acronym: Pembrolizumab (MK-3475) as First-Line Therapy for Advanced Merkel Cell Carcinoma

lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

location_facility: Melanoma Institute Australia ( Site 0400)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0201)

location_facility: Hopital de la Cote de Nacre - Caen ( Site 0204)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0224)

location_facility: Hospital General Universitario de Valencia ( Site 0262)

location_facility: C.H.R.U. de Tours. Hopital Trousseau ( Site 0202)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: Hospital Clinic de Barcelona ( Site 0261)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0282)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 0281)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0203)

location_facility: IEO Istituto Europeo di Oncologia ( Site 0223)

location_facility: Hospital Universitario La Paz ( Site 0263)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0222)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0004)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0200)

location_facility: Hospital Universitari Vall d Hebron ( Site 0264)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

title: A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)

location_country:
Italy
New Zealand
Australia
Sweden
United States
Spain
Canada
France


study_start_date_type: Actual

acronym: JUVE-BASIS

intervention_type: Drug

lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Charité Universitätsmedizin Berlin Campus Buch

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Tokyo Women's Medical University Hospital

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Niigata University Medical & Dental Hospital

location_facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Beijing Children's hospital, Capital Medical University

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Universidade Federal de São Paulo - Escola Paulista de Medicina

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Capitol Institute of Pediatrics Children'S Hospital

location_facility: Children's Hospital of Soochow University

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

status: Completed

title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
France
Denmark
India
Belgium
China
Italy
United Kingdom
Austria
Mexico
Spain
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study

acronym: IWOT

summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.

status: Terminated

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

collaborators: Cooperative Trials Group for Neuro-Oncology (COGNO)

location_country:
Italy
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Aarhus University Hospitals - Aarhus University Hospital-Skejby

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge NHS -Wirral

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Westmead Hospital - Crown Princess Mary Cancer Centre

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

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: ETZ Tilburg - St. Elisabethziekenhuis TweeSteden

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Illawarra Cancer Care Centre - Wollongong Hospital

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove

location_facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)

location_facility: Princess Alexandra Hospital - University of Queensland

status_simplified: Unknown


acronym: ECZTRA 7

lead_sponsor: LEO Pharma

summary:
Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

location_country:
Germany
Poland
United Kingdom
Belgium
Spain
Czechia
France


acronym: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1)

lead_sponsor: Incyte Corporation

summary: The purpose of this study is to assess the efficacy and safety of twice daily ruxolitinib cream in adolescents and adults with Atopic Dermatitis (AD).

ReferenceType: derived

ReferenceCitation: Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, Augustin M, Migliaccio-Walle K, Sullivan SD. Impact of Ruxolitinib Cream on Work Productivity and Activity Impairment and Associated Indirect Costs in Patients with Atopic Dermatitis: Pooled Results From Two Phase III Studies. Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.

repositories_concat: PubMed Central

ReferenceCitation: Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

location_facility: Clinical Research Institute Of Southern Oregon - Crisor

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

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Gyula

location_facility: Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

location_facility: Medycyna Kliniczna Marzena Waszczak-Jeka

location_facility: Well Pharma Medical Research Corporation

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Dawes Fretzin Clinical Research Group LLC

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Budapest

title: A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

location_country:
Germany
Italy
Poland
Hungary
United States
Canada
France

ipd_sharing: No


title: A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

acronym: PROPEL

summary: This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

ReferenceCitation: Schoser B, Roberts M, Byrne BJ, Sitaraman S, Jiang H, Laforet P, Toscano A, Castelli J, Diaz-Manera J, Goldman M, van der Ploeg AT, Bratkovic D, Kuchipudi S, Mozaffar T, Kishnani PS; PROPEL Study Group. Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial. Lancet Neurol. 2021 Dec;20(12):1027-1037. doi: 10.1016/S1474-4422(21)00331-8. Erratum In: Lancet Neurol. 2023 Oct;22(10):e11.

oa_host_type: closed

lead_sponsor: Amicus Therapeutics

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Bosnia and Herzegovina
Canada
France
Slovenia
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Sweden

location_facility: National Center of Neurology and Psychiatry

location_facility: Indiana University Health Neuroscience Center

location_facility: The Feinstein Institute for Medical Research

location_facility: Semmelweis University, Institute of Genomic Medicine and Rare Disease

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Rigshospitalet Copenhagen Neuromuscular Center

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: The Ohio State University Wexner Medical Center

location_facility: Heritage Medical Research Clinic, University of Calgary

location_facility: Washington University School of Medicine

location_facility: UF Helath: University of Florida Clinical Research Center

location_facility: University of South Florida Research Center

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Utah, Center for Clinical and Translational Sciences

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Texas Health Science Center San Antonio

location_facility: University of Minnesota Clinical Research Unit


title: Personalized CRT - Product Surveillance Registry (PSR)

summary: The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
United States
Korea, Republic of
Spain
Malaysia
Canada
Serbia
France

intervention_type: Device


title: SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype

acronym: SOLAR

summary:
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

ReferenceCitation: Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Brunel University London - Brunel University Research Archive (BURA)

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: miRagen Therapeutics, Inc.

location_country:
Italy
United Kingdom
Australia
Belgium
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Chao Family Comprehensive Cancer Center at University of California, Irvine

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: AOU Citta dell Salute e della Scienza di Torino

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico


title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.

evidence: open (via page says license)

repository_institution: University of Tsukuba - Terrestrial Environment Research Center

publisher_dissemination: Future Science Ltd

location_country:
Finland
Germany
Poland
Australia
Brazil
Costa Rica
Japan
Turkey
Canada
France
Colombia
Portugal
Hungary
Switzerland
United States
Belgium
China
Malaysia
Peru
Puerto Rico
Italy
Guatemala
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)

location_facility: Hamamatsu University Hospital ( Site 0416)

location_facility: Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)

location_facility: Henan Cancer Hospital-Urology ( Site 1770)

location_facility: Taipei Veterans General Hospital ( Site 1652)

location_facility: Osaka International Cancer Institute ( Site 0413)

location_facility: University of Vermont Medical Center ( Site 1057)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0357)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)

location_facility: The First Affiliated hospital of Xiamen University-Urology ( Site 1776)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 0604)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)

location_facility: Princess Margaret Cancer Centre ( Site 0153)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)

location_facility: Policlinico Universitario A. Gemelli ( Site 0358)

location_facility: University Hospital of Larissa ( Site 0301)

location_facility: University of California Irvine Medical Center ( Site 1061)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1059)

location_facility: Northwestern Memorial Hospital ( Site 1101)

location_facility: Hemato Oncologos SA-Oncology ( Site 1601)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)

location_facility: Mayo Clinic in Arizona - Phoenix ( Site 1094)

location_facility: Universitaetsklinik Salzburg ( Site 0053)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0265)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0409)

location_facility: Hospital São Carlos-Oncocentro Ce ( Site 1558)

location_facility: China Medical University Hospital-Department of Urology ( Site 1654)

location_facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8003)

location_facility: TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)

location_facility: Exdeo Clinical Research Inc. ( Site 0165)

location_facility: The Second Hospital of Tianjin Medical University ( Site 1769)

location_facility: MD Anderson Cancer Center Madrid ( Site 0859)

location_facility: Advance Urology and Laparoscopic Center ( Site 0757)

location_facility: Urology Clinics of North Texas, PLLC ( Site 1064)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)

location_facility: Urology San Antonio Research ( Site 1108)

location_facility: Nara Medical University Hospital ( Site 0411)

location_facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)

location_facility: Harbin Medical University Cancer Hospital-urology ( Site 1772)

location_facility: Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)

location_facility: Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)

location_facility: University of Tsukuba Hospital ( Site 0412)

location_facility: Associated Medical Professionals of NY ( Site 1078)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)

location_facility: Mayo Clinic in Florida-Urology ( Site 1097)

location_facility: Hirosaki University Hospital ( Site 0407)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)

location_facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)

location_facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)

location_facility: Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)

location_facility: Osaka Metropolitan University Hospital ( Site 0404)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 1087)

location_facility: Carolina Urologic Research Center ( Site 1085)

location_facility: OHSU Knight Cancer Institute ( Site 1075)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)

location_facility: Instituto de Cancerología-Oncology ( Site 1609)

location_facility: General University Hospital of Patras ( Site 0302)

location_facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)

location_facility: Stavanger universitetssykehus ( Site 0555)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0857)

location_facility: Urology Associates [Nashville, TN] ( Site 1072)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)

location_facility: Zhejiang Provincial People's Hospital-Urology ( Site 1762)

location_facility: Medical Concierge Centrum Medyczne ( Site 0676)

location_facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)

location_facility: Peking University First Hospital ( Site 1759)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0653)

location_facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)

location_facility: Kitasato University Hospital ( Site 0403)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)

location_facility: UZA University Hospital Antwerp ( Site 0105)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 0679)

location_facility: Medizinische Universität Wien ( Site 0054)

location_facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)

location_facility: Oncomedica S.A.-Oncomedica S.A ( Site 1604)

location_facility: Hospital Universitario La Paz ( Site 0866)

location_facility: Clinical Research Center Sp. z o.o. ( Site 0674)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)

location_facility: CHU UCL Namur Site de Godinne ( Site 0103)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)

location_facility: Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)

location_facility: West China Hospital Sichuan University ( Site 1767)

location_facility: University Hospitals Cleveland Medical Center ( Site 1066)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)

location_facility: Osp Generale Reg di Bolzano ( Site 0355)

location_facility: University Malaya Medical Centre ( Site 1180)

location_facility: Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0860)

location_facility: Maastricht University Medical Centre ( Site 0453)

location_facility: Taichung Veterans General Hospital ( Site 1653)

location_facility: Tampere University Hospital [Tampere Finland] ( Site 0201)

location_facility: Hospital Universitario Lucus Augusti ( Site 0852)

location_facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)

location_facility: Urological Research Network ( Site 1106)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)

location_facility: University Of Texas Southwestern Medical Center ( Site 1053)

location_facility: Beijing Cancer hospital-Urinary Surgery ( Site 1755)

location_facility: Korea University Anam Hospital ( Site 0801)

location_facility: Akershus University Hospital ( Site 0553)

location_facility: Semmelweis University-Urológiai Klinika ( Site 1301)

location_facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)

location_facility: Clinica Universitaria de Navarra ( Site 0863)

location_facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)

location_facility: Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)

location_facility: 2CA Braga. Centro Clinico Academico ( Site 0705)

location_facility: Hospital Universitario Quiron Madrid ( Site 0862)

location_facility: St. Marianna University Hospital ( Site 0415)

location_facility: Seoul National University Hospital ( Site 0802)

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 1360)

location_facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10

location_facility: Administradora Country S.A. - Clinica del Country ( Site 1607)

location_facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)

location_facility: Hôpital Foch-Urology department ( Site 1351)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0854)

location_facility: Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)

location_facility: Michigan Institute of Urology ( Site 1077)

location_facility: Univ. Klinik f. Urologie Innsbruck ( Site 0051)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)

location_facility: Woodlands Medical Specialists, PA ( Site 8002)

intervention_type: Biological

status_simplified: Ongoing


lead_sponsor: Pfizer

summary: A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).

sponsor_collaborators:
Pfizer
Children's Oncology Group (COG)

location_facility: Intermountain - Primary Children's Hospital

location_facility: Institut nuklearnej a molekularnej mediciny

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

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Children's Healthcare of Atlanta at Scottish Rite

location_facility: Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Buerger Center for Advanced Pediatric Care

location_facility: Children's Healthcare of Atlanta, Medical Office Building

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Primary Children's Hospital Outpatient Services

location_facility: Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital

location_facility: Detska Fakultna nemocnica s poliklinikou Banska Bystrica

location_facility: University Hospitals Cleveland Medical Center

location_facility: Carolinas Medical Center/Levine Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Minnesota Medical Center, Fairview

location_facility: University of Oklahoma Health Sciences Center

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: University of Minnesota Masonic Children's Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: University of Florida College of Medicine

location_facility: University of Alabama at Birmingham/Children's of Alabama

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center

location_facility: Johns Hopkins All Children's Outpatient Care Center

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: Washington University School of Medicine

location_facility: Torrey Hemby Center for Cancer and Blood Disorders

location_facility: University of Minnesota/Masonic Cancer Center

location_facility: Torrence E. Hemby Jr. Pediatric Hematology & Oncology Center

location_facility: University of Illinois College of Medicine at Peoria

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica, Oddelenie radiologie

location_facility: Kapiolani Medical Center for Women and Children

location_facility: University College London Hospital, NHS Foundation Trust

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

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

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Children's Healthcare of Atlanta at Egleston

location_facility: University of Mississippi Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

title: PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

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.

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
India
Belgium
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Bulgaria
Israel


title: Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

acronym: Protect-NOW

summary: International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

time_perspective: Other

lead_sponsor: Octapharma

location_country:
France
Belarus
Germany
Italy
Lithuania
Hungary
United Kingdom
Mexico
Belgium
United States
Spain
Turkey
Canada
Estonia
Russian Federation
Azerbaijan

location_facility: Centre Régional de Traitement de l'hémophilie

location_facility: Department of Hematology Research Research Transition Facility

location_facility: Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia

location_facility: Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain

location_facility: Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

location_facility: Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

location_facility: Hospital Infantil de Morelia Eva Sámano de López Mateos

location_facility: John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

location_facility: CHRU Hopital Nord, Secretariat de pediatre

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

location_facility: Hospital General Universitario de Alicante Hematología y Hemoterapia

location_facility: McMaster University, Division of Pediatric Hematology/Oncology Room 3N27

location_facility: Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology

location_facility: Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

location_facility: University of Debrecen Department of Pediatrics

location_facility: Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

location_facility: Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)

location_facility: Cure 4 The Kids Foundation Children's Specialty Center

location_facility: Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: SMO and Scientific Services S.A.P.P de C.V

location_facility: Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"

location_facility: Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

location_facility: CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez S/N

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Republican Scientific Center for Radiation Medicine and Human Ecology

location_facility: Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital

location_facility: Heim Pál National Pediatric Institute Department of Oncology and Hematology


title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

design_allocation: Non-Randomized

location_country:
Italy
Poland
Hungary
Romania
Austria
United States
Spain
France

location_facility: California Cancer Associates for Research and Excellence, Inc.

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

location_facility: Rocky Mountain Cancer Centers - Denver - Midtown

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Christiana Care Helen F. Graham Cancer Center

location_facility: Texas Oncology Surgical Specialists - Austin Central

location_facility: Clinical Emergency Hospital of Constanta

location_facility: St. Joseph Health Medical Group - Annadel Medical Group

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc.

location_facility: Azienda Ospedaliera Universitaria Senese


lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Centre Henri Becquerel- Centre de Lutte Contre le Cancer

location_facility: Hospital San Pedro de Alcantara; Servicio de Hematología

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of California; Moores Cancer Center

location_facility: University of Miami Miller School of Medicine

location_facility: Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku

title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
Austria
United States
Korea, Republic of
Spain
France


title: A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

summary: To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

lead_sponsor: Impax Laboratories, LLC

location_country:
Germany
Italy
Poland
United Kingdom
United States
Spain
Czechia
France

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

location_facility: Neurology Consultants of Dallas, PA (108)

location_facility: Klinik Haag i. OB, Geriatric Hospital (305)

location_facility: St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)

location_facility: Hospital Genral Universitario de Elche (509)

location_facility: University of Florida Health Science Center(129)

location_facility: University of Arkansas for Medical Sciences (117)

location_facility: Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

location_facility: Hospital Universitario de la Princesa (508)

location_facility: Premiere Research Institute at Palm Beach Neurology (174)

location_facility: VCU Health - Neuroscience, Orthopaedic and Wellness Center (124)

location_facility: Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)

location_facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

location_facility: Christiana Care Neurology Specialists (153)

location_facility: Hospital Universitario Ramon y Cajal (500)

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: Rocky Mountain Movement Disorders Center (116)

location_facility: Henry Ford West Bloomfield Hospital (100)

location_facility: University of Kansas Medical Center (118)

location_facility: Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)

location_facility: University of Miami-UHealth at Boca Raton (152)

location_facility: Booth Gardner Parkinson's Care Center (112)

location_facility: Curiositas ad sanum, Studien und Beratungs GmbH(311)

location_facility: Keck School of Medicine of USC/University of Southern California (106)

location_facility: Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)

location_facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)

location_facility: Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)

location_facility: Medical University of South Carolina (150)

location_facility: Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)

location_facility: University Hospitals Cleveland Medical Center (123)

location_facility: Hospital Universitario y politecnico La Fe (515)

location_facility: Wake Forest Baptist Health Sciences (127)

location_facility: Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)

location_facility: Hoag Memorial Hospital Presbyterian (134)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

location_facility: NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)

location_facility: CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404)

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

location_facility: Medical Professional Clinical Research Center, INC (163)

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)

location_facility: CHU de Montpellier, Hopital Gui de Chauliac(405)

location_facility: Hospital Universitari Mutua Terrassa (506)

location_facility: Indiana University Health Neuroscience Center (164)

location_facility: Parkinsons's Disease Treatment Center of Southwest Florida (131)

location_facility: Mount Sinai West-Department of Neurology(172)

location_facility: Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)

location_facility: Hospital De La Santa Creu i Sant Pau (502)

location_facility: University of Texas Southwestern Medical Center (143)

location_facility: University of Toledo, Gardner-McMaster Parkinson Center (122)

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)

location_facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

location_facility: Hospital Universitario Virgen del Rocio (503)

location_facility: Hospital Universitario Infanta Sofia (513)

location_facility: Northwestern Medical Group Neurology Clinic(145)

location_facility: INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)

location_facility: Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)

location_facility: Hospital Universitario Quiron Dexeus (501)

location_facility: Roseman Medical Research Institute/Roseman Medical Group (154)

location_facility: Loma Linda University Health Care, Department of Neurology (137)

location_facility: Neurologicka ordinace FORBELI s.r.o.(706)

location_facility: Krakowska Akademia Neurologii Sp. z o.o.(802)

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

location_facility: Imperial College Healthcare NHS Trust (200)

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: Movement Disorder Clinic of Oklahoma (115)

location_facility: Hospital Universitario Vall d' Hebron (505)

location_facility: St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)


title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

summary: The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

ReferenceCitation: Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.

ReferenceCitation: MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.

publisher_dissemination: SAGE Publications

ReferenceCitation: Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.

ReferenceCitation: Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.

ReferenceCitation: Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.

ReferenceCitation: Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.

ReferenceCitation: Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.

location_country:
Germany
Italy
India
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Mexico
United States
China
Spain
Switzerland
Czechia
Russian Federation
France

location_facility: Beijing Tiantan Hospital Affiliated to Capital Medical Univ

location_facility: Tianjin Medical University General Hospital

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí S.C.

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: Synexus Midlands Clinical Research Center

location_facility: Affiliated Hospital of Jiangsu University

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: First hospital affiliated to Zhengzhou University

location_facility: Xiangya Hospital, Central South University

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Hospital Universitario La Fe de Valencia

location_facility: The First Affliated Hospital of Suzhou University

location_facility: UCSD Altman Clinical & Translational Research Institute (ACTRI)

location_facility: No.2 Hospital Affiliated to Jilin University

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Centre Hospitalier Annecy Genevois - Site d'Annecy

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Mangala Hospitals & Mangala Kidney Foundation

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: HuaShan Hospital Affiliated To Fudan University

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: No 1 Affiliate Hospital of Kunming Medical College

location_facility: Rehabilitation & Neurological Services LLC

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: George Washington University Medical Center

location_facility: Deenanth Mangeshkar Hospital and Research Centre

location_facility: West China Hospital of Sichuan University

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Gemeinschaftspraxis für Neurologie und Psychiatrie

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Neurologicka ambulance, Neurologie Brno s.r.o.

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: The First Affiliated Hospital of Wenzhou Medical College


title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)

summary: This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

status: Active, not recruiting

lead_sponsor: ISA Pharmaceuticals

sponsor_collaborators:
ISA Pharmaceuticals
Regeneron Pharmaceuticals

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Brazil
Netherlands
Mexico
Belgium
United States
Spain
Czechia
France

location_facility: National Cancer Institute Regina Elena, IRCCS

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO

location_facility: Robert H. Lurie Comprehensive Cancer Center

location_facility: University of Cincinnati Cancer Institute

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: Azienda Ospedaliera San Paolo Polo Universitario

location_facility: Washington University School of Medicine

location_facility: Maria Sklodowska-Curie National Institute of Oncology

location_facility: Hospital Universitario Marqués de Valdecilla Santander

location_facility: ASST Spedali Civili Brescia, Department of Medical Oncology

location_facility: Hopitaux Universitaires Pitié Salpêtrière Charles Foix

location_facility: University of Pecs Department of Oncotherapy

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz


acronym: CheckMate 848

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

location_facility:
Local Institution - 0075
Local Institution - 0119
Rocky Mountain Cancer Centers
Local Institution - 0082
Local Institution - 0029
Local Institution - 0031
Local Institution - 0084
Local Institution - 0018
Fundacion De Investigacion
Duke Cancer Institute
Local Institution - 0071
Local Institution - 0083
Local Institution - 0117
John Wayne Cancer Center
Local Institution - 0077
Local Institution - 0067
Broome Oncology
Local Institution - 0081
Local Institution - 0072
Local Institution - 0113
Local Institution - 0080
Local Institution - 0015
Local Institution - 0002
Local Institution - 0090
Local Institution - 0070
Local Institution - 0095
Local Institution - 0039
Local Institution - 0032
Local Institution - 0069
Local Institution - 0073
Local Institution - 0043
Local Institution - 0016
Local Institution - 0118
Local Institution - 0068
Texas Oncology - Northeast Texas
Local Institution - 0062
Local Institution - 0076
Local Institution - 0001
Local Institution - 0116
Local Institution - 0106
Local Institution - 0107
Local Institution - 0094
Local Institution - 0114
Local Institution - 0085
Local Institution - 0086
IRCCS Istituto Nazionale Tumori Milano
Local Institution - 0065
Local Institution - 0078
Local Institution - 0115
Local Institution - 0079
Local Institution - 0074
Local Institution - 0010
Local Institution - 0066
Local Institution - 0060
Local Institution - 0093
Local Institution - 0087
Local Institution - 0110
Local Institution - 0036
Local Institution - 0112
Local Institution - 0088

title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Denmark
Australia
Romania
Netherlands
Singapore
Belgium
United States
Spain
Chile
Canada
Puerto Rico
France


acronym: MAPIT

intervention_type: Other

lead_sponsor: ALK-Abelló A/S

summary: The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

location_facility: Respiratory Medicine Research Institute of MI

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Uniwersytecki Szpital Dzieciecy w Lublinie

location_facility: Hospital Regional Universitario de Málaga

location_facility: Groupe hospitalier Armand Trousseau - La Roche Guyon

location_facility: Clinical and Diagnostic Centre "Zdorovie"

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: GBUZ "Children Municipal Polyclinic #45"

location_facility: GBUZ "Samarskiy oblastnoy detskiy sanatoriy "Yunost" 9-proseka

location_facility: Royal Manchester Children's Hospital - Paediatrics Oxford Road

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: ALERGOTEST s.c. Specjalistyczne Centrum Medyczne

title: A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma

location_country:
Germany
Poland
Hungary
United Kingdom
United States
Spain
Bulgaria
Russian Federation
France


title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

acronym: MIRCAST

summary:
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

Robotic Right Colectomy with ICA
Robotic Right Colectomy with ECA
Laparoscopic Right Colectomy with ICA
Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

status: Unknown status

ReferenceCitation: Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gogenur I, Jayne D, Khan JS, Rautio T, Sanchez-Guillen L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.

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

repository_institution: University of Oulu - University of Oulu Repository - Jultika

repositories_concat: PubMed Central;air.unimi.it;oulu.fi

lead_sponsor: Instituto de Investigación Marqués de Valdecilla

location_country:
Finland
Germany
Italy
Portugal
United Kingdom
Denmark
Spain
Greece
Croatia
France

location_facility: ICM - Institut Régional du Cancer de Montpellier

intervention_type: Procedure


acronym: Trial of 1L Pembrolizumab Plus Chemotherapy in Persistent, Recurrent, or Metastatic Cervical Cancer

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).

ReferenceCitation: Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

publisher_dissemination: Massachusetts Medical Society

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 1009)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)

location_facility: Policlinico Universitario -Agostino Gemelli ( Site 1241)

location_facility: West Cancer Center - East Campus ( Site 1763)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1360)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

location_facility: MD Anderson Cancer Center Madrid ( Site 1273)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)

location_facility: Keimyung University Dongsan Medical Center ( Site 1603)

location_facility: Saitama Medical University International Medical Center ( Site 1691)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 1367)

location_facility: University of the Ryukyus Hospital ( Site 1706)

location_facility: St John of God Subiaco Hospital ( Site 1512)

location_facility: Medical Care and Research S.A. de C.V. ( Site 1135)

location_facility: Universitatsklinikum Essen AoR ( Site 1213)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 1731)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1484)

location_facility: National Research Ogarev Mordovia State University ( Site 1347)

location_facility: The Ottawa Hospital Cancer Centre ( Site 1736)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)

location_facility: Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

location_facility: Centro Oncologico Riojano Integral ( Site 1004)

location_facility: Sunnybrook Research Institute ( Site 1733)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

location_facility: Hospital Universitario Virgen Macarena ( Site 1274)

location_facility: London Regional Cancer Program - London HSC ( Site 1723)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)

location_facility: Taichung Veterans General Hospital ( Site 1634)

location_facility: National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)

location_facility: Taipei Veterans General Hospital ( Site 1631)

location_facility: Universitaetsklinikum Duesseldorf ( Site 1220)

location_facility: Hospital de Oncologia Angel Roffo ( Site 1003)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)

location_facility: Princess Margaret Cancer Centre ( Site 1732)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1211)

location_facility: The Jikei University Hospital ( Site 1697)

location_facility: Seoul National University Hospital ( Site 1602)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 1159)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)

location_facility: National Cancer Center Hospital ( Site 1702)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 1451)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1095)

location_facility: National Cancer Center Hospital East ( Site 1704)

location_facility: Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)

location_facility: The Jikei University Kashiwa Hospital ( Site 1701)

location_facility: Centro Medico Monte Carmelo ( Site 1156)

location_facility: Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

location_facility: Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

location_facility: Municipal Clinical Oncology Center ( Site 1346)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1785)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 1453)

location_facility: Instituto Nacional de Cancerologia. ( Site 1130)

location_facility: Hospital Nacional Maria Auxiliadora ( Site 1155)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1633)

location_facility: China Medical University Hospital ( Site 1635)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 1097)

location_facility: Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

location_facility: Hacettepe University Medical Faculty ( Site 1459)

location_facility: Istituto Europeo di Oncologia ( Site 1250)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)

location_facility: Medical Rehabilitation Center ( Site 1337)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8001)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1487)

location_facility: Georgia Cancer Center at Augusta University ( Site 1767)

location_facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)

location_facility: Iwate Medical University Hospital ( Site 1695)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1698)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 1809)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

location_facility: MUSC Hollings Cancer Center ( Site 1819)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 1061)

location_facility: Kaohsiung Veterans General Hospital ( Site 1632)

location_facility: BC Cancer - Vancouver Center ( Site 1722)

location_facility: Instituto Clinico Oncologico del Sur ( Site 1062)

location_facility: MI Odessa Regional Oncological Centre ( Site 1493)

location_facility: Monash Health-Monash Medical Centre ( Site 1519)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)

location_facility: Shaare Zedek Medical Center ( Site 1366)

location_facility: Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 8005)

location_facility: Medical Centre LLC Oncolife ( Site 1485)

location_facility: Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

location_facility: Washington University School of Medicine ( Site 1779)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 1700)

location_facility: City Clinical Hosp.4 of DCC ( Site 1482)

location_facility: Seattle Cancer Care Alliance ( Site 1777)

location_facility: Cancer Institute of New Jersey at University Hospital ( Site 1762)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

location_facility: Columbia University Medical Center ( Site 1800)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 1185)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

type: Registry Identifier

location_country:
Germany
Argentina
Australia
Japan
Turkey
Chile
Canada
France
Colombia
United States
Ukraine
Peru
Italy
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


lead_sponsor: Novartis Pharmaceuticals

summary:
This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

location_facility: USC Kenneth Norris Comprehensive Cancer Center Pharmacy Contact

title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Iceland
India
Romania
Lebanon
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


summary: This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

location_facility: Huntsman Cancer Institute Univ of Utah .

location_facility: Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory

location_facility: University of Cincinnati Cancer Institute

location_facility: Montefiore Medical Center Albert Einstein College of Med

title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

location_country:
Germany
Poland
Taiwan
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Hungary
Denmark
United States
Lebanon
Belgium
China
Italy
Singapore
Netherlands
Korea, Republic of
Spain
Greece
Jordan
Russian Federation
Israel


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

acronym: BRAVE II

summary: The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_country:
Italy
Poland
Colombia
India
Argentina
Romania
Japan
United States
Korea, Republic of
Spain
South Africa
Chile
Serbia
Philippines
France

location_facility: Glacier View Research Institute - Endocrinology

location_facility: Centro Integral de Reumatologia e Inmunologia

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Angeles University Foundation and Medical Center

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Aprillus Asistencia e Investigacion - Servicio de neurologia

location_facility: NHL Municipal Medical College & VS General Hospital

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Sociedad Medica Del Aparato Locomotor SA

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Seoul National University Bundang Hospital

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

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Johns Hopkins University School of Medicine

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Comite de Etica en Investigacion - CEMIC

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

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

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: University of Occupational and Enviromental Health

location_facility: Craiova Emergency Clinical County Hospital

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej


title: A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

acronym: SIDEROS-E

summary: The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

ReferenceType: background

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

ReferenceCitation: Mayer OH, Leinonen M, Rummey C, Meier T, Buyse GM; DELOS Study Group. Efficacy of Idebenone to Preserve Respiratory Function above Clinically Meaningful Thresholds for Forced Vital Capacity (FVC) in Patients with Duchenne Muscular Dystrophy. J Neuromuscul Dis. 2017;4(3):189-198. doi: 10.3233/JND-170245.

lead_sponsor: Santhera Pharmaceuticals

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

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: University of Alabama - Birmingham, Child Health Research

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: Children's Hospital Boston, Harvard Medical School, Department of Neurology

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: U.O. Malattie Neuromuscolari, Istituto Giannina Gaslini

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: University Medical Center Hamburg - Eppendorf, Department of Paediatrics

location_facility: Gillette Children's Specialty Healthcare

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Clinical Research Facility Level 6 Leazes Wing Royal Victoria Infirmary

location_facility: Great Ormond Street Hospital for Children

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, 2ème étage

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Hospital Sant Joan de Deu Neuropediatra, Unidad de patologia nueromuscular, Servicio de Neurologia

location_facility: Children's Hospital of Philadelphia, Division of Pulmonology

location_facility: Center for neuromuscular disorders, Dr. v. Haunersche Kinderklinik, Universität München

location_facility: Hospital La Fe de Valencia Avinguda de Fernando Abril Martorell Servicio de Neurologia Torre D

location_facility: Servizio di Cardiomiologia e Genetica Medica AOU Università degli Studi della Campania Luigi Vanvitelli

location_facility: Hôpital des enfants, Pédiatrie Neurologie et infectiologie Pôle enfants

location_facility: Scientific Coordinator Nemo Sud Clinical CenterAOU Policlinico "G. Martino"

location_facility: Hôpital Hôtel Dieu, Service Explorations Fonctionnelles - Centre de Référence de Maladies Neuromusculaires rares

location_facility: Banner University of Arizona Medical Center

location_facility: Center for Integrative Rare Disease Research, Rare Disease Research, LLC

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Eta Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac, Département de pédiatrie - neuropédiatrie

location_facility: University of Iowa, Department of Pediatrics

location_facility: UCL, National Hospital for Neurology and Neurosurgery


summary:
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

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

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Croatia
Czechia
Canada
France
Colombia
Hungary
Denmark
United States
India
Malaysia
Peru
Oman
Puerto Rico
Guatemala
Singapore
Austria
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden


summary:
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Vietnam
Chile
France
Slovakia
United States
India
Romania
Tunisia
Lebanon
Belgium
Estonia
Philippines
Italy
United Kingdom
Netherlands
Mexico
Spain
Taiwan
Russian Federation
Israel


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

acronym: SPIRIT

summary: The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.

ReferenceCitation: Raghu G, Mouded M, Chambers DC, Martinez FJ, Richeldi L, Lancaster LH, Hamblin MJ, Gibson KF, Rosas IO, Prasse A, Zhao G, Serenko M, Novikov N, McCurley A, Bansal P, Stebbins C, Arefayene M, Ibebunjo S, Violette SM, Gallagher D, Behr J. A Phase IIb Randomized Clinical Study of an Anti-alphavbeta6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Nov 1;206(9):1128-1139. doi: 10.1164/rccm.202112-2824OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Shenderov K, Collins SL, Powell JD, Horton MR. Immune dysregulation as a driver of idiopathic pulmonary fibrosis. J Clin Invest. 2021 Jan 19;131(2):e143226. doi: 10.1172/JCI143226.

evidence: open (via free pdf)

publisher_dissemination: American Society for Clinical Investigation

lead_sponsor: Biogen

location_country:
Italy
Poland
Israel
Argentina
Denmark
Australia
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Chile
Czechia
Russian Federation
France

location_facility:
Research Site
Reserach Site