germany
France
Czechia
Lithuania
Poland
Slovakia
Hungary
Portugal
Canada
United Kingdom

acronym: VIOLET

title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)

summary: To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)


title: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)

acronym: PRODIGY

summary:
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.

The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

primary_purpose: Screening

ReferenceCitation: Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8.

ReferenceCitation: Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.

ReferenceCitation: Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. Epub 2004 May 28. Review.

ReferenceCitation: Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.

ReferenceCitation: Khanna AK, Jungquist CR, Buhre W, Soto R, Di Piazza F, Saager L; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Modeling the Cost Savings of Continuous Pulse Oximetry and Capnography Monitoring of United States General Care Floor Patients Receiving Opioids Based on the PRODIGY Trial. Adv Ther. 2021 Jul;38(7):3745-3759. doi: 10.1007/s12325-021-01779-7. Epub 2021 May 24.

family: Khanna

full_name: Ashish K. Khanna

given: Ashish K.

family: Jungquist

full_name: Carla R. Jungquist

given: Carla R.

family: Buhre

full_name: Wolfgang Buhre

given: Wolfgang

family: Soto

full_name: Roy Soto

given: Roy

family: Di Piazza

full_name: Fabio Di Piazza

given: Fabio

family: Saager

full_name: Leif Saager

given: Leif

family: Bergese

full_name: Sergio D. Bergese

given: Sergio D.

family: Morimatsu

full_name: Hiroshi Morimatsu

given: Hiroshi

family: Uezono

full_name: Shoichi Uezono

given: Shoichi

family: Lee

full_name: Simon Lee

given: Simon

family: Ti

full_name: Lian Kah Ti

given: Lian Kah

family: Urman

full_name: Richard D. Urman

given: Richard D.

family: McIntyre

full_name: Robert McIntyre

given: Robert

suffix: Jr

family: Tornero

full_name: Carlos Tornero

given: Carlos

family: Dahan

full_name: Albert Dahan

given: Albert

family: Weingarten

full_name: Toby N. Weingarten

given: Toby N.

family: Wittmann

full_name: Maria Wittmann

given: Maria

family: Auckley

full_name: Dennis Auckley

given: Dennis

family: Brazzi

full_name: Luca Brazzi

given: Luca

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

family: Schramm

full_name: Frank Schramm

given: Frank

family: Overdyk

full_name: Frank J. Overdyk

given: Frank J.

name: the PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators

ReferenceCitation: Khanna AK, Saager L, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Ti LK, Soto R, Jiang W, Buhre W. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol. 2021 Mar 20;21(1):88. doi: 10.1186/s12871-021-01307-8.

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

ReferenceCitation: Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.

ReferenceCitation: Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

name: on behalf of the PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators

ReferenceCitation: Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18. Review.

title: Respiratory depression in low acuity hospital settings–Seeking answers from the PRODIGY trial

location_country:
United States
Netherlands
France
Japan
Singapore
Spain
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: The Ohio State University Wexner Medical Center

location_facility: The Jikei University School of Medicine Hospital

location_facility: Providence Regional Medical Center Everett


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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Hong Kong
Switzerland
Finland
France
Japan
Belgium
Spain
Germany
Korea, Republic of

location_facility: Washington University School of Medicine

title: A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

summary: The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.


title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

summary: Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

status: Unknown status

lead_sponsor: Hybrigenics Corporation

location_country:
United States
France

location_facility: Duke Cancer Institute, Duke Univ Medical Center

location_facility: University of Texas; M D Anderson Cancer Center

location_facility: Georgia Cancer Center-Augusta University


title: A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta

acronym: BALANCE

summary: This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than 50% of the patients will be female.

lead_sponsor: Protalix

location_country:
Italy
Brazil
Switzerland
Netherlands
Spain
Germany
United Kingdom
Finland
France
Czechia
Norway
Hungary
Belgium
Argentina
Australia
Paraguay
Turkey
United States
Slovenia
Canada

location_facility: Institute of Metabolism and Systems Research

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Klinik und Poliklinik für Innere Medizin UniversitätsSpital Zürich

location_facility: Policlinico Universitario Agostino Gemelli, L.go A. Gemelli

location_facility: Department and Laboratory of Pediatric Metabolic Disorders

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

location_facility: Haukeland University Hospital Klinisk Forskningspost

location_facility: University of Florida, Department of Pediatrics/Genetics & Metabolism

location_facility: Azienda Ospedaliero-Universitaria Careggi (SOD Nefrologia)

location_facility: Eccles Primary Children's Outpatient Services Building

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hematology and Clinical Research Private Institute

location_facility: University of Iowa Hosptials and Clinics

location_facility: Institute of Metabolic Disease, Baylor Healthcare


title: Helicobacter Pylori Genome Project (HpGP)

summary:
Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer.

Objectives:

To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer.

Eligibility:

People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer

Design:

Participants will be screened by the doctor who does their procedure and a study nurse.

Participants who have endoscopy will have ~6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam.

Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.

time_perspective: Cross-Sectional

ReferenceCitation: Correa P, Haenszel W, Cuello C, Tannenbaum S, Archer M. A model for gastric cancer epidemiology. Lancet. 1975 Jul 12;2(7924):58-60.

ReferenceCitation: Tomb JF, White O, Kerlavage AR, Clayton RA, Sutton GG, Fleischmann RD, Ketchum KA, Klenk HP, Gill S, Dougherty BA, Nelson K, Quackenbush J, Zhou L, Kirkness EF, Peterson S, Loftus B, Richardson D, Dodson R, Khalak HG, Glodek A, McKenney K, Fitzegerald LM, Lee N, Adams MD, Hickey EK, Berg DE, Gocayne JD, Utterback TR, Peterson JD, Kelley JM, Cotton MD, Weidman JM, Fujii C, Bowman C, Watthey L, Wallin E, Hayes WS, Borodovsky M, Karp PD, Smith HO, Fraser CM, Venter JC. The complete genome sequence of the gastric pathogen Helicobacter pylori. Nature. 1997 Aug 7;388(6642):539-47. Erratum in: Nature 1997 Sep 25;389(6649):412.

ReferenceCitation: Krebes J, Morgan RD, Bunk B, Spröer C, Luong K, Parusel R, Anton BP, König C, Josenhans C, Overmann J, Roberts RJ, Korlach J, Suerbaum S. The complex methylome of the human gastric pathogen Helicobacter pylori. Nucleic Acids Res. 2014 Feb;42(4):2415-32. doi: 10.1093/nar/gkt1201. Epub 2013 Dec 2.

lead_sponsor: National Cancer Institute (NCI)

location_country:
Peru
Guatemala
Jordan
Malaysia
Greece
Belgium
Kyrgyzstan
Russian Federation
Nepal
Taiwan
Iceland
India
Costa Rica
Congo, The Democratic Republic of the
Spain
France
Japan
Lithuania
Poland
Nigeria
Argentina
Indonesia
Canada
Korea, Republic of
Colombia
Iran, Islamic Republic of
Kenya
South Africa
Chile
Sweden
Switzerland
Vietnam
Bulgaria
Singapore
Puerto Rico
Algeria
Portugal
Germany
United States
Italy
Brazil
Sudan
Honduras
Myanmar
Mexico
Cameroon
Dominican Republic
Bangladesh
Israel
Ghana
Kazakhstan
Turkey
Latvia

location_facility: Institut d'Investigació Biomédica de Bellvitge (Idibell)

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Instituto Nacional de Saúde Dr. Ricardo Jorge

location_facility: Centers for Disease Control and Prevention

location_facility: Sudan University of Science and Technology

location_facility: Evangelismos Hospital and Hellenic Pasteur Institute

location_facility: Lithuanian University of Health Sciences

location_facility: University of Jos / University Teaching Hospital

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Jordan University of Science and Technology


title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

summary: The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

lead_sponsor: Eli Lilly and Company

location_country:
Italy
France
Spain
United States
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.

intervention_type: Radiation


location_country:
Italy
United States
Chile
Mexico
Netherlands
Germany
Finland
France
Czechia
Poland
Argentina
Russian Federation
Spain
Canada
United Kingdom

acronym: SKYPP

location_facility:
Investigational Site Number :8400417
Investigational Site Number :1520016
Investigational Site Number :7240052
Investigational Site Number :6430062
Investigational Site Number :4840061
Investigational Site Number :7240053
Investigational Site Number :2760061
Investigational Site Number :8260031
Investigational Site Number :2500040
Investigational Site Number :2760064
Investigational Site Number :1240112
Investigational Site Number :2760063
Investigational Site Number :1240110
Investigational Site Number :6160073
Investigational Site Number :0320060
Investigational Site Number :6430063
Investigational Site Number :3800052
Investigational Site Number :8400416
Investigational Site Number :6430001
Investigational Site Number :0320004
Investigational Site Number :8400418
Investigational Site Number :2460040
Investigational Site Number :2760060
Investigational Site Number :3800053
Investigational Site Number :7240051
Investigational Site Number :7240050
Investigational Site Number :8260033
Investigational Site Number :6160071
Investigational Site Number :6160072
Investigational Site Number :2760062
Investigational Site Number :4840060
Investigational Site Number :3800051
Investigational Site Number :5280020
Investigational Site Number :6160074
Investigational Site Number :6160070
Investigational Site Number :2030041
Investigational Site Number :8400415

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population

Secondary Objective:

To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.


title: Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects

acronym: OSCAR

summary:
This is a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Subjects will have each half-face randomized to one of the two following treatments:

Adapalene 0.3% - BPO 2.5% gel (TactuPump® Forte).
Vehicle gel

The main objective of this trial is to evaluate the effect of Adapalene 0.3% - benzoyl peroxide (BPO) 2.5% gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne subjects.

ReferenceCitation: Dréno B, Bissonnette R, Gagné-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

family: Bissonnette

full_name: Robert Bissonnette

family: Gagné-Henley

full_name: Angélique Gagné-Henley

given: Angélique

family: Barankin

full_name: Benjamin Barankin

given: Benjamin

family: Lynde

full_name: Charles Lynde

given: Charles

family: Chavda

full_name: Rajeev Chavda

given: Rajeev

family: Kerrouche

full_name: Nabil Kerrouche

given: Nabil

family: Tan

full_name: Jerry Tan

given: Jerry

journal_name: American Journal of Clinical Dermatology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Long-Term Effectiveness and Safety of Up to 48 Weeks’ Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne

ReferenceCitation: Dréno B, Bissonnette R, Gagné-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.

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


title: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

summary: This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

ReferenceCitation: Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, Rezvani AR, Karris NA, McGuirk J, Valcarcel D, Schiller GJ, Lindemans CA, Hwang WYK, Koh LP, Keating A, Khaled Y, Hamerschlak N, Frankfurt O, Peled T, Segalovich I, Blackwell B, Wease S, Freedman LS, Galamidi-Cohen E, Sanz G. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719.

name: Duke University School of Medicine, Durham, North Carolina, United States

family: Horwitz

full_name: Mitchell E Horwitz

given: Mitchell E

name: Loyola University Medical Center, Maywood, Illinois, United States

family: Stiff

full_name: Patrick Joseph Stiff

given: Patrick Joseph

name: Dana Farber Cancer Institute, Boston, Massachusetts, United States

family: Cutler

full_name: Corey S Cutler

given: Corey S

name: University of Minnesota, Minneapolis, Minnesota, United States

family: Brunstein

full_name: Claudio G Brunstein

given: Claudio G

name: Cleveland Clinic, Cleveland, Ohio, United States

family: Hanna

full_name: Rabi Hanna

given: Rabi

name: Oregon Health & Science University School of Medicine, Portland, Oregon, United States

family: Maziarz

full_name: Richard T. Maziarz

given: Richard T.

name: Stanford University, Stanford, California, United States

family: Rezvani

full_name: Andrew R. Rezvani

given: Andrew R.

name: City of Hope National Medical Center, Duarte, California, United States

family: Karras

full_name: Nicole Amalia Karras

given: Nicole Amalia

name: University of Kansas Medical Center, Westwood, Kansas, United States

family: McGuirk

full_name: Joseph P McGuirk

given: Joseph P

name: University Hospital Vall d'Hebron, Barcelona, Spain

family: Valcarcel

full_name: David Valcarcel

given: David

name: David Geffen School of Medicine at UCLA, Los Angeles, California, United States

family: Schiller

full_name: Gary John Schiller

given: Gary John

name: Prinses maxima Center and University Medical Center Utrecht, Utrecht, Netherlands

family: Lindemans

full_name: Caroline A. Lindemans

given: Caroline A.

name: National University Cancer Institute, National University Health System, Singapore

family: Hwang

full_name: William YK Hwang

given: William YK

family: Koh

full_name: Liang-Piu Koh

given: Liang-Piu

name: Childrens Hospital Colorado, United States

family: Keating

full_name: Amy K Keating

given: Amy K

name: Methodist University Hospital, Memphis, Tennessee, United States

family: Khaled

full_name: Yasser Khaled

given: Yasser

name: Hospital Israelita Albert Einstein, São Paulo, Brazil

family: Hamerschlak

full_name: Nelson Hamerschlak

given: Nelson

name: Northwestern University, Chicago, Illinois, United States

family: Frankfurt

full_name: Olga Frankfurt

given: Olga

family: Peled

full_name: Tony Peled

given: Tony

family: Segalovich

full_name: Irit Segalovich

given: Irit

name: Emmes Corporation, Rockville, Maryland, United States

family: Blackwell

full_name: Beth Blackwell

given: Beth

name: The EMMES Corporation, Olney, Maryland, United States

family: Wease

full_name: Stephen Wease

given: Stephen

name: Gertner Institute for Epidemiology and Health Policy Research

family: Freedman

full_name: Laurence S Freedman

given: Laurence S

family: Galamidi-Cohen

name: Hospital Universitario y Politécnico La Fe, Valencia, Spain and CIBERONC, Instituto de Salud Carlos III, Madrid, Spain, Valencia, Spain

title: Omidubicel Versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized Study

ReferenceCitation: Del Pozo Martín Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31.

title: 47th Annual Meeting of the EBMT

location_country:
Italy
Brazil
Netherlands
Spain
France
Israel
Singapore
Portugal
United States
United Kingdom

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

location_facility: The University of Maryland Medicine Center

location_facility: Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center

location_facility: Hospital Universitario y Politécnico La Fe (pediatric)

location_facility: Prinses Maxima Centrum voor Kinderoncologie B.V.

location_facility: Loyola University, Cardinal Bernardin Cancer Center

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Manchester University NHS Foundation Trust

location_facility: Hospital Universitari Vall d'Hebron pediatrics

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil


ReferenceCitation: Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N, Cherukuri A, Jayaram K, Jeha GS, Larimore K, Chan ML, Huntsman Labed A, Day J, Hoover-Fong J. C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia. N Engl J Med. 2019 Jul 4;381(1):25-35. doi: 10.1056/NEJMoa1813446. Epub 2019 Jun 18.

name: From Murdoch Children’s Research Institute, Royal Children’s Hospital, University of Melbourne, Parkville, VIC, Australia (R.S.); Guy’s and St. Thomas’ NHS Foundation Trust, Evelina Children’s Hospital, London (M.I.); Baylor College of Medicine, Houston (C.A.B., B.B.); Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago (J.C.); the Medical Genetics Department, Université Paris Descartes–Sorbonne Paris Cité, INSERM Unité Mixte de Recherche 1163, Institute Imagine, Assistance Publique–Hôpitaux...

family: Savarirayan

full_name: Ravi Savarirayan

given: Ravi

family: Irving

full_name: Melita Irving

given: Melita

family: Bacino

full_name: Carlos A. Bacino

given: Carlos A.

family: Bostwick

full_name: Bret Bostwick

given: Bret

family: Charrow

full_name: Joel Charrow

given: Joel

family: Cormier-Daire

full_name: Valerie Cormier-Daire

given: Valerie

family: Le Quan Sang

full_name: Kim-Hanh Le Quan Sang

given: Kim-Hanh

family: Dickson

full_name: Patricia Dickson

given: Patricia

family: Harmatz

full_name: Paul Harmatz

given: Paul

family: Phillips

full_name: John Phillips

given: John

family: Owen

full_name: Natalie Owen

given: Natalie

family: Cherukuri

full_name: Anu Cherukuri

given: Anu

family: Jayaram

full_name: Kala Jayaram

given: Kala

family: Jeha

full_name: George S. Jeha

given: George S.

family: Larimore

full_name: Kevin Larimore

given: Kevin

family: Chan

full_name: Ming-Liang Chan

given: Ming-Liang

family: Huntsman Labed

full_name: Alice Huntsman Labed

given: Alice

family: Day

full_name: Jonathan Day

given: Jonathan

family: Hoover-Fong

full_name: Julie Hoover-Fong

given: Julie

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: BioMarin Pharmaceutical

location_country:
United States
United Kingdom
Australia
France

acronym: ACH

location_facility: Ann and Robert H. Lurie Childrens Hospital of Chicago

location_facility: Guys & St. Thomas NHS Foundation Trust Evelina Hospital

location_facility: Children's Hospital & Research Center Oakland

location_facility: Johns Hopkins McKusick - Institute of Genetic Medicine

title: A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia

summary: This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.


ReferenceCitation: Müller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nüesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2.

family: Müller

full_name: Volkmar Müller

given: Volkmar

family: Clemens

full_name: Michael Clemens

given: Michael

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Al-Sakaff

full_name: Nedal Al-Sakaff

given: Nedal

family: Auclair

full_name: Petra Auclair

given: Petra

family: Nüesch

full_name: Eveline Nüesch

given: Eveline

family: Holloway

full_name: Debbie Holloway

given: Debbie

family: Shing

full_name: Mona Shing

given: Mona

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Seoul National University - Seoul National University Open Repository

location_country:
Guatemala
Serbia
Spain
France
Panama
Poland
Israel
Hungary
Belgium
Australia
New Zealand
China
Russian Federation
Germany
United Kingdom
Korea, Republic of
Portugal

title: A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors

summary: This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.