title: EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial

summary: Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.

ReferenceType: background

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ReferenceCitation: Khashab MA, Messallam AA, Penas I, Nakai Y, Modayil RJ, De la Serna C, Hara K, El Zein M, Stavropoulos SN, Perez-Miranda M, Kumbhari V, Ngamruengphong S, Dhir VK, Park DH. International multicenter comparative trial of transluminal EUS-guided biliary drainage via hepatogastrostomy vs. choledochoduodenostomy approaches. Endosc Int Open. 2016 Feb;4(2):E175-81. doi: 10.1055/s-0041-109083. Epub 2016 Jan 15.

ReferenceCitation: Khashab MA, Van der Merwe S, Kunda R, El Zein MH, Teoh AY, Marson FP, Fabbri C, Tarantino I, Varadarajulu S, Modayil RJ, Stavropoulos SN, Penas I, Ngamruengphong S, Kumbhari V, Romagnuolo J, Shah R, Kalloo AN, Perez-Miranda M, Artifon EL. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30.

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ReferenceCitation: Almadi MA, Barkun JS, Barkun AN. Stenting in Malignant Biliary Obstruction. Gastrointest Endosc Clin N Am. 2015 Oct;25(4):691-711. doi: 10.1016/j.giec.2015.06.002. Epub 2015 Aug 28.

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ReferenceCitation: Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17. doi: 10.1016/j.gie.2018.03.012. Epub 2018 Mar 21.

ReferenceCitation: Lee TH, Choi JH, Park do H, Song TJ, Kim DU, Paik WH, Hwangbo Y, Lee SS, Seo DW, Lee SK, Kim MH. Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2016 Jul;14(7):1011-1019.e3. doi: 10.1016/j.cgh.2015.12.032. Epub 2015 Dec 31.

ReferenceCitation: Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2. Erratum In: Am J Gastroenterol. 2018 Oct;113(10):1566.

ReferenceCitation: Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.

ReferenceCitation: Kunda R, Perez-Miranda M, Will U, Ullrich S, Brenke D, Dollhopf M, Meier M, Larghi A. EUS-guided choledochoduodenostomy for malignant distal biliary obstruction using a lumen-apposing fully covered metal stent after failed ERCP. Surg Endosc. 2016 Nov;30(11):5002-5008. doi: 10.1007/s00464-016-4845-6. Epub 2016 Mar 11.

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ReferenceCitation: Kamarajah SK, Burns WR, Frankel TL, Cho CS, Nathan H. Validation of the American Joint Commission on Cancer (AJCC) 8th Edition Staging System for Patients with Pancreatic Adenocarcinoma: A Surveillance, Epidemiology and End Results (SEER) Analysis. Ann Surg Oncol. 2017 Jul;24(7):2023-2030. doi: 10.1245/s10434-017-5810-x. Epub 2017 Feb 17.

ReferenceCitation: Chen YI, Callichurn K, Chatterjee A, Desilets E, Fergal D, Forbes N, Gan I, Kenshil S, Khashab MA, Kunda R, Lam E, May G, Mohamed R, Mosko J, Paquin SC, Sahai A, Sandha G, Teshima C, Barkun A, Barkun J, Bessissow A, Candido K, Martel M, Miller C, Waschke K, Zogopoulos G, Wong C; ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC). ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction. Trials. 2019 Dec 9;20(1):696. doi: 10.1186/s13063-019-3918-y.

repository_institution: University of Ottawa - uO Research

repositories_institution:
PubMed Central - Europe PMC
University of Ottawa - uO Research

publisher_dissemination: Springer-Nature

lead_sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

location_country: Canada France

location_facility: Centre Hospitalier Universite de Montreal

intervention_type: Procedure


title:
A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL)

 Essai de phase 3, multicentrique, randomisé, en double aveugle, contrôlé par placebo, visant à comparer l'efficacité et l'innocuité du tafasitamab plus lénalidomide en association avec la chimiothérapie R-CHOP par rapport à la chimiothérapie R-CHOP seule chez des patients à risque intermédiaire et à risque élevé présentant un lymphome diffus à grandes cellules B (LDGCB) récemment diagnostiqué n'ayant jamais été traités

acronym: frontMIND

source: euctr

lead_sponsor: MorphoSys AG

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

lead_sponsor: Alector Inc.


title: A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

lead_sponsor: BeiGene, Ltd.


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive Ovarian Cancer (UP-NEXT)

lead_sponsor: Mersana Therapeutics, Inc.


study_start_date_type: Actual

acronym: ADmIRe

intervention_type: Drug

lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug LY3375880 is safe and effective in adults with moderate-to-severe atopic dermatitis (AD).

location_facility: Kyoto Prefectural University of Medicine

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Piedmont Plastic Surgery and Dermatology

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Instituto de Neumonología y Dermatología

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

location_facility: The Guenther Dermatology Research Centre

status: Terminated

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

enrollment_type: Actual

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Hungary
Argentina
Japan
Austria
Mexico
United States
Spain
Czechia
Canada
Puerto Rico
France

ipd_sharing: Yes

status_simplified: Unknown


title: A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

acronym: REDWOOD

summary: A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

ipd_sharing: No

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Germany
Poland
New Zealand
Australia
Canada
France
Portugal
Hungary
Denmark
United States
Ukraine
Estonia
Italy
United Kingdom
Austria
Spain
Bulgaria
Russian Federation
Israel

location_facility: FSBI National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the MOH of the Russian Federation

location_facility: Charite - Campus Virchow-Klinikum, Klinik fur Neurologie

location_facility: FSBI Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Perron Institute for Neurological and Translational Science

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

location_facility: City Neurological Center Sibneiromed, LLC

location_facility: University of Texas Southwestern Medical Center

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)

location_facility: Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: FSBI of Science Institute of Human Brain named after N .P. Bekhtereva of Russian Academy of Sciences

location_facility: Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council

location_facility: Saint Petersburg State Budgetary Institution of Healthcare City Hospital #40 of Kurortnyi Region

location_facility: Universitatsklinikum Tulln Abteilung fur Neurologie

location_facility: Azienda Ospedaliero-Universitaria Pisana- Ospedale S. Chiara, U.O. di Neurologia - Neurofisiopatologia

location_facility: Colorado Springs Neurological Associates, PC

location_facility: Universita di Bologna-Clinica Neurologica - Dipt di Scienze Neurologiche Ospedale Bellaria

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: University of Calgary Teaching Research and Wellness Building

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona

location_facility: University of Cincinnati Medical Center (UCGNI)

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia

location_facility: Ohio State University - Wexner Medical Center

location_facility: Universita degli studi Gabriele D' Annunzio Chieti

location_facility: Clinical Research Centre, William Harvey Heart Centre

location_facility: Medizinische Universitat Innsbruck, Abteilung fur Neurologie

location_facility: Wake Forest University Baptist Health Sciences

location_facility: Krakowska Akademia Neurologii Sp. Zo.o. Centrum Neurologii Klinicznej

location_facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital #34

location_facility: Parkinson's Disease and Movement Disorders Center

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: The Royal Melbourne Hospital Neurology Department

location_facility: Concord Hospital, Neurosciences Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders

location_facility: Communal Institution Acad. O.I. Yuschenko VRPsH Vinnytsia M.I. Pyrogov NMU Ch of ND with the Course of Neurosurgery

location_facility: Montreal Neurological Institute & Hospital


title: A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

acronym: DAHLIA

summary: This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

status: Completed

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Ireland
Finland
Italy
Slovenia
Portugal
Norway
United Kingdom
Sweden
Netherlands
United States
Spain
Turkey
Czechia
France

location_facility: Oslo University Hospital - Rikshospitalet

location_facility: Azienda Ospedaliera S. Croce e Carle Cuneo

location_facility: Azienda Ospedaliera San Gerardo di Monza

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

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Children's Healthcare of Atlanta at Egleston

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Ege Universitesi Hastanesi - Sağlık Uygulama ve Araştırma Merkezi

status_simplified: Completed


title: E²-RADIatE: EORTC-ESTRO RADiotherapy InfrAstrucTure for Europe

summary: The primary objective is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. This is an open ended prospective non-interventional non-therapeutic multi-cohort study.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

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

location_country:
Germany
Italy
Slovenia
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
Czechia
France

location_facility: Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH

location_facility: Hospital Universitario de Salamanca (430)

location_facility: Centro Nazionale di Adroterapia Oncoloica par il trattamento dei tumori

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

location_facility: Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Policlinico Universitario Campus Bio-Medico- Oncology Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Hospital General Universitario Santa Lucia

location_facility: Radboudumc - Radboud University Medical Center Nijmegen

location_facility: Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Medical University of Graz - Radio-oncology

location_facility: The Christie NHS Foundation trust - The Christie NHS Foundation Trust


title: A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)

lead_sponsor: Seagen Inc.


title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY, PK, AND BIOMARKER EFFECTS OF PTC857 IN ADULT SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (CARDINALS)

acronym: CARDINALS

lead_sponsor: PTC Therapeutics, Inc.


title: A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen

acronym: ONWARD

lead_sponsor: Biogen Idec Research Limited


title: A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

acronym: Pembrolizumab plus axitinib vs. sunitinib monotherapy in advanced/metastatic renal cell carcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease

lead_sponsor: Takeda Development Center Americas, Inc.


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

lead_sponsor: Turning Point Therapeutics, Inc.


title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

acronym: VALIANT

lead_sponsor: Apellis Pharmaceuticals, Inc.


title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer – (KEYNOTE-355)

acronym: A Phase III Study of Chemotherapy ± Pembrolizumab in 1L Triple Negative Breast Cancer


title: A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

lead_sponsor: UCB Biopharma SRL


title: A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease

acronym: FALCON

lead_sponsor: Reata Pharmaceuticals, Inc.


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

lead_sponsor: Caelum Biosciences, Inc.


title: A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA)


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

lead_sponsor: Amicus Therapeutics, Inc.


title: Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)

lead_sponsor: Antisoma Research Ltd.


summary: The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

ReferenceType: derived

ReferenceCitation: Garweg C, Khelae SK, Chan JYS, Chinitz L, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Willems R, Splett V, Stromberg K, Sheldon T, Kristiansen N, Steinwender C. Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias. J Cardiovasc Electrophysiol. 2021 Jul;32(7):1947-1957. doi: 10.1111/jce.15061. Epub 2021 May 20.

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

host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
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PubMed Central
sdu.dk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;sdu.dk

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Garweg C, Khelae SK, Steinwender C, Chan JYS, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Willems R, Sheldon T, Splett V, Stromberg K, Wood N, Chinitz L. Predictors of atrial mechanical sensing and atrioventricular synchrony with a leadless ventricular pacemaker: Results from the MARVEL 2 Study. Heart Rhythm. 2020 Dec;17(12):2037-2045. doi: 10.1016/j.hrthm.2020.07.024. Epub 2020 Jul 24.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: LIRIAS (KU Leuven);sdu.dk

publisher_dissemination: Elsevier

ReferenceCitation: Steinwender C, Khelae SK, Garweg C, Chan JYS, Ritter P, Johansen JB, Sagi V, Epstein LM, Piccini JP, Pascual M, Mont L, Sheldon T, Splett V, Stromberg K, Wood N, Chinitz L. Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study. JACC Clin Electrophysiol. 2020 Jan;6(1):94-106. doi: 10.1016/j.jacep.2019.10.017. Epub 2019 Nov 11.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Hong Kong
Denmark
Austria
Belgium
United States
Spain
Malaysia
France

location_facility: Kepler Universitätsklinikum Med Campus III

location_facility: North Shore University Hospital- Northwell

location_facility: Hospital Universitari Clínic de Barcelona

intervention_type: Device


title: A Phase 1/2/3 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (CTX001) in Subjects With Severe Sickle Cell Disease

summary: This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.

status: Active, not recruiting

ReferenceCitation: Brusson M, Miccio A. Genome editing approaches to beta-hemoglobinopathies. Prog Mol Biol Transl Sci. 2021;182:153-183. doi: 10.1016/bs.pmbts.2021.01.025. Epub 2021 Mar 1.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Frangoul H, Altshuler D, Cappellini MD, Chen YS, Domm J, Eustace BK, Foell J, de la Fuente J, Grupp S, Handgretinger R, Ho TW, Kattamis A, Kernytsky A, Lekstrom-Himes J, Li AM, Locatelli F, Mapara MY, de Montalembert M, Rondelli D, Sharma A, Sheth S, Soni S, Steinberg MH, Wall D, Yen A, Corbacioglu S. CRISPR-Cas9 Gene Editing for Sickle Cell Disease and beta-Thalassemia. N Engl J Med. 2021 Jan 21;384(3):252-260. doi: 10.1056/NEJMoa2031054. Epub 2020 Dec 5.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Modarai SR, Kanda S, Bloh K, Opdenaker LM, Kmiec EB. Precise and error-prone CRISPR-directed gene editing activity in human CD34+ cells varies widely among patient samples. Gene Ther. 2021 Feb;28(1-2):105-113. doi: 10.1038/s41434-020-00192-z. Epub 2020 Sep 1.

repositories_concat: PubMed Central

lead_sponsor: Vertex Pharmaceuticals Incorporated

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
CRISPR Therapeutics

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Canada
France

location_facility: Methodist Children's Hospital/Texas Transplant Institute

location_facility: Regensburg University Hospital, Clinic and Polyclinic for Paediatric and Adolescent Medicine, Paediatric Haemotology, Oncology and Stem Cell Transplantation

location_facility: Hopital Universitaire des Enfants Reine Fabiola (HUDERF)

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Columbia University Medical Center (≤21 years)

location_facility: The Children's Hospital at TriStar Centennial Medical Center/ Sarah Cannon Center for Blood Cancers

location_facility: Royal London and St Bartholomew's Hospital, Pathology and Pharmacy Building

location_facility: Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica Ospedale Pediatrico Bambino Gesu - IRCCS

location_facility: Lucille Packard Children's Hospital of Stanford University

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

location_facility: Columbia University Medical Center (21+ years)

location_facility: University of Illinois at Chicago Hospitals and Health Systems

intervention_type: Biological


title: A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms

lead_sponsor: Cubist Pharmaceuticals, Inc.


title: Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentration-controlled everolimus in liver transplant recipients

lead_sponsor: Novartis Pharma Services AG


title: A Multicenter Study of  the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non infectious Intermediate-, Posterior-, or Pan-uveitis

lead_sponsor: Abbott GmbH & Co. KG


title: A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura

lead_sponsor: Merck & Co., Inc.

status: Prematurely Ended


acronym: Study of LN-144 and LN-145 in the Treatment of Patients with Solid Tumours

lead_sponsor: Iovance Biotherapeutics, Inc.

summary: A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

ReferenceCitation: Hensel J, Metts J, Gupta A, Ladle BH, Pilon-Thomas S, Mullinax J. Adoptive Cellular Therapy for Pediatric Solid Tumors: Beyond Chimeric Antigen Receptor-T Cell Therapy. Cancer J. 2022 Jul-Aug 01;28(4):322-327. doi: 10.1097/PPO.0000000000000603.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Klinikum rechts der Isar der Technischen Universität München

title: A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

design_allocation: Non-Randomized

location_country:
Germany
United Kingdom
Switzerland
United States
Spain
Greece
Canada
France


title: An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

acronym: OPTICS

summary: This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

lead_sponsor: Cortendo AB

location_country:
Italy
Poland
Hungary
Israel
Romania
Netherlands
United States
Spain
Greece
Bulgaria
France

location_facility: Semmelweis Egyetem II. Belgyógyászati Klinika

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: AOU Policlinico G. Martino Sezione di Endocrinologia

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Via Sergio Pansini 5 Uni Naples FedericoII Dept of Molecular&Clinical Endocrinology&Oncology

location_facility: Institutul National de Endocrinologie C.I. Parhon

location_facility: Clinica Endocrinologia malattie del Metabolismo

location_facility: Sveti Georgy University Hospital Clinic of Endocrinology and Metabolic Diseases

location_facility: Hippokration General Hospital Endocrinology and Diabetes Department

location_facility: Bnai Zion Medical Center Endocrinology Institute

location_facility: Washington University School of Medicine

location_facility: University Specialized Hospital for Active Treatment in Endocrinology

location_facility: General Hospital of Athens Evangelismos Department of Endocrinology and Diabete

location_facility: University of New Mexico HSC - HSC Sponsored Projects Office

location_facility: Tel Aviv-Sourasky Medical Center Institute Endocrinology Metabolism & Hypertension


title: A Phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (stage IIIb/IV) non-small cell lung cancer (NSCLC).


title: A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease

lead_sponsor: Schering-Plough Research Institute, a division of Schering Corporation


lead_sponsor: Celgene

summary: This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), or without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c). Approximately 235 subjects will be enrolled into one of three cohorts. Cohort 1 will enroll approximately 97 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: University Of California San Francisco Medical Center

location_facility: University Of Texas Southwestern Medical Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

title: A Phase 2, Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)

location_country:
Germany
Italy
United Kingdom
United States
Spain
France


title: A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents


title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Inactive Non-infectious Intermediate-, Posterior-, or Pan-uveitis


title: A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery.

lead_sponsor: Laboratoires Merck Sharp and Dohme-Chibret


title: NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza.

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.

acronym: IMI/REL (MK-7655A) vs. PIP/TAZ in Treatment of Subjects with HABP/VABP.

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease

summary: The objective of CLI-06657AA1-04 (formerly PB-102-F60) is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who have successfully completed studies PB-102-F03, PB-102-F20 or PB-102-F30.

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country:
Finland
Italy
Slovenia
Hungary
Norway
United Kingdom
Australia
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Eccles Primary Children's Outpatient Services Building

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Haukeland University Hospital Klinisk Forskningspost

location_facility: Renal Disease Research Institute, LLC - Dallas

location_facility: Azienda Ospedaliera Universitaria "Federico II"


title: A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations


lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Czech Republic
Hungary
Denmark
Belgium
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing’s Sarcoma That Has Relapsed After Standard Systemic Therapy.

lead_sponsor: Schering Plough Research Institute


title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control

acronym: Sitagliptin Ped. Pts. Type 2 Diab. Mellitus Inadequate Glycemic Control

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)


title: A 12-week, open label, multicenter, titration study, with a 9-month maintenance treatment extension, to demonstrate efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis


title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase III Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR* and Oxycodone CR in Subjects with Chronic Pain

lead_sponsor: Johnson & Johnson Pharamceutical Resarch & Development, L.L.C


title: A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres

acronym: PROstate

summary: Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.

lead_sponsor: Merit Medical Systems, Inc.

location_country:
United States
Italy
United Kingdom
France

location_facility: Azienda Ospedaliera S. Croce e Carle Cuneo

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: University of Miami- Miller School of Medicine


title: PeriOperative ISchemic Evaluation-3 Trial

summary: This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

ReferenceCitation: Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Cote EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2.

oa_colors: green other

repository_institution: Universiti Malaysia Sarawak - Unimas Institutional Repository

ReferenceCitation: Marcucci M, Painter TW, Conen D, Leslie K, Lomivorotov VV, Sessler D, Chan MTV, Borges FK, Martinez Zapata MJ, Wang CY, Xavier D, Ofori SN, Landoni G, Efremov S, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Wang MK, Fleischmann E, Polanczyk CA, Jayaram R, Astrakov SV, Rao M, VanHelder T, Wu WKK, Cheong CC, Ayad S, Abubakirov M, Kirov M, Bhatt K, de Nadal M, Likhvantsev V, Iglesisas PP, Aguado HJ, McGillion M, Lamy A, Whitlock RP, Roshanov P, Stillo D, Copland I, Vincent J, Balasubramanian K, Bangdiwala SI, Biccard B, Kurz A, Srinathan S, Petit S, Eikelboom J, Richards T, Gross PL, Alfonsi P, Guyatt G, Belley-Cote E, Spence J, McIntyre W, Yusuf S, Devereaux PJ. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery. Trials. 2022 Jan 31;23(1):101. doi: 10.1186/s13063-021-05992-1.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: University of Manitoba - Mspace

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

unpaywall_oa_status: gold

lead_sponsor: Population Health Research Institute

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Pakistan
Chile
Canada
France
Hong Kong
Denmark
United States
India
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Spain
South Africa
Russian Federation

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

location_facility: The Ohio State University Wexner Medical Center

location_facility: Sefako Makgatho Health Sciences University (SMU)

location_facility: Moscow Regional Research & Clinical Institute (MONIKI)

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Sumandeep Vidyapeeth & Dhiraj General Hospital

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Second Hospital of Anhui Medical University

location_facility: Hospital Clínico Universitario in Valladolid

location_facility: V. Negovskiy Reanimatology Research Institute

location_facility: University of North Carolina at Chapel Hill

location_facility: University Health Network (Toronto General Hospital)

location_facility: University of Calgary, O'Brien Institute for Public Health

location_facility: Steve Biko Academic Hospital - University of Pretoria

location_facility: Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Górze

location_facility: E. Meshalkin National Medical Research Center

location_facility: NH Rabindranath Tagore International Inst. of Cardiac Sciences

location_facility: West China Hospital of Sichuan University

location_facility: Specialistyczny Szpital im. E. Szczeklika w Tarnowie

location_facility: Hospital of Saint-Petersburg State University


title: Long term safety and tolerability of satavaptan in patients with cirrhosis of the liver that have been previously randomized and completed treatment in any of the phase III studies: EFC4492; EFC4493 or EFC6682: a double blind parallel group study comparing satavaptan at 5 to 10 mg daily versus placebo

lead_sponsor: sanofi-aventis recherche & développement


title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline versus Ertapenem for the Treatment of Foot Infections in Subjects with Diabetes

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.

acronym: Effect of orally administered BIBF 1120 on FVC decline in IPF

lead_sponsor: Boehringer Ingelheim France SAS


title: The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.

acronym: MALEO

lead_sponsor: Institut de Recherches Internationales Servier


title: A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

lead_sponsor: Wyeth Pharmaceuticals France


title: A multi-center, randomized, open-label, active-controlled study to compare the efficacy, safety and tolerability of taspoglutide (RO5073031) versus insulin glargine in insulin-naive type 2 diabetic patients inadequately controlled with metformin and sulphonylurea combination therapy.

acronym: EMERGE 5

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A 6 MONTH, PROSPECTIVE, OPEN-LABEL MULTIPLE CENTER EXTENSION TRIAL TO EVALUATE THE LONG TERM SAFETY AND SUSTAINED EFFICACY OF FRAGMIN IN THE TREATMENT OF CHRONIC FOOT ULCERS IN DIABETIC PATIENTS WITH PERIPHERAL ARTERIAL OCCLUSIVE DISEASE

lead_sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent


title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis Induced Cardiovascular and Respiratory Failure

lead_sponsor: Takeda Global Research & Development Centre (Europe), Ltd.


title: A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)

acronym: STAR

summary: The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).

ReferenceCitation: Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

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

intervention_type: Genetic


title: Study Title:  A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

acronym: Allegro

lead_sponsor: Teva Pharmaceutical Industries Ltd


title: Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study

lead_sponsor: ACTELION PHARMACEUTICALS LTD


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)

lead_sponsor: Human Genome Sciences, Inc.


title: A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS

lead_sponsor: Pfizer Limited.


title: A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer.


title: A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE)

acronym: Atacicept in generalised SLE Phase II/III

lead_sponsor: Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany


title: A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg versus Dose Titration from 30 mg to 45 mg of ACTOS® Pioglitazone HCl in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy

lead_sponsor: Takeda Global Research & Development Centre (Europe) Limited,


title:
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
 ADOPT: Apixaban Dosing to Optimize Protection from Thrombosis

acronym: ADOPT

lead_sponsor: Bristol Myers Squibb


title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study

acronym: LESS-VT

summary: This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

lead_sponsor: Abbott Medical Devices

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

location_facility: Affinity Cardiovascular Specialists, LLC

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital of the University of Pennsylvania

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


title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE AS THERAPY IN PATIENTS WITH FIBROMYALGIA: A DOUBLE BLIND, RANDOMISED, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIAL

lead_sponsor: BIAL   Portela & Ca, S.A.


title: A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation

lead_sponsor: Cardiome Pharma Corp.


title: A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

acronym: MK-3475 vs. paclitaxel, Docetaxel or vinflunine in metastatic urothelial cancer

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS

acronym: ORAl CLadribine in Early MS (ORACLE MS) Trial

lead_sponsor: Merck Serono International


title: Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study

summary: The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

ReferenceCitation: Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.

lead_sponsor: Allena Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Azienda Socio-Sanitaria Territoriale di Lecco (ASST di Lecco)

location_facility: Universitatsklinikum Freiburg, Klinik for Urologie

location_facility: Universitat Bonn - Zentrum für Kinderheilkunde

location_facility: Albert Einstein College of Medicine Montefiore Medical Center

location_facility: Toronto Digestive Disease Associates, Inc.

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

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: PSHI GmbH; PFÜTZNER Science & Health Institute GmbH

location_facility: University of Alabama, Department of Urology

location_facility: Washington University School of Medicine

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Universitaetsklinikum Bonn; Klinik und Poliklinik für Urologie und Kinderurologie

location_facility: University of North Carolina Chapel Hill

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: University of Alberta, Division of Urology

location_facility: Urological Associates of Southern Arizona

location_facility: Research center of CHU de Québec - Université Laval (CHUL)


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients with Metastatic Colorectal Cancer (MCRC) Treated with Irinotecan  /  5-FU Combination (FOLFIRI) after failure of an oxaliplatin based regimen.

acronym: VELOUR

lead_sponsor: sanofi-aventis recherche & développement


title: A 52-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

acronym: Generation

lead_sponsor: AstraZeneca AB


title: RANDOMIZED, OPEN LABEL, PHASE III TRIAL OF CP-751,871 IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN VERSUS PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH NON-SMALL CELL LUNG CANCER

acronym: CP In Combo

lead_sponsor: Pfizer Inc 235 East 42nd Street New York, NY 10017


title: A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism

acronym: Evaluation of edoxaban vs. warfarin in subjects with symptomatic venous thromboembolism (VTE)

lead_sponsor: Daiichi Sankyo Development Limited


title: Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease

lead_sponsor: Takeda Development Centre Europe, Ltd.


title: Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.

lead_sponsor: F Hoffmann-La Roche Ltd


title: A Phase Ib/II Open Label Study to Assess the Safety and Pharmacokinetics of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Agents Used in Colorectal Cancer Treatment

summary: This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents.

lead_sponsor: NuCana plc

location_country:
United States
United Kingdom
France

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University College London Hospitals NHS Foundation Trust


title: Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients with Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification

lead_sponsor: Sanofi-aventis recherche & développement


title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB

lead_sponsor: Pfizer Inc. - 235 East 42nd Street - New York - 10017


title: Cilengitide in subjects with newly diagnosed glioblastoma multiforme and methylated MGMT gene promoter – a multicenter, open-label, controlled Phase III study, testing cilengitide in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) versus standard treatment alone.

acronym: CENTRIC

lead_sponsor: Merck KGaA


title: A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS).

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title:
An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal

 Etude de phase II, randomisée, en ouvert, avec le BI 754091 seul ou en association avec le BI 836880 chez des patients atteints d’un carcinome épidermoïde métastatique du canal anal résistant à la chimiothérapie, non résécable

lead_sponsor: Boehringer Ingelheim


acronym: ENVISION

lead_sponsor: Alnylam Pharmaceuticals

summary: The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).

ReferenceCitation: Wang B, Ventura P, Takase KI, Thapar M, Cassiman D, Kubisch I, Liu S, Sweetser MT, Balwani M. Disease burden in patients with acute hepatic porphyria: experience from the phase 3 ENVISION study. Orphanet J Rare Dis. 2022 Aug 26;17(1):327. doi: 10.1186/s13023-022-02463-x.

repository_institution: Oxford - Oxford Academix

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of California - eScholarship University of California

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org;iris.unimore.it;jdc.jefferson.edu

ReferenceCitation: Balwani M, Sardh E, Ventura P, Peiro PA, Rees DC, Stolzel U, Bissell DM, Bonkovsky HL, Windyga J, Anderson KE, Parker C, Silver SM, Keel SB, Wang JD, Stein PE, Harper P, Vassiliou D, Wang B, Phillips J, Ivanova A, Langendonk JG, Kauppinen R, Minder E, Horie Y, Penz C, Chen J, Liu S, Ko JJ, Sweetser MT, Garg P, Vaishnaw A, Kim JB, Simon AR, Gouya L; ENVISION Investigators. Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria. N Engl J Med. 2020 Jun 11;382(24):2289-2301. doi: 10.1056/NEJMoa1913147.

repository_institution: King's College London - Research Portal

title: ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Japan
Netherlands
Mexico
Sweden
United States
Korea, Republic of
Spain
Taiwan
Bulgaria
Canada
France


title: InterStim® Amplitude Study

summary: This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

primary_purpose: Basic Science

lead_sponsor: MedtronicNeuro

location_country:
Italy
United Kingdom
Netherlands
Belgium
United States
Canada
France

location_facility: University Urology Associates, Toronto Western Hospital

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Aurora Research Institute - Aurora West Allis Women's Pavilion

location_facility: Academic Urology & Urogynecology of Arizona

location_facility: UZ Leuven - Campus Gasthuisberg - Department Urology

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Adult Pediatric Urology and Urogynecology

location_facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

location_facility: Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System


title: Apixaban Versus Acetylsalicyclic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial  + Administrative Letter to Protocol dated 10-Jul- 2007

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

summary: A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

ReferenceCitation: Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.

ReferenceCitation: Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Germany
Poland
United Kingdom
Hong Kong
Australia
Japan
Netherlands
Austria
Switzerland
United States
Spain
Taiwan
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Hospitals Cleveland Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: John Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic

location_facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis


title: Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC

summary: This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

primary_purpose: Diagnostic

lead_sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

collaborators:
National Cancer Institute (NCI)
GE Healthcare
Bracco Diagnostics, Inc

location_country:
Italy
United Kingdom
Switzerland
United States
Canada
France

location_facility: University of Texas Southwestern Medical Center

lead_sponsor_type: academique


title: A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate

acronym: Atacicept in anti-TNF alfa-naïve subjects with RA

lead_sponsor: Merck Serono International


title: The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.

lead_sponsor: Institut de Recherches Internationales Servier


acronym: MOVE

lead_sponsor: Clementia Pharmaceuticals Inc.

summary: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.

ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-gamma agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum In: Nat Med. 2012 Oct;18(10):1592.

location_facility: University of Pennsylvania, Internal Medicine

location_facility: Hospital for Sick Children, 555 University Avenue

location_facility: Royal National Orthopaedic Hospital, Brockely Hill

location_facility: Hospital Italiano de Buenos Aires, Tte General Juan Domingo Peron 4190

location_facility: University of California San Francisco, Division of Endocrinology and Metabolism

location_facility: Hospital Universitari i Politècnic La Fe, Unidad de Reumatología Pediatrica

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

location_country:
Italy
United Kingdom
Argentina
Australia
Brazil
Japan
Sweden
United States
Spain
Canada
France


title: A Double-blind, Placebo-controlled, Randomized Trial to Determine the Safety and Efficacy of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Painful Diabetic Neuropathy (EMPADINE)

acronym: EMPADINE

summary: The purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).

ReferenceCitation: Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Poland
Bulgaria
Portugal
Slovakia
Hungary
Norway
Denmark
Australia
United Kingdom
Austria
Belgium
Spain
Canada
France


title: A TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment

acronym: TARGET

summary: This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.

time_perspective: Retrospective

ReferenceCitation: Lam M, Garin E, Maccauro M, Kappadath SC, Sze DY, Turkmen C, Cantasdemir M, Haste P, Herrmann K, Alsuhaibani HS, Dreher M, Fowers KD, Salem R. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3340-3352. doi: 10.1007/s00259-022-05774-0. Epub 2022 Apr 8.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Biocompatibles UK Ltd

location_country:
Germany
Italy
Netherlands
Switzerland
United States
Saudi Arabia
Turkey
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Istanbul university Istanbul medical school

location_facility: Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer Center

location_facility: Foundation IRCCS Istituto Nazionale Tumori

location_facility: University of Florida College of Medicine

location_facility: Washington University in St. Louis, School of Medicine


acronym: REFLECT

lead_sponsor: GenSight Biologics

summary: The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional & structural outcomes in subjects with LHON due to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one year.

location_facility: University of Colorado Health Eye Center

location_facility: Wills Eye Institute - Ocular Oncology Service

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna UOC Clinica Neurologica

title: Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year

location_country:
Italy
United Kingdom
Belgium
United States
Spain
Taiwan
France


title: A 6 MONTH, PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FRAGMIN IN THE TREATMENT OF CHRONIC NEUROISCHAEMIC FOOT ULCERS IN DIABETIC PATIENTS

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017


title: Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized Study

lead_sponsor: Fournier Laboratories Ireland


lead_sponsor: Cortendo AB

summary: This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

location_facility: Institutul National de Endocrinologie C.I. Parhon, Sectia Clinica de Endocrinologie II, Patologia tiroidei de corelatie

location_facility: Leiden University, Leiden University Medical Center, Department of Endocrinology

location_facility: APHM Hôpital de la Conception, Service d'Endocrinologie, Diabète et Maladies Métaboliques

location_facility: Memorial Sloan Kettering Cancer Center, Endocrinology

location_facility: UCLA School of Medicine, Medicine/Endocrinology Department

location_facility: University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika

location_facility: University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND

location_facility: Johns Hopkins University, Endocrinology Department

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Sectia Clinica Endocrinologie

location_facility: AOU Federico II, Sezione di Endocrinologia (Edificio 1, Secondo Piano)

location_facility: AOU Policlinico G. Martino Sezione di Endocrinologia

location_facility: The Center for Diabetes and Endocrine Care

location_facility: Instytut Centrum Zdrowia Matki Polki, Oddział Endokrynologii i Chorób Metabolicznych

location_facility: Washington University School of Medicine, Endocrinology

location_facility: Allegheny Neuroendocrinology Center, West Penn Allegheny Health System

location_facility: Hippokration General Hospital, "Endocrinology and Diabetes Department

location_facility: Wojskowy Instytut Medyczny, Klinika Gastroenterologii, Endokrynologii I Chorob Wewnetrznych

location_facility: General Hospital of Athens 'Laiko', "National and Kapodistrian University of Athens Medical School Pathophysiology - Endocrinology"

location_facility: Policlinico Agostino Gemelli, Università Cattolica del Sacro Cuore, Endocrinology

location_facility: Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases

location_facility: Erasmus Medical Center, Department of Internal Medicine

location_facility: Rigshospitalet, Copenhagen University Hospital, Endocrinology Department

location_facility: Clinica di Endocrinologia e malattie del Metabolismo, Dipartimento Specialità Mediche

location_facility: Bnai Zion Medical Center, Institute of Endocrinology

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu", Departamentul de Endocrinologie

location_facility: Policlinico Universitario Sant'Andrea, Scienze Mediche

location_facility: Tel-Aviv Sourasky Medical Center Institute of Endocrinology, Metabolism and Hypertension

location_facility: Northwestern University, Medicine - Endocrinology

location_facility: AOU Citta della Salure e della Scienza SC Endocrinologia, Diabetologia e Metabolismo

location_facility: General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre

location_facility: Columbia University, College of P&S Medicine/Neuro-endocrine Unit

location_facility: Spitalul Clinic Judetean Mures, Compartimentul de Endocrinologie

location_facility: Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center

location_facility: Rabin Medical Center- Beilinson Hospital, "Institute of Endocrinology & Metabolism, Beilinson Campus"

location_facility: Maria Sklodowska-Curie Memorial Institute - Cancer Center Gliwice Branch, Nuclear Medicine and Endocrine Oncology Department

location_facility: Hospital Universidad De La Ribera, Endocrinologia

location_facility: Oregon Health & Science University, Neurological Surgery

location_facility: Evangelismos Athens General Hospital, Department of Endocrinology

location_facility: Semmelweis Egyetem II. Belgyógyászati Klinika A.épület I.emelet ODM-labor

location_facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD Clinic of Endocrinology and Metabolic Diseases

location_facility: Hospital Universitario Ramón y Cajal, Endocrinology and Nutrition

location_facility: Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital

location_facility: University General Hospital of Ioannina, Department of Endocrinology

location_facility: University of Genova, Department of Internal Medicine & Medical Specialties (DiMI)

title: A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome

location_country:
Italy
Poland
Hungary
Israel
Denmark
Romania
Netherlands
United States
Spain
Greece
Bulgaria
France


title: A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION

lead_sponsor: Regado Biosciences, Inc.


title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)


title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)

acronym: OPuS One

summary: This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

ReferenceType: result

ReferenceCitation: Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

location_country:
Germany
United States
Luxembourg
Canada
France

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Banner - University Medical Center Phoenix

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Texas (UT) Southwestern Medical Center


summary: The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: H Lee Moffitt Cancer Center and Research Institute Inc

title: A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

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

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

location_country:
Germany
Italy
Argentina
Singapore
Australia
Japan
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Taiwan
Czechia
France


title: An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

acronym: CALM

lead_sponsor: Abbott GmbH & Co. KG


title: A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <17 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

lead_sponsor: UCB BIOSCIENCES, Inc.


title: Phase I/II, Open-Label, Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Childhood Cerebral Adrenoleukodystrophy (CCALD)

summary: This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: NeuroVia, Inc.

location_country:
Colombia
United Kingdom
Argentina
Australia
Chile
Ukraine
Russian Federation
France

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Great Ormond Street Hospital for Children

location_facility: Hospital General de ninos Pedro de Elizalde

location_facility: Moscow Morozov's Children Clinical Hospital

location_facility: National Children's Specialized Hospital 'OKHMATDET'


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

lead_sponsor: Bayer Schering Pharma AG


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated  Vasculitis on Background Cyclophosphamide or Rituximab Treatment

lead_sponsor: ChemoCentryx, Inc.


title: A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.

acronym: Safinamide in IPD with motor fluctuations, as add-on to levodopa

lead_sponsor: Merck Serono S.A. - Geneva


title: A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects with Advanced Recurrent Ovarian Cancer

acronym: Phase II Study of Pembrolizumab in Subjects with Advanced Recurrent Ovarian Cancer

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY  (THE CONTINUUM TRIAL)

acronym: The Continuum trial

lead_sponsor: Celgene Corporation


title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine

 Étude de phase 3 randomisée, en double aveugle, contrôlée contre placebo, évaluant la sécurité  et l’efficacité de CCX168 (Avacopan) chez des sujets présentant une vascularite associée à des anticorps anti-cytoplasme des polynucléaires neutrophiles (ANCA) traités conjointement avec Rituximab ou Cyclophosphamide/Azathioprine


title: A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

lead_sponsor: MediWound Ltd.


title: Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

summary: Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

lead_sponsor: DePuy Orthopaedics

location_country:
Germany
Ireland
Italy
New Zealand
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Canada
France

location_facility: Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology

location_facility: Asklepios Orthopädische Klinik Lindenlohe

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: The Ohio State University Wexner Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: University of Mississippi Medical Center

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche

location_facility: London Health Sciences Centre University Hospital


title: Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Chemotherapy

acronym: Phase  II  Trial  of  MK-3475  in  Subjects  with  mCRPC  with  Prior Chemotherapy


title: European Low and Intermediate Risk Neuroblastoma

acronym: LINES

lead_sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE DE VALENCIA


title: A Phase III Randomized Open-label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181)

acronym: Study of Pembrolizumab vs Docetaxel, Paclitaxel or Irinotecan in Subjects with Esophagus Carcinoma


title:
A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients ≥18 years of age with severe uncontrolled asthma.

 Étude de 12 semaines, multicentrique, randomisée, en double aveugle, groupes parallèles, contrôlée versus placebo, visant à évaluer l’efficacité et la sécurité d’emploi du CSJ117, lorsqu’il est ajouté au traitement de l’asthme existant chez les patients âgés de ≥ 18 ans souffrant d’asthme sévère non contrôlé

lead_sponsor: Novartis Pharma AG


title:
A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

 Etude de phase III, multicentrique, randomisée, en ouvert, évaluant ABL001 par voie orale versus bosutinib chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC-PC) précédemment traités par au moins 2 inhibiteurs de tyrosine kinase


title:
A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

 Étude de phase IIb en ouvert évaluant l’efficacité et la sécurité d’emploi de l’ABX464 en tant que traitement d’entretien chez des patients atteints de rectocolite hémorragique modérée à sévère.

lead_sponsor: ABIVAX


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

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

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
United Kingdom
United States
Spain
Chile
France

location_facility: Pharmaceutical Research Associates, Inc.

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

location_facility: Memory Enhancement Center of America, Inc.

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

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

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

location_facility: Greater Manchester Mental Health NHS Foundation Trust

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


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

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

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

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

lead_sponsor: Gilead Sciences

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

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Christchurch Clinical Studies Trust, Ltd

location_facility: Emory Hospital Midtown Infectious Disease Clinic

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

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

location_facility: University of Colorado Denver (Leprino Building)

location_facility: New Orleans Center for Clinical Research

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: University of Washington/Harborview Medical Center


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

acronym: TAME

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

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

lead_sponsor: Australian and New Zealand Intensive Care Research Centre

collaborators: National Health and Medical Research Council, Australia

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

location_facility: Cliniques Universitaires de Bruxelles Hospital Erasme

intervention_type: Other


title:
Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER

 Étude multicentrique et randomisée de phase IIB, contrôlée par placebo et en double aveugle, visant à évaluer l’efficacité et la sécurité du dispositif HepaStem chez les patients atteints d’une insuffisance hépatique aiguë sur maladie chronique du foie (ACLF) - DHELIVER

acronym: HEP102 - DHELIVER

lead_sponsor: Promethera Biosciences


title: Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease

acronym: FLOW

lead_sponsor: Novo Nordisk A/S