title: A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)

acronym: CIPHER

summary: The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

primary_purpose: Diagnostic

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
United Kingdom
Netherlands
Ukraine
United States
France
Belgium
Germany

location_facility: SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: University Of Colorado Cardiac And Vascular Center

location_facility: National Waiting Times Centre Board Golden Jubilee National Hospital

location_facility: The Houston Methodist Research Institute

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I


ipd_sharing: Yes

status: Recruiting

primary_purpose: Treatment

acronym: NATRON

intervention_type: Biological

title: A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

study_completion_date_type: Anticipated

lead_sponsor: AstraZeneca

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

enrollment_type: Anticipated

location_country:
Denmark
Poland
Italy
Austria
Netherlands
Switzerland
United States
France
Israel
Belgium
Japan
Germany

summary: This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase 3 study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. Patients will not continue to be recruited after 47 patients have had their first HES worsening/flare.The primary database lock (DBL) will occur when at least 47 patients have had their first HES worsening/flare event and all randomised patients have been followed up for the 24-week DB treatment period. The target patient population is male and female patients 12 years of age and older with symptomatic active HES. Approximately 120 eligible patients will be randomised at a 1:1 ratio to receive either benralizumab or matching placebo

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
United Kingdom
Mexico
Netherlands
Argentina
United States
France
Belgium
Germany

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Medvin Clinical Research - Covina Office

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Arthritis and Osteoporosis Center - Orangeburg

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Henry Ford Medical Center - New Center One

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Nasz Lekarz Osrodek Badan Klinicznych - Torun

location_facility: Arizona Arthritis and Rheumatology Research

location_facility: Clinical Research of West Florida - Clearwater

location_facility: Inland Rheumatology and Osteoporosis Medical Group

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: North Georgia Rheumatology Group-Lawrenceville

location_facility: Arthritis and Rheumatology Institute - Plano Location

location_facility: Clinical Investigation Specialists - Gurnee

summary: The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).


status: Active, not recruiting

acronym: CUPID

title: Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

lead_sponsor: Sanofi

type: Registry Identifier

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

location_country:
Spain
United Kingdom
Russian Federation
Argentina
Canada
Hungary
United States
France
China
Japan
Germany

location_facility:
Investigational Site Number :3920010
Investigational Site Number :6430005
Investigational Site Number :6430001
Investigational Site Number :8400009
Investigational Site Number :1240005
Investigational Site Number :7240008
Investigational Site Number :8400014
Investigational Site Number :2500005
Investigational Site Number :6430004
Investigational Site Number :2500006
Investigational Site Number :8400010
Investigational Site Number :7240007
Investigational Site Number :3920005
Investigational Site Number :2760007
Investigational Site Number :3920007
Investigational Site Number :3480004
Investigational Site Number :1560004
Investigational Site Number :7240003
Investigational Site Number :7240009
Investigational Site Number :1560003
Investigational Site Number :8400001
Investigational Site Number :1560005
Investigational Site Number :2500003
Investigational Site Number :7240005
Investigational Site Number :1240004
Investigational Site Number :3920003
Investigational Site Number :8400007
Investigational Site Number :7240002
Investigational Site Number :0320003
Investigational Site Number :8400006
Investigational Site Number :0320007
Investigational Site Number :0320008
Investigational Site Number :1560007
Investigational Site Number :8400018
Investigational Site Number :8400017
Investigational Site Number :1240006
Investigational Site Number :0320004
Investigational Site Number :3480002
Investigational Site Number :2500002
Investigational Site Number :3920008
Investigational Site Number :2760001
Investigational Site Number :8260001
Investigational Site Number :8400016
Investigational Site Number :1560008
Investigational Site Number :8400015
Investigational Site Number :1560002
Investigational Site Number :3480003
Investigational Site Number :6430010
Investigational Site Number :8400011
Investigational Site Number :0320006
Investigational Site Number :2760006
Investigational Site Number :3920001
Investigational Site Number :6430009
Investigational Site Number :0320005
Investigational Site Number :7240006
Investigational Site Number :6430003
Investigational Site Number :6430006
Investigational Site Number :7240001
Investigational Site Number :1240002
Investigational Site Number :3920004
Investigational Site Number :6430007
Investigational Site Number :8400019
Investigational Site Number :2500004
Investigational Site Number :1240009
Investigational Site Number :1240010
Investigational Site Number :8400003
Investigational Site Number :3920002
Investigational Site Number :7240004
Investigational Site Number :1560001
Investigational Site Number :8400008
Investigational Site Number :1560006
Investigational Site Number :6430008
Investigational Site Number :3480005
Investigational Site Number :8260002
Investigational Site Number :0320001
Investigational Site Number :6430002
Investigational Site Number :3920006
Investigational Site Number :8400020
Investigational Site Number :1240007

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)

Secondary Objectives:

To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab


title: A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

acronym: BANFF

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

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).

lead_sponsor: Genentech, Inc.

location_country:
Spain
Puerto Rico
United States
France
Belgium

location_facility: National Research Institute - Panorama City

location_facility: Consorci Hospital General Universitari de València

location_facility: Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Duke Medical Center; Gen Clinic Research Ctr

location_facility: Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)

location_facility: Hôpital d'Enfants, Service d'onco-hématologie pédiatrique

location_facility: Hunter Holmes McGuire V.A. Medical Center

location_facility: Pinnacle Clinical Research - San Antonio

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Texas Digetive Disease Consultants - Austin

location_facility: UC San Diego Airway Research and Clinical Trials Center

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica


title: Safety Study of Oral Edaravone Administered in Subjects With ALS

summary: The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

location_country:
Italy
Canada
United States
France
Japan
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: National Hospital Organization Chiba-East-Hospital

location_facility: National Hospital Organization Iou National Hospital

location_facility: University of Michigan - ALS Center of Excellence

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Heritage Medical Research Clinic - University Of Calgary

location_facility: University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: National Hospital Organization Utano Hospital

location_facility: CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Shiga University of Medical Science Hospital

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: Niigata University Medical And Dental Hospital

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Houston Methodist Neurological Institute

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

status_simplified: Completed


ipd_sharing: No

status: Terminated

title: A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

lead_sponsor: NuCana plc

ReferenceType: derived

ReferenceCitation: McNamara MG, Goyal L, Doherty M, Springfeld C, Cosgrove D, Sjoquist KM, Park JO, Verdaguer H, Braconi C, Ross PJ, Gramont A, Zalcberg JR, Palmer DH, Valle JW, Knox JJ. NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). Future Oncol. 2020 Jun;16(16):1069-1081. doi: 10.2217/fon-2020-0247. Epub 2020 May 6.

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Turkey
Germany
Czechia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: SI "Shalimov's National Institute of Surgery and Transplantation" of NAMSU

location_facility: University of Rochester Medical Center - Strong Memorial Hospital

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Northwest Cancer Specialists, P.C.-Vancouver

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Hospital Universitario Clinico San Carlos

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Baskent University Adana Application and Research Center

location_facility: Centro Ricerche Cliniche di Verona S.r.l

location_facility: CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

location_facility: Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Communal Institution Odesa Regional Clinical Hospital

location_facility: MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Seoul National University Bundang Hospital

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Rocky Mountain Cancer Centers, LLP- Aurora

location_facility: CHA Bundang Medical Center, CHA University

location_facility: State Budget Institution of Healthcare "Leningrad Regional Clinical Oncology Dispensary"

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: The Research Foundation for The State University of New York

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

summary:
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

status_simplified: Unknown


title: A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

acronym: ORCHID

summary: This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

location_country:
Poland
Taiwan
Italy
Russian Federation
Australia
Argentina
Thailand
Vietnam
Hungary
United States
Chile
China
France
Belgium
Japan
Sweden
Turkey
Bulgaria


title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

lead_sponsor: Eli Lilly and Company

type: Other Identifier

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.

location_country:
Poland
Spain
Latvia
Estonia
Australia
Canada
Lithuania
Korea, Republic of
United States
France

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

location_facility: Sant Joan de Deu Serveis En Salut Mental

location_facility: California Dermatology & Clinical Research Institute

location_facility: Smite Aija - Practice in Dermatology Venereology

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Soon Chun Hyang University Seoul Hospital

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

location_facility: Vital Prospects Clinical Research Institute, P.C.

summary: This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


title: A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)

acronym: M-PLACE

summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

lead_sponsor: MorphoSys AG

location_country:
Poland
Spain
Italy
Australia
Korea, Republic of
United States
France
Belgium
Netherlands

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital General Universitario de Valencia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: University of Miami Division of Nephrology & Hypertension

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Kidney Care and Transplant Services of New England, PC

location_facility: The Ohio State University Wexner Medical Center

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin


title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease

summary: This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

lead_sponsor: Amicus Therapeutics

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

location_facility: Washington University School of Medicine

location_facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc.

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: University of Arkansas for Medical Sciences

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: University of Florida Clinical Research Center

location_facility: UPMC Montefiore Clinical and Translational Research Center

location_facility: University of Cincinnati Gardner Neuroscience Institute


acronym: Olaparib in combination with pembrolizumab in HRRm and HRD positive cancer

title: A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Cannon TL, Randall JN BA, Sokol ES, Alexander SM, Wadlow RC, Winer AA, Barnett DM, Rayes DL BS, Nimeiri HS, McGregor KA. Concurrent BRAFV600E and BRCA Mutations in MSS Metastatic Colorectal Cancer: Prevalence and Case Series of mCRC patients with prolonged OS. Cancer Treat Res Commun. 2022;32:100569. doi: 10.1016/j.ctarc.2022.100569. Epub 2022 Apr 30.

location_country:
Spain
Italy
Ukraine
United States
Peru
Romania
Japan
South Africa
Poland
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Sweden
Canada
Guatemala
Germany
Latvia
Korea, Republic of
France
Colombia

location_facility: Monash Health-Monash Medical Centre ( Site 2205)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1714)

location_facility: Banner MD Anderson Cancer Center ( Site 0049)

location_facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1506)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)

location_facility: Aichi Cancer Center Hospital ( Site 2504)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)

location_facility: Tasman Oncology Research Pty Ltd ( Site 2203)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)

location_facility: National Cancer Center Hospital ( Site 2501)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2000)

location_facility: Riga East Clinical University Hospital ( Site 2103)

location_facility: Hematology and Oncology Institute ( Site 0504)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 1809)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

location_facility: Seoul National University Hospital ( Site 2402)

location_facility: Fundacion Cardiovascular de Colombia ( Site 2907)

location_facility: Vaal Triangle Oncology Centre ( Site 1905)

location_facility: San Francisco Oncology Associates ( Site 0085)

location_facility: Inova Schar Cancer Institute ( Site 0008)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 3205)

location_facility: Okayama University Hospital ( Site 2505)

location_facility: Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)

location_facility: The University of Oklahoma Health Sciences Center ( Site 0050)

location_facility: University Hospitals Cleveland Medical Center ( Site 0016)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 3207)

location_facility: Northeast Georgia Medical Center ( Site 0026)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)

location_facility: Seoul National University Bundang Hospital ( Site 2403)

location_facility: P. Stradina Clinical University Hospital ( Site 2102)

location_facility: Northwest Medical Specialties, PLLC ( Site 0007)

location_facility: Centro Oncologico Riojano Integral ( Site 2703)

location_facility: Cancercare Rondebosch Oncology ( Site 1901)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0801)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 3006)

location_facility: Hospital Clinic i Provincial ( Site 1302)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1300)

location_facility: Medical Centre Consilium Medical ( Site 1712)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

location_facility: Hospital Britanico de Buenos Aires ( Site 2705)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1507)

location_facility: University of California San Francisco ( Site 0015)

location_facility: Skanes Universitetssjukhus Lund. ( Site 2001)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 3208)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 1705)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)

location_facility: Podillya Regional Center of Oncology ( Site 1708)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)

location_facility: Institut du Cancer de Montpellier ( Site 0610)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1702)

location_facility: National Cancer Center Hospital East ( Site 2500)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)

location_facility: Kirovograd Regional oncology Dispensary ( Site 1716)

location_facility: Parkland Health & Hospital System ( Site 0091)

location_facility: Centro Medico Zambrano Hellion ( Site 3105)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)

location_facility: Banner MD Anderson Cancer Center ( Site 0092)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0024)

location_facility: Zhytomyr Regional Oncology Center ( Site 1710)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0704)

location_facility: University of Texas, Southwestern Medical Center ( Site 0004)

location_facility: Ad-Vance Medical Research LLC ( Site 0505)

location_facility: Pan American Center for Oncology Trials LLC ( Site 0501)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0039)

location_facility: Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)

location_facility: Winship Cancer Institute of Emory University ( Site 0057)

location_facility: New York Cancer and Blood Specialists-Research Department ( Site 0080)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0206)

location_facility: Linear Clinical Research Ltd ( Site 2206)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 2902)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0802)

location_facility: Universitas Annex National Hospital ( Site 1902)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0047)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)

location_facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)

location_facility: Hokkaido University Hospital ( Site 2502)

location_facility: Baskent University Adana Training Hospital ( Site 1509)

location_facility: Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)

location_facility: Japanese Foundation for Cancer Research ( Site 2503)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0087)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1503)

location_facility: Daugavpils Regional Hospital ( Site 2104)

location_facility: Hospital Nacional Cayetano Heredia ( Site 3203)

summary: The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

acronym: RAISE

summary: The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed;in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: Ra Pharmaceuticals

location_country:
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Norway
Japan
Germany

location_facility: Site 169: International University of Health and Welfare Narita Hospital

location_facility: Site 133: Hospital Universitari Vall d'Hebrón

location_facility: Site 163: Tokyo Medical University Hospital

location_facility: Site 116: Neuromuscular Clinic and Research Center

location_facility: Site 4: University of Southern California

location_facility: Site 126: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Site 140: Haukeland University Hospital / Health Bergen

location_facility: Site 193: Krakowska Akademia Neurologii - Centrum Neurologii Kliniczne

location_facility: Site 32: Kansas University Medical Center Research Institute

location_facility: Site 168: Hospital de la Santa Creu i Sant Pau

location_facility: Site 164: University of Virginia Health System

location_facility: Site 205: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Site 11: Montreal Neurological Institute and Hospital (McGill University)

location_facility: Site 138: Hospital Universitario de Basurto

location_facility: Site 211: Specjalistyczne Gabinety Sp. z o.o.

location_facility: Site 192: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Site 123: Northwell Health Neuroscience Institute

location_facility: Site 31: University of California Irvine

location_facility: Site 188: North Shore Medical Group - Glenview

location_facility: Site 33: Detroit medical Center - University Health Center

location_facility: Site 204: Centre Hospitalier Régional Universitaire de Lille

location_facility: Site 128: Medical University of South Carolina

location_facility: Site 153: Toho University Ohashi Medical Center

location_facility: Site 201: Centrum Medyczne Pratia - Warszawa

location_facility: Site 135: Augusta University Medical Center

location_facility: Site 191: Centre Hosptitalier Universitaire d'Angers

location_facility: Site 134: Neurology and Sleep Disorders Clinic

location_facility: Site 119: Oxford University Hospitals NHS Foundation Trust

location_facility: Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Site 209: Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD

location_facility: Site 213: Niepubliczny Zakład Opieki Zdrowotnej NOVO-MED

location_facility: Site 160: Forbes Norris MDA/ALS Research and Treatment Center

location_facility: Site 194: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int

location_facility: Site 132: Università Cattolica del Sacro Cuore - Campus di Milano

location_facility: Site 44: London Health Sciences Centre University Hospital

location_facility: Site 137: Les Hôpitaux Universitaires de Strasbourg

location_facility: Site 45: Center for Neurological Disorders

location_facility: Site 156: Indiana University Health Neuroscience Center

location_facility: Site 105: Pitié-Salpêtrière University Hospital

location_facility: Site 19: University of Texas Southwestern


title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

acronym: REDIRECT

summary:
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.

Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

design_allocation: Non-Randomized

lead_sponsor: Affimed GmbH

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Korea, Republic of
United States
France
Turkey
Germany

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

location_facility: Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

location_facility: University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

location_facility: GUZ Leningrad Regional Clinical Hospital

location_facility: Duran I Reynals Hospital Catalan Institute Of Oncology

location_facility: University of California Los Angeles (UCLA) Health

location_facility: City of Hope Comprehensive Cancer Center

location_facility: KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

location_facility: Gazi University Faculty of Medicine, Department of Internal Diseases

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

location_facility: University of Michigan Health | Rogel Cancer Center

location_facility: Emory University Clinic/Winship Cancer Institute

location_facility: Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: First State Saint-Petersburg Pavlov Medical University

location_facility: University of Washington Seattle Cancer Care Alliance

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

location_facility: Ochsner Clinic Foundation/Precision Cancer Therapies Program

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Seoul National University Bundang Hospital


title: Benefits of Microcor in Ambulatory Decompensated Heart Failure

acronym: BMAD-TX

summary: To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

lead_sponsor: Zoll Medical Corporation

location_country:
Austria
Germany
United States
France

location_facility: Holy Cross Hospital, Medical Group, Cardiology Associates

location_facility: Accel Research Sites - Guardian Winter Park

location_facility: Winter Haven Hospital - BayCare Health System

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Mercer Bucks Cardiology at Jefferson Health

location_facility: Accel Research Sites- Daytona Heart Group

location_facility: Sinai Center for Thrombosis Reserach and Drug Development

location_facility: Methodist Physicians Clinical Heart Consultants

location_facility: Macklenberg Heart Specialists / Focus Clinical Research Solutions

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique

location_facility: Gateway Cardiovascular Research Center, Inc

location_facility: Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie

location_facility: Accel Research Sites - Lake County Medical Group

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Westchester Research Center at Westchester General Hospital

location_facility: CHU Montpellier - Hopital Arnaud de Villeneuve

location_facility: Chu Montpellier - Hopital Arnaud de Villeneuve

location_facility: BronxCare Health System at BronxCare Hospital Center

location_facility: Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5

intervention_type: Device


intervention_type: Genetic

title: Phase 1/2, Dose-escalation Study to Evaluate the Safety, Tolerability and Efficacy of a Single Intravenous Infusion of SPK-3006 in Adults With Late-onset Pompe Disease

lead_sponsor: Spark Therapeutics

location_country:
Denmark
United Kingdom
Italy
Netherlands
Canada
United States
France
Germany

location_facility: University of Kansas Medical Center Research Institute

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino - Neurology, Osp. Molinette

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Lysosomal and Rare Disorders Research & Treatment Center

location_facility: Malattie Metaboliche Universita Degli Studi Di Napoli Federico II

location_facility: The Royal Free London NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: UO Neurologia Azienda Ospedaliera Universitaria Pisana

location_facility: Universita Degli Studi Di Milano, Laboratorio di Biochimica e Genetica della Malattie Neuromuscolari

location_facility: CHU Paris IdF Ouest - Hôpital Raymond Poincaré

location_facility: Friedrich-Baur-Institut Neurologische Klinik Ludwig-Maximilians-Universität München

location_facility: Universita Degli Studi Di Messina - Dipartimento di Medicina Clinica e Sperimentale

location_facility: Centre Hospitalier Régional Universitaire de Lille

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.


acronym: JUVE-BALM

title: Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis

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

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

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

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Instituto da Crianca do Hospital das Clinicas da FMUSP

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

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Morozovsky Children's City Clinical Hospital

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

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

summary: The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA).


acronym: 1L BTC Phase II/III Gemcitabine Plus Cisplatin With or Without M7824

title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ReferenceType: result

ReferenceCitation: Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1). pii: e000564. doi: 10.1136/jitc-2020-000564.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Poland
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Korea, Republic of
United States
Chile
China
France
Japan
Germany

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Centre Georges François Leclerc - Oncologie Médicale

location_facility: Hospital San Pedro de Alcantara - Servicio de Oncologia

location_facility: Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz

location_facility: Instituto de Investigaciones Metabolicas (IDIM)

location_facility: University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion

location_facility: Centro de Investigación Clínica Bradford Hill

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: Vivantes Klinikum Neukoelln - Haematologie und Onkologie

location_facility: Tianjin Medical University Cancer Institute & Hospital

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

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Fudan University Shanghai Cancer Hospital

location_facility: Ironwood Cancer & Research Centers - Chandler II

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

location_facility: Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

location_facility: Seoul National University Bundang Hospital

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

location_facility: Mayo Clinic in Florida - Department of Neurology

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

summary: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.


title: A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Goss CH, Fajac I, Jain R, Seibold W, Gupta A, Hsu MC, Sutharsan S, Davies JC, Mall MA. Efficacy and safety of inhaled ENaC inhibitor BI 1265162 in patients with cystic fibrosis: BALANCE-CF 1, a randomised, phase II study. Eur Respir J. 2022 Feb 17;59(2). pii: 2100746. doi: 10.1183/13993003.00746-2021. Print 2022 Feb.

ReferenceCitation: Goss CH, Jain R, Seibold W, Picard AC, Hsu MC, Gupta A, Fajac I. An innovative phase II trial to establish proof of efficacy and optimal dose of a new inhaled epithelial sodium channel inhibitor BI 1265162 in adults and adolescents with cystic fibrosis: BALANCE-CF(TM) 1. ERJ Open Res. 2020 Dec 7;6(4). pii: 00395-2020. doi: 10.1183/23120541.00395-2020. eCollection 2020 Oct.

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Spain
United Kingdom
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Virginia Commonwealth University Health Systems

location_facility: The University of North Carolina at Chapel Hill

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Stockholm CF-Center , B59, Huddinge Universitetssjukhus

location_facility: University of Texas Southwestern Medical Center

location_facility: Riley Hospital for Children at Indiana University Health

summary: The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.


title: An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

summary: The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Netherlands
Canada
Thailand
Switzerland
Hungary
Korea, Republic of
United States
France
China
Belgium
Germany
Czechia

location_facility: MD Anderson Cancer Center/University of Texas MDACC

location_facility: Columbia University Medical Center- New York Presbyterian


title: A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice

acronym: CIMREAL

summary: The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.

lead_sponsor: UCB Biopharma SRL

location_country:
Spain
Greece
Italy
United Kingdom
Canada
France
Belgium
Germany
Czechia


title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

summary: The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
Argentina
Canada
United States
Chile
France

location_facility:
Local Institution - 0022
Local Institution - 0012
Local Institution - 0011
Local Institution - 0010
Local Institution - 0021
Hackensack University Medical Center
Johns Hopkins University
Local Institution - 0015
Local Institution - 0033
Local Institution - 0025
Local Institution - 0018
Local Institution - 0026
Local Institution - 0024
Local Institution - 0016
Local Institution - 0023
Local Institution - 0028
Local Institution - 0031
Local Institution - 0019
Local Institution - 0013
Local Institution
Washington University
University Of Colorado
Local Institution - 0014
Local Institution - 0009
Local Institution - 0008
Local Institution - 0006
Local Institution - 0017


title: Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

lead_sponsor: Novo Nordisk A/S

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

location_country:
United Kingdom
Spain
United States
France
Germany

summary: Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


title: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination With IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients With Immune Therapy-Naïve, Advanced Urothelial Carcinoma

summary: The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

lead_sponsor: Infinity Pharmaceuticals, Inc.

location_country:
Poland
Serbia
Spain
Italy
United States
France
Czechia

location_facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)

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

location_facility: Oddzial Chorob Rozrostowych Wojewodzki Szpital

location_facility: Hospital Universitario Central de Asturias

location_facility: University of MD - Greenebaum Comprehensive Cancer Center


intervention_type: Other

title: A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

lead_sponsor: Advanced Accelerator Applications

ReferenceCitation: Jungels C, Deleporte A. State of the art and future directions in the systemic treatment of neuroendocrine neoplasms. Curr Opin Oncol. 2021 Jul 1;33(4):378-385. doi: 10.1097/CCO.0000000000000740. Review.

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:
Spain
Italy
United Kingdom
Netherlands
Canada
Korea, Republic of
United States
France
Germany

location_facility: Seoul National University Hospital - Department of Internal Medicine

location_facility: University of Iowa Hospitals and Clinics - Oncology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Severance Hospital, Yonsei University Health System - Medical Oncology

location_facility: Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot

location_facility: Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology

location_facility: USF - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Fondazione Irccs Istituto Nazionale Tumori

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Universitätsklinikum Essen - Klinik für Nuklearmedizin

location_facility: Complejo Hospitalario Universitario Santiago de Compostela

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Institut du Cancer de Montpellier - Oncology

location_facility: University of Kentucky UK Markey Cancer Center

location_facility: London Health Sciences Centre, University of Western Ontario - Oncology

location_facility: CHU-Hôtel Dieu Service de Médecine Nucléaire

location_facility: Seoul National University Bundang Hospital

summary: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)

acronym: M-STAR

summary: The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy

ReferenceCitation: Schmahmann JD, Pierce S, MacMore J, L'Italien GJ. Development and Validation of a Patient-Reported Outcome Measure of Ataxia. Mov Disord. 2021 Oct;36(10):2367-2377. doi: 10.1002/mds.28670. Epub 2021 Jun 11.

lead_sponsor: Biohaven Pharmaceuticals, Inc.

location_country:
United Kingdom
Italy
Austria
United States
France
Germany

location_facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

location_facility: CRC Core Facility Medizinische Hochschule Hannover (MHH)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona

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

location_facility: Confraternitaet Privatklinik Josefstadt in Wien

location_facility: Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

location_facility: St. Josef - Hospital Bochum, Kardiologische Studienambulanz

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Parkinson-Studienzentrum, Klinik für Neurologie

location_facility: Klinik für Neurologie - UKSH - Campus Kiel

location_facility: Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania

location_facility: NYU School of Medicine, NYU Dysautonomia Center

location_facility: UCLA Medical Center / Neurological Services

location_facility: UC San Diego Department of Neurosciences

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH)

location_facility: Pennsylvania State University Hershey Medical Center

location_facility: Columbia University Medical Center, Neurological Institute


acronym: ELEVATE UC 52

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Arena Pharmaceuticals

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Lebanon
Canada
Hungary
Germany
Bulgaria
Moldova, Republic of
Denmark
Taiwan
Belarus
Latvia
Georgia
Estonia
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Belfast Health and Social Care Trust Royal Victoria Hospital

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: San Diego Gastroenterology Medical Associates

location_facility: National Military Medical Clinical Center Main Military Clinical Hospital

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: Dr. Carol Davila Central University Emergency Military Hospital

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

location_facility: Digestive Health Specialists of the Southeast

location_facility: Spedali Civili di Brescia, U.O. Gastroenterologia

location_facility: Saint George University Hospital Medical Center

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: Medical Center Nov Rehabilitatsionen Tsentar EOOD

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Duke University Medical Center GI Clinical Research Unit

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Private Educational Institution of Higher Education "Medical University REAVIZ"

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: Klaipeda University Hospital, Department of Gastroenterology

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Karkonoskie Centrum Badan Klinicznych Lexmedica

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Austin Health Gastroenterology Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Marshall University Department of Clinical Research

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: P. Stradins Clinical University Hospital

location_facility: LTD Israeli-Georgian Medical Research clinic Helsicore

location_facility: Severance Hospital, Yonsei University Health System

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney

location_facility: SAIH "Kemerovo Regional Clinical Hospital

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

location_facility: Health Care Institution "10th City Clinical Hospital"

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: SZTE AOK I.st dept. of Internal Medicine.

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: 1th Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: Clinical Hospital of the Ministry of Health, Labor and Social Protection

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Kocaeli University Research and Training Hospital

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

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

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga

location_facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

location_facility: Fundación Respirar- Centro Médico Dra. De Salvo

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Communal Institution City Clinical Hospital #6, Department of Gastroenterology

location_facility: LLC "Multidisciplinary Medical Clinic "Anthurium"

location_facility: RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

acronym: SPHINX

summary: Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

ipd_sharing_description:
Actelion is a Janssen pharmaceutical company of Johnson & Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

location_country:
Brazil
Spain
Italy
United Kingdom
Netherlands
Canada
France
United States
Belgium
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

location_facility: RBK Lungenzentrum Stuttgart am Robert-Bosch-Krankenhaus

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: Medical University of South Carolina (MUSC) - College of Medicine (COM)


title: A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Active-controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (AMG334 qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients

summary: The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.

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

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

lead_sponsor: Amgen

location_country:
Poland
Portugal
Spain
Greece
Austria
Ireland
Italy
Argentina
Finland
Netherlands
United Kingdom
United States
France
Israel
Belgium
Germany
Slovakia
Czechia

location_facility: Hull and amp East Yorkshire Hospitals NHS Trust

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: IDIM Instituto de Investigaciones Metabolicas

location_facility: Canisius Wilhelmina Hospital Dept of Neurology C-70

location_facility: Hopital Charles Nicolle Departement de Neurologie

location_facility: Texas Institute for Neurological Disorders

location_facility: Hopital Lariboisiere Centre d Urgence des Cephalees

location_facility: Neurologicka a algeziologicka ambulancia SANERA s r o

location_facility: Euromedica General Clinic of Thessaloniki Neurology Dept

location_facility: Aeginition Hospital of Athens, University of Athens

location_facility: New England Regional Headache Center, Inc

location_facility: Neurologische Gemeinschaftpraxis im Bienenkorbhaus

location_facility: Policl.Universit.Campus Bio-Medico Università Campus Bio-Med U.O.C.Area di Oncologia Medica

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Tel Aviv Sourasky Medical Center Ichilov

location_facility: Centro Hospitalar do Porto Hospital Geral de Santo Antonio Serviço de Neurologia

location_facility: General Hospital of Patra O AGIOS ANDREAS Neurology Clinic

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Clinico Universitario de Santiago

location_facility: New England Institute for Neurology and Headache

location_facility: Jessa Ziekenhuis- Campus Virga Jesse Dienst Gastro-entrologie

location_facility: 401 Army General Hospital of Athens Main Centre

location_facility: Ordensklinikum Linz Barmherzigen Schwestern

location_facility: Neurologische Gemeinschaftspraxis Klemt & Bauersachs

location_facility: University Hospital of North Midlands NHS Trust

location_facility: ASST degli Spedali Civili di Brescia Univ degli Studi

location_facility: A O Perugia Osp S Maria Misericordia Loc S Andrea d Fratte

location_facility: Navy Hospital of Athens "NNA" Main Centre


title: A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by 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:
Denmark
Poland
Spain
United Kingdom
Russian Federation
Netherlands
Argentina
Canada
Hungary
United States
France
Turkey
Belgium
Japan
Germany
Slovakia
Czechia

summary: This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines


title: A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease

acronym: FALCON

summary: This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.

lead_sponsor: Reata Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Nephrology Associates of Northern Virginia, Inc.

location_facility: University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation

location_facility: Japan Community Healthcare Organization Sendai Hospital

location_facility: Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

location_facility: University of Colorado Anschutz Medical Center

location_facility: University of Cincinnati College of Medicine

location_facility: Niigata University Medical & Dental Hospital

location_facility: Tokyo Women's Medical University Hospital

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Brookview Hills Research Associates, LLC

location_facility: Paragon Health PC d/b/a Nephrology Center PC

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Renal Division, ASST Santi Paolo e Carlo

location_facility: Manchester University NHS Foundation Trust

location_facility: University of Maryland School of Medicine

location_facility: Nephrology Dept., General Teaching Hospital

location_facility: Kansas Nephrology Research Institute, LLC

location_facility: KidneyCare and Tranplant Services of New England

location_facility: North Carolina Nephrology, P.A. 2nd Floor

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Division of Kidney Diseases and Hypertension

location_facility: Mountain Kidney & Hypertension Associates

location_facility: Hopital Necker, Universite Paris Descartes

location_facility: Western Nephrology and Mineral Bone Disease, PC


title: A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer

summary: This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.

primary_purpose: Basic Science

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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).

lead_sponsor: Genentech, Inc.

location_country:
Spain
United Kingdom
Australia
United States
France
Belgium

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: University of Colorado Health Lone Tree Medical Center

location_facility: Onkologikoa - Instituto Oncológico de Donostia

location_facility: Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry

location_facility: Fiona Stanley Hospital; Investigational Drugs, Pharmacy Department

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

intervention_type: Procedure


title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 2

summary:
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

lead_sponsor: Zealand Pharma

location_country:
Denmark
Poland
United Kingdom
Italy
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Division of Gastroenterology and Hepatology

location_facility: University of Chicago Children's Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka

location_facility: University Health Network - Toronto General Hospital

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: Azienda Ospedaliero Universitaria Federico II

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: Universitätsklinikum Tübingen - Innere Medizin I


title: A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)

acronym: TWINSS

summary: This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

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

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

location_country:
United Kingdom
Italy
United States
Romania
Japan
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Brazil
Canada
Hungary
Germany
Greece
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

summary: This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Serbia
United Kingdom
Russian Federation
Estonia
Ukraine
United States
France
India
South Africa
Japan
Netherlands
Bulgaria
Slovakia
Czechia


primary_purpose: Prevention

acronym: rVWF Pediatric and Adult Study

title: A Phase 3b, Prospective, Open-Label, Uncontrolled, Multicenter Study on Long-Term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)

lead_sponsor: Baxalta now part of Shire

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

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
United States
France
Turkey
Germany

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital General Universitario de Alicante

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of Florida College of Medicine

location_facility: Medical University of South Carolina (MUSC)

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

summary:
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment.

The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

lead_sponsor: Hoffmann-La Roche

location_country:
Taiwan
Spain
Greece
United Kingdom
Korea, Republic of
United States
France

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: Hospital General Universitario Gregorio Mara

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Churchill Hospital; Pharmacy Clinical Trials Office, Pharmacy Department

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO

location_facility: University of Kentucky Chandler Medical Center

location_facility: Severance Hospital; Yonsei Cancer Center; Yonsei University College of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: University Hospital of Patras Medical Oncology

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital


title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

acronym: ISAKIDS

summary:
Primary Objective:

To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)

Secondary Objectives:

Safety and tolerability assessments
Assessment of infusion reactions (IRs)
Pharmacokinetics (PK) of isatuximab
Minimal residual disease
Overall response rate
Overall survival
Event free survival
Duration of response
Relationship between clinical effects and CD38 receptor density and occupancy

lead_sponsor: Sanofi

location_country:
Denmark
Brazil
Portugal
Greece
Italy
Netherlands
Argentina
Sweden
Hungary
Korea, Republic of
United States
France
Peru
Mexico
Norway
Germany
Czechia

location_facility: Sarah Cannon Research Institute-Site Number:8400001

location_facility: Children's Medical Center of Dallas-Site Number:8400002