title: A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER

summary: This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

lead_sponsor: Celgene

location_country:
Finland
Greece
Romania
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Netherlands
Singapore
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
New Zealand
Spain

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Chinese PLA General Hospital / 307 Hospital

location_facility: Istituto Nazionale Tumori Regina Elena di Roma

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: National Hospital Organization - Nagoya Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Cancer Specialists of North Florida - Jacksonville

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

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

location_facility: Fujian Medical University - Fujian Provincial Cancer Hospital

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

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

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

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital

location_facility: Zhengzhou University (ZZU) - Henan Cancer Hospital

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

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

location_facility: Oncology Institute Professor Doctor Alexandru Trestioreanu

location_facility: Hospital Universitario Central de Asturias

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital

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

location_facility: Insular-Maternal and Child University Hospital Complex

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: The First Hospital of Xinjiang Medical University

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Zhejiang Medical University - Zhejiang Cancer Hospital

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Seoul National University Bundang Hospital

location_facility: Ryazan State Medical University n.a. I.P. Pavlov

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Central South University - Xiangya School of Medicine - Hunan Cancer Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Florence Nightingale KH der Kaiserwerther Diakonie

location_facility: Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov

location_facility: Clinical Hospital of the Russian Academy of Sciences

location_facility: Hospital General Universitario de Alicante

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Hospital Universitario Fundacion Jimenez Diaz

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

location_facility: Beijing Cancer Hospital - Beijing Institute for Cancer Research

location_facility: Bengbu Medical College - First Affiliated Hospital

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Norton Healthcare - Norton Cancer Institute

location_facility: Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV

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

location_facility: Sichuan University - West China Hospital

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: University General Hospital of Heraklion

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Medical Study Company NORD-WEST GmbH Oncology Aurich

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


title: A Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Efficacy of Controlled-release Ropinirole (CR) (1-24 mg) Administered Once Daily for 12 Weeks in Subjects With Fibromyalgia

summary: A study to investigate ropinirole for treatment of the symptoms of fibromyalgia and in particular the widespread pain associated with this condition. A total 160 subjects (80 per treatment arm) are being recruited from approximately 25 centres in 9 European countries. Male and female subjects greater than 18 years of age with a diagnosis of primary fibromyalgia, as defined by the American College of Rheumatology (ACR) criteria, are eligible for study entry. Subjects will receive either ropinirole (1-24mg) or placebo, depending upon a statistically defined allocation to treatment. The primary endpoint is improvement in pain score by 12 weeks of treatment. An 11 point numerical rating scale for the assessment of the subject's pain is being collected on a daily diary. In addition, the overall improvement in quality of life for the subject will be assessed by means of a number of subject-completed questionnaires during the treatment period. Safety of the treatment regimen will be assessed throughout the study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Sweden
Netherlands
Finland
France
Belgium
Denmark
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

summary: CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

design_allocation: Non-Randomized

enrollment_type: Actual

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Germany
France
Argentina
Australia
Spain
Canada
United Kingdom

location_facility:
Research Site
Pfizer Investigational Site


title: A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab IV in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31.

name: Vall d'Hebron University Hospital and Institute of Oncology (VHIO) UVic‐UCC, IOB‐Quiron  Barcelona Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

sequence: first

name: Centro de Investigación Clínica Bradford Hill  Santiago Chile

family: Burotto

full_name: Mauricio Burotto

given: Mauricio

sequence: additional

name: Riga Eastern Clinical University Hospital  Riga Latvia

family: Zvirbule

full_name: Zanete Zvirbule

given: Zanete

name: F. Hoffmann‐La Roche, Ltd.  Basel Switzerland

family: Herraez‐Baranda

full_name: Luis A. Herraez‐Baranda

given: Luis A.

family: Chanu

full_name: Pascal Chanu

given: Pascal

name: Genentech, Inc.  South San Francisco California USA

family: Kshirsagar

full_name: Smita Kshirsagar

given: Smita

family: Maiya

full_name: Vidya Maiya

given: Vidya

family: Chan

full_name: Phyllis Chan

given: Phyllis

family: Pozzi

full_name: Emanuela Pozzi

given: Emanuela

name: Certara Strategic Consulting  Paris France

family: Marchand

full_name: Mathilde Marchand

given: Mathilde

family: Monchalin

full_name: Marion Monchalin

given: Marion

family: Tanaka

full_name: Kunihiko Tanaka

given: Kunihiko

family: Tosti

full_name: Nadia Tosti

given: Nadia

family: Wang

full_name: Bei Wang

given: Bei

family: Restuccia

full_name: Eleonora Restuccia

given: Eleonora

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Pharmacology in Drug Development

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Results of a Dose‐Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non–Small Cell Lung Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Guatemala
Greece
Russian Federation
Ukraine
Costa Rica
France
Poland
Thailand
Argentina
Korea, Republic of
South Africa
Chile
Bulgaria
Hungary
China
United Kingdom
Italy
Brazil
Mexico
New Zealand
Spain
Turkey
Latvia

location_facility: Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

location_facility: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Szpital Morski Im. Pck; Oncology & Radiotherapy Dept

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Samsung Medical Centre; Medical Oncology

location_facility: James Lind Centro de Investigación Del Cáncer

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Medipol University MF; Oncology Department

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology

location_facility: Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: UMHAT Dr Georgi Stranski; Medical Oncology Department

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: West China Hospital - Sichuan University

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Harbin Medical University Cancer Hospital

location_facility: National Cancer Institute; Clinical Research center

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

status_simplified: Ongoing


type: EudraCT Number

title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy

summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.

ReferenceCitation: Padilla B, Shields AL, Taylor F, Li X, Mcdonald J, Green T, Boral AL, Lin HM, Akin C, Siebenhaar F, Mar B. Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study. Orphanet J Rare Dis. 2021 Oct 18;16(1):434. doi: 10.1186/s13023-021-02037-3.

family: Padilla

full_name: Brad Padilla

given: Brad

family: Shields

full_name: Alan L. Shields

given: Alan L.

family: Taylor

full_name: Fiona Taylor

given: Fiona

family: Li

full_name: Xiaoran Li

given: Xiaoran

family: Mcdonald

full_name: Jeffrey Mcdonald

given: Jeffrey

family: Green

full_name: Tanya Green

given: Tanya

family: Boral

full_name: Anthony L. Boral

given: Anthony L.

family: Lin

full_name: Hui-Min Lin

given: Hui-Min

family: Akin

full_name: Cem Akin

given: Cem

family: Siebenhaar

full_name: Frank Siebenhaar

given: Frank

family: Mar

full_name: Brenton Mar

given: Brenton

currency_apc_doaj: GBP

journal_name: Orphanet Journal of Rare Diseases

oa_colors: green gold

evidence: oa journal (via doaj)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Blueprint Medicines Corporation

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

location_facility: NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Universitätsmedizin Mannheim, III. Medizinische Klinik

location_facility: Winship Cancer Institute, Emory University

location_facility: A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: University Medical Center Groningen (UMCG)

location_facility: Oslo Universitetssykehus, Rikshospitalet, Department of Hematology

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Washington University School of Medicine

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Poloclinico, UOC Ematologia

location_facility: University Clinic Hamburg Eppendorf, University Cancer Center Hamburg (UCCH)

location_facility: Virginia Commonwealth University Medical Center

location_facility: Odense Universitetshospital, ORCA/Allergicentret, Hudafdeling I og Allergicenter

location_facility: Michigan Medicine, University of Michigan

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHU Toulouse Larrey, CEREMAST, Service de Dermatologie et Allergologie cutanée

location_facility: Karolinska University Hospital, Hematologimottagningen R51

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Hôpital de la Timone, Service de dermatologie

location_facility: lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo

location_facility: Hôpital Pitié-Salpêtrière, Service de Dermatologie

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Universitätsklinik Mainz, Universitäts-Hautklinik, Clinical Research Center

location_facility: A.O.U di Bologna - IRCCS, Istituto di Ematologia Lorenzo e Ariosto Seragnoli, Ematologia


title: Aripiprazole (BMS-337039) for Outpatients With Schizophrenia Completing Aripiprazole Clinical Trials: A Non-Comparative Rollover Protocol

summary: The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
South Africa
United Kingdom
Netherlands
Croatia
France
Poland
Romania
Hungary
Russian Federation
Canada
Czech Republic


title: A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

summary:
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of Erosive Esophagitis and Improvement of Symptoms of Gastroesophageal Reflux Disease After Esomeprazole Treatment in Children 12 to 36 Months Old. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.

family: Tolia

full_name: Vasundkara Tolia

given: Vasundkara

family: Gilger

full_name: Mark A. Gilger

given: Mark A.

family: Barker

full_name: Peter N. Barker

given: Peter N.

family: Illueca

full_name: Marta Illueca

given: Marta

journal_name: Journal of Pediatric Gastroenterology & Nutrition

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.

full_name: Vasundhara Tolia

given: Vasundhara

family: Youssef

full_name: Nader N. Youssef

given: Nader N.

family: Traxler

full_name: Barry Traxler

given: Barry

ReferenceCitation: Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8. doi: 10.1097/MPG.0b013e3181ddcf11.

ReferenceCitation: Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41. doi: 10.1186/1471-2431-10-41.

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

ReferenceCitation: Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33. doi: 10.1097/MPG.0b013e318176b2cb.

title: Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease


type: Other Identifier

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma

summary: The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

ReferenceCitation: Wenzel SE, Barnes PJ, Bleecker ER, Bousquet J, Busse W, Dahlén SE, Holgate ST, Meyers DA, Rabe KF, Antczak A, Baker J, Horvath I, Mark Z, Bernstein D, Kerwin E, Schlenker-Herceg R, Lo KH, Watt R, Barnathan ES, Chanez P; T03 Asthma Investigators. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009 Apr 1;179(7):549-58. doi: 10.1164/rccm.200809-1512OC. Epub 2009 Jan 8.

family: Wenzel

full_name: Sally E. Wenzel

given: Sally E.

family: Barnes

full_name: Peter J. Barnes

given: Peter J.

family: Bleecker

full_name: Eugene R. Bleecker

given: Eugene R.

family: Bousquet

full_name: Jean Bousquet

given: Jean

family: Busse

full_name: William Busse

given: William

family: Dahlén

full_name: Sven-Erik Dahlén

given: Sven-Erik

family: Holgate

full_name: Stephen T. Holgate

given: Stephen T.

family: Meyers

full_name: Deborah A. Meyers

given: Deborah A.

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

family: Antczak

full_name: Adam Antczak

given: Adam

family: Baker

full_name: James Baker

given: James

family: Horvath

full_name: Ildiko Horvath

given: Ildiko

family: Mark

full_name: Zsuzsanna Mark

given: Zsuzsanna

family: Bernstein

full_name: David Bernstein

given: David

family: Kerwin

full_name: Edward Kerwin

given: Edward

family: Schlenker-Herceg

full_name: Rozsa Schlenker-Herceg

given: Rozsa

family: Lo

full_name: Kim Hung Lo

given: Kim Hung

family: Watt

full_name: Rosemary Watt

given: Rosemary

family: Barnathan

full_name: Elliot S. Barnathan

given: Elliot S.

family: Chanez

full_name: Pascal Chanez

given: Pascal

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: A Randomized, Double-blind, Placebo-controlled Study of Tumor Necrosis Factor-α Blockade in Severe Persistent Asthma

lead_sponsor: Centocor, Inc.

location_country:
Sweden
United Kingdom
Netherlands
Germany
France
Bulgaria
Poland
Hungary
Belgium
United States
Czech Republic


title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

acronym: RADIANCE-II

summary: The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

lead_sponsor: ReCor Medical, Inc.

location_country:
United States
Switzerland
Netherlands
France
Ireland
Belgium
Germany
United Kingdom

location_facility: The University of Tennessee Health Science Center

location_facility: Centre Hospitalier Universitaire Saint-Pierre

location_facility: Cardiology Associates of North Mississippi

location_facility: Central Arkansas Veterans Healthcare System

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University of Pennsylvania Health System

location_facility: Hôpital Européen Georges-Pompidou (HEGP)

location_facility: University Hospitals Dorset NHS Foundation Trust

location_facility: The Cardiothoracic Centre Basildon University Hospital

location_facility: The University of North Carolina at Chapel Hill

intervention_type: Device


title: Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women

summary: The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.

ReferenceCitation: Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130.

family: Christiansen

full_name: Claus Christiansen

given: Claus

family: Chesnut

full_name: Charles H Chesnut

given: Charles H

suffix: III

family: Adachi

full_name: Jonathan D Adachi

given: Jonathan D

family: Brown

full_name: Jacques P Brown

given: Jacques P

family: Fernandes

full_name: César E Fernandes

given: César E

family: Kung

full_name: Annie WC Kung

given: Annie WC

family: Palacios

full_name: Santiago Palacios

given: Santiago

family: Levine

full_name: Amy B Levine

given: Amy B

family: Chines

full_name: Arkadi A Chines

given: Arkadi A

family: Constantine

full_name: Ginger D Constantine

given: Ginger D

journal_name: BMC Musculoskeletal Disorders

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

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

publisher_group: Springer

title: Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis

lead_sponsor: Pfizer

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
South Africa
Chile
Hong Kong
Netherlands
Bulgaria
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
New Zealand
Spain
Estonia

intervention_type: Other


lead_sponsor: CymaBay Therapeutics, Inc.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Israel
New Zealand
Spain

location_facility: Center for Liver Disease and Transplantation

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Minnesota Medical Center, Fairview

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Schiff Center for Liver Diseases University of Miami

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The Newcastle Upon Tyne Hospital NHS Foundation Trust

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Pius Brinzeu Emergency Clinical County Hospital

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Gastroenterologisch Hepatologisches Zentrum Kiel

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of California Davis Medical Center

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: Yale School of Medicine Digestive Diseases, Internal Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: Seoul National University Bundang Hospital

location_facility: ifi-Institute for Interdisciplinary Medicine

location_facility: Southern Therapy and Advance Research (STAR) LLC

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Pontificia Universidad Catolica de Chile

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: American Research Corporation at Texas Liver Institute

location_facility: Univeristy of Colorado Denver and Hospital

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: University of Texas Southwestern Medical Center

source: euctr

title: A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

summary: A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)


title: A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

summary: To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

family: Ryan

full_name: Caitriona Ryan

given: Caitriona

family: Sobell

full_name: Jeffrey M. Sobell

given: Jeffrey M.

family: Leonardi

full_name: Craig L. Leonardi

given: Craig L.

family: Lynde

full_name: Charles W. Lynde

given: Charles W.

family: Karunaratne

full_name: Mahinda Karunaratne

given: Mahinda

family: Valdecantos

full_name: Wendell C. Valdecantos

given: Wendell C.

family: Hendrickson

full_name: Barbara A. Hendrickson

given: Barbara A.

journal_name: American Journal of Clinical Dermatology

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

ReferenceCitation: Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

family: Schreiber

full_name: S. Schreiber

given: S.

family: Reinisch

full_name: W. Reinisch

given: W.

family: Colombel

full_name: J.F. Colombel

family: Sandborn

full_name: W.J. Sandborn

family: Hommes

full_name: D.W. Hommes

family: Robinson

full_name: A.M. Robinson

family: Huang

full_name: B. Huang

given: B.

family: Lomax

full_name: K.G. Lomax

family: Pollack

full_name: P.F. Pollack

title: Subgroup analysis of the placebo-controlled CHARM trial: Increased remission rates through 3years for adalimumab-treated patients with early Crohn's disease

ReferenceCitation: Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Italy
United States
South Africa
Sweden
Netherlands
Germany
France
Poland
Hungary
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility:
Site Ref # / Investigator 1884
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Site Ref # / Investigator 1880
Site Ref # / Investigator 1945
Site Ref # / Investigator 1872
Site Ref # / Investigator 1883
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Site Ref # / Investigator 1856
Site Ref # / Investigator 1888
Site Ref # / Investigator 2457
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Site Ref # / Investigator 1878
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Site Ref # / Investigator 6178
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Site Ref # / Investigator 1773
Site Ref # / Investigator 1904
Site Ref # / Investigator 1870
Site Ref # / Investigator 1862
Site Ref # / Investigator 2534
Site Ref # / Investigator 1911
Site Ref # / Investigator 1914
Site Ref # / Investigator 1787
Site Ref # / Investigator 1861
Site Ref # / Investigator 1937
Site Ref # / Investigator 1848
Site Ref # / Investigator 1881
Site Ref # / Investigator 1763
Site Ref # / Investigator 1826
Site Ref # / Investigator 1786
Site Ref # / Investigator 1829
Site Ref # / Investigator 341
Site Ref # / Investigator 1901
Site Ref # / Investigator 1822
Site Ref # / Investigator 1951
Site Ref # / Investigator 2524
Site Ref # / Investigator 1882
Site Ref # / Investigator 1891
Site Ref # / Investigator 1938
Site Ref # / Investigator 1887
Site Ref # / Investigator 1874
Site Ref # / Investigator 1850
Site Ref # / Investigator 1941
Site Ref # / Investigator 1849
Site Ref # / Investigator 1824
Site Ref # / Investigator 1846
Site Ref # / Investigator 1949
Site Ref # / Investigator 1779
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Site Ref # / Investigator 1944
Site Ref # / Investigator 1913
Site Ref # / Investigator 1858
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Site Ref # / Investigator 1894
Site Ref # / Investigator 1771
Site Ref # / Investigator 2459
Site Ref # / Investigator 1902
Site Ref # / Investigator 1852
Site Ref # / Investigator 2458
Site Ref # / Investigator 1948
Site Ref # / Investigator 1873
Site Ref # / Investigator 1772
Site Ref # / Investigator 1778
Site Ref # / Investigator 1823
Site Ref # / Investigator 1825
Site Ref # / Investigator 1866
Site Ref # / Investigator 2535
Site Ref # / Investigator 1833
Site Ref # / Investigator 1943
Site Ref # / Investigator 1841
Site Ref # / Investigator 1782
Site Ref # / Investigator 1922
Site Ref # / Investigator 1924
Site Ref # / Investigator 1863
Site Ref # / Investigator 342
Site Ref # / Investigator 5189
Site Ref # / Investigator 1946
Site Ref # / Investigator 1919
Site Ref # / Investigator 1876
Site Ref # / Investigator 1844
Site Ref # / Investigator 426
Site Ref # / Investigator 1853
Site Ref # / Investigator 1935
Site Ref # / Investigator 1909
Site Ref # / Investigator 1963
Site Ref # / Investigator 1868
Site Ref # / Investigator 1886
Site Ref # / Investigator 1942
Site Ref # / Investigator 1903
Site Ref # / Investigator 6180
Site Ref # / Investigator 1896
Site Ref # / Investigator 1860
Site Ref # / Investigator 1892
Site Ref # / Investigator 1897
Site Ref # / Investigator 1895
Site Ref # / Investigator 1855
Site Ref # / Investigator 2602
Site Ref # / Investigator 1900
Site Ref # / Investigator 1875
Site Ref # / Investigator 1890
Site Ref # / Investigator 1906
Site Ref # / Investigator 1769
Site Ref # / Investigator 1952
Site Ref # / Investigator 1964
Site Ref # / Investigator 1832
Site Ref # / Investigator 1784
Site Ref # / Investigator 1783
Site Ref # / Investigator 1827
Site Ref # / Investigator 1947
Site Ref # / Investigator 1831


title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

summary: Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
South Africa
Sweden
United Kingdom
Mexico
Netherlands
Finland
Croatia
France
Poland
Romania
Hungary
Belgium
Spain
Czech Republic
Ukraine


title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability and Efficacy of the CCR1 Antagonist ZK 811752, Given Orally in a Dose of 600 mg Three Times Daily, for the Treatment of Endometriosis Over 12 Weeks

summary: This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.

lead_sponsor: Bayer

location_country:
Sweden
Netherlands
Finland
France
Spain
Denmark
Czech Republic


title: Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

summary: This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

ReferenceType: result

ReferenceCitation: Zacharin M, Szarras-Czapnik M, Racz K, Keller A, Tauber M, Conway G. Growth hormone (GH) treatment improves bone mineral density during transition of GH-deficient patients from adolescence to adulthood. European Society for Paediatric Endocrinology (ESPE) 2007; Country: Finland City: Helsinki

ReferenceCitation: Zacharin M, Keller A, Chanson P, Conway G on behalf of the 1369 GHD to GHDA. Efficacy of two years' growth hormone (GH) treatment on bone mineral density in young adults with childhood-onset GH deficiency. The Endocrine Society Annual Meeting (ENDO) 2007; Country: Canada City: Toronto

ReferenceCitation: Conway G, Scarras-Czapnik M, Racz K, Keller A, Chanson P, Kappelgaard A M, Zacharin M, Hyldstrup L. Direct X-ray radiogrammetry versus dual-energy X-ray absorptiometry: assessment of bone density in young adult with childhood-onset growth hormone deficiency treated with growth hormone. The Endocrine Society Annual Meeting (ENDO) 2008; Country: USA City: San Francisco

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Sweden
Switzerland
France
Poland
Norway
Hungary
Australia
Belgium
Spain
Germany
United Kingdom


lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
Sweden
Germany
Finland
France
Czechia
Bulgaria
Hungary
Belgium
Canada
Korea, Republic of

location_facility: Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset

location_facility: Fakultní nemocnice Ostrava, Spánková laboratoř

location_facility: Acibadem City Clinic Tokuda Hospital EAD

location_facility: Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University

location_facility: Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1

location_facility: 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu

location_facility: 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu

location_facility: Dm Clinical Research / Martin Diagnostic Clinic

location_facility: Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar

location_facility: Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály

location_facility: Clinique beau soleil - Department Sleep and Neurology

location_facility: Hospital UZ Leuven_ Pneumology Department

location_facility: Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory

location_facility: HOSPITAL AZ SINT-JAN_Neurology department

location_facility: University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring

location_facility: 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu

location_facility: 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu

location_facility: Clinical Research Group of St. Petersburgh

location_facility: Fleming Island Center for Clinical Research

location_facility: 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu

location_facility: Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu

location_facility: 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu

location_facility: Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

location_facility: B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu

location_facility: Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg

location_facility: Wesley Neurology Clinic Pc (Multiple Sclerosis)

location_facility: B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu

location_facility: CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique

location_facility: Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck

location_facility: Jacksonville Center for Clinical Research

location_facility: Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)

location_facility: Baptist Health Center for Clinical Research

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin

location_facility: Artemis Institute For Clinical Research - Riverside

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

ipd_sharing: No

title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

summary: The main purpose of this Phase 3 study is to evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.


status: Active, not recruiting

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

location_country:
Italy
Netherlands
France
Japan
Belgium
Spain
Denmark
United States
United Kingdom

acronym:
JAVELIN BRCA/ATM

 JAVELIN BRCA/ATM

location_facility: Hospital of the University of Pennsylvania/Penn Investigational Drug Services

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Memorial Sloan Kettering Cancer Center- Westchester

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B

location_facility: Northside Hospital, Inc. - GCS/Northside

location_facility: Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Washington University School of Medicine

location_facility: Magee-Women's Hospital Women's Cancer Center

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori

location_facility: Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: The Ohio State University Wexner Medical Center

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

location_facility: Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo

location_facility: Washington University Infusion Center Pharmacy

title: A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM

summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.


ReferenceCitation: Okonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.

family: Okonkwo

full_name: Rose Okonkwo

given: Rose

family: Tockhorn-Heidenreich

full_name: Antje Tockhorn-Heidenreich

given: Antje

family: Stroud

full_name: Chad Stroud

given: Chad

family: Paget

full_name: Marie-Ange Paget

given: Marie-Ange

family: Matharu

full_name: Manjit S. Matharu

given: Manjit S.

family: Tassorelli

full_name: Cristina Tassorelli

given: Cristina

journal_name: The Journal of Headache and Pain

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

title: Efficacy of galcanezumab in patients with migraine and history of failure to 3–4 preventive medication categories: subgroup analysis from CONQUER study

ReferenceCitation: Reuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20.

family: Reuter

full_name: Uwe Reuter

given: Uwe

family: Lucas

full_name: Christian Lucas

given: Christian

family: Dolezil

full_name: David Dolezil

given: David

family: Hand

full_name: Austin L. Hand

given: Austin L.

family: Port

full_name: Martha D. Port

given: Martha D.

family: Nichols

full_name: Russell M. Nichols

given: Russell M.

family: Detke

full_name: Holland C. Detke

given: Holland C.

journal_name: Advances in Therapy

ReferenceCitation: Citrome L, Sánchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.

title: Benefit–Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm

ReferenceCitation: Kuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7.

ReferenceCitation: Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w.

ReferenceCitation: Mulleners WM, Kim BK, Láinez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. Epub 2020 Sep 16.

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

location_country:
United States
Netherlands
Germany
France
Czechia
Japan
Hungary
Belgium
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Higashi Sapporo Neurology and Neurosurgery Clinic

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Medical corporation Shinmatsudakai Atago Hospital

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Universitario La Fe de Valencia

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

location_facility: Nowon Eulji Medical Center, Eulji University

title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

summary: The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.


location_country:
Italy
France
Poland
Lithuania
Hungary
Spain
United States

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: East Carolina University; Brody School of Medicine

location_facility: Emory University School of Med; Pediatrics

location_facility: Children'S Mercy Hospital; Pediatric Nephrology

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: Debreceni Egyetem Klinikai Központ; Gyermekklinika

location_facility: Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

title: An Open-Label, Single-Arm, Multicenter Sudy to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

summary: Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.


title: Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial hypercholesterolemia

location_country:
United States
South Africa
Sweden
France
Norway
Australia
Denmark
Canada
Iceland


title: Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

summary: The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

study_type: Observational

time_perspective: Prospective

lead_sponsor: MedImmune LLC

location_country:
United States
Netherlands
Germany
France
Belgium
Canada

location_facility: Atlanta Dermatology, Vein & Research Center, LLC

location_facility: Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt

location_facility: Hospital Saint-Louis Service de Dermatologie 1

location_facility: Hospital Haut Leveque CHU Sud -Service de Dermatologie

location_facility: Capital District Health Authority, QE II Health Sciences Center

location_facility: Washington University, Dermatology Clinical Trials Unit

location_facility: Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)


title: Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

summary:
The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).

The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26.

At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.

status: Terminated

ReferenceType: background

ReferenceCitation: Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. Erratum in: Ann Intern Med. 2011 Sep 20;155(6):408.

ipd_sharing_description: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

lead_sponsor: Grünenthal GmbH

location_country:
United States
France
Australia
New Zealand
Spain
Germany
Korea, Republic of

location_facility: KR008 - Chungnam National University Hospital

location_facility: DE002 - Klinische Forschung Hamburg GmbH

location_facility: DE013 - Klinik und Poliklinik für Neurologie Universitätsmedizin Mainz

location_facility: ES004 - Hospital Universitario Puerto Real Unidad de Anestesiologia

location_facility: KR007 - Konkuk University Medical Center

location_facility: FR004 - Centre Hospitalier Universitaire Amiens Picardie

location_facility: DE005 - Klinische Forschung Schwerin GmbH

location_facility: US030 - Gulfcoast Clinical Research Center

location_facility: AU001 - The Avenue Cardiovascular Centre Level 1 Masada Private Hospital

location_facility: US005 - Hometown Urgent Care and Research

location_facility: DE009 - BAG Anästhesie, Schmerztherapie, Palliativmedizin

location_facility: KR003 - Seoul National University Bundang Hospital

location_facility: ES008 - Hospital Lluis Alcanyis Anesthesiology and Pain Unit

location_facility: KR002 - Seoul National University Hospital

location_facility: US007 - Neurology Offices of South Florida

location_facility: NZ002 - Southern Clinical Trials Group Ltd

location_facility: US047 - The Center for Clinical Research

location_facility: DE010 - Klinische Forschung Hannover Mitte

location_facility: US045 - Holland Center for Family Health

location_facility: US049 - Orange County Research Institute

location_facility: US015 - Tennessee Valley Pain Consultants

location_facility: US038 - DiGiovanna Institute For Medical Education

location_facility: US018 - Carolinas Center for Advanced Management of Pain

location_facility: FR002 - L'Hôpital Privé du Confluent Département d'évaluation et traitement de la douleur

location_facility: ES007 - Hospital Clínico Universitario de Valencia

location_facility: DE006 - Center for Clinical Research Dr. med. I. Schoel

location_facility: FR001 - Centre Hospitalier Universitaire Grenoble Alpes Centre de la douleur

location_facility: ES005 - Hospital Sanitas La Moraleja Pain Unit

location_facility: Nz001 - Bay of Plenty Clinical Trials Unit, Bay of Plenty District Health Board

location_facility: AU002 - Royal North Shore Hospital Michael J Cousins Pain Management and Research Centre

location_facility: US046 - Clinical Research of West Florida, Inc.

location_facility: US044 - The Helm Center for Pain Management

location_facility: ES006 - Hospital Infanta Luisa Rheumatology

location_facility: ES002 - Hospital de la Santa Creu i Sant Pau

location_facility: DE011 - Klinische Forschung Berlin Mitte GmbH

location_facility: US041 - Better Health Clinical Research, Inc.

status_simplified: Unknown


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

location_country:
Malaysia
Greece
Australia
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Lithuania
Norway
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

type: Registry Identifier

title: Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

summary: This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.


title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

summary:
This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.

Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab.

The study will be done in two parts:

Part 1 is to identify the recommended dose to use for treatment.
Part 2 is to find out how well the combination works, and how safe and tolerable it is.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
United States
France
Belgium
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliera Universitaria Senese U.O.C. Immunoterapia Oncologica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario Ramon y Cajal Madrid

location_facility: University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center

location_facility: Tennessee Oncology - Sara Cannon Research Institute

location_facility: Levine Cancer Institute Carolinas Healthcare System


title: A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

summary: The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

ReferenceCitation: Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.

family: Novotny

full_name: E. Novotny

given: E.

family: Renfroe

full_name: B. Renfroe

family: Yardi

full_name: N. Yardi

given: N.

family: Nordli

full_name: D. Nordli

given: D.

family: Ness

full_name: S. Ness

family: Wang

full_name: S. Wang

family: Weber

full_name: T. Weber

given: T.

family: Kurland

full_name: C. L. Kurland

given: C. L.

family: Yuen

full_name: E. Yuen

family: Eerdekens

full_name: M. Eerdekens

given: M.

family: Venkatraman

full_name: L. Venkatraman

given: L.

family: Nye

full_name: J. S. Nye

given: J. S.

family: Ford

full_name: L. Ford

journal_name: Neurology

oa_host_type: repository

ReferenceCitation: Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.

full_name: Seth Ness

given: Seth

family: Todd

full_name: Mike J. Todd

given: Mike J.

full_name: Steven Wang

given: Steven

full_name: Marielle Eerdekens

given: Marielle

full_name: Jeffrey S. Nye

given: Jeffrey S.

title: Adaptive Behavior Outcomes in Infants Treated With Adjunctive Topiramate

ReferenceCitation: Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.

name: Kentucky Neuroscience Research, Louisville, Kentucky

name: Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey

name: Nizam’s Institute of Medical Sciences, Hyderabad, Andhra Pradesh, India

name: Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica, N.V., Beerse, Belgium

title: Long-Term Open-Label Study of Adjunctive Topiramate in Infants With Refractory Partial-Onset Seizures

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Finland
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Hungary
United States
Mexico
Israel
New Zealand
Spain


title: OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

summary: The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

ReferenceCitation: Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Mintz GS, Ben-Yehuda O, McGreevy RJ, Zhang Z, Rapoza RR, West NEJ, Stone GW. Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI. EuroIntervention. 2021 Jan 20;16(13):1092-1099. doi: 10.4244/EIJ-D-20-00501.

family: Ali

full_name: Ziad Ali

given: Ziad

family: Landmesser

full_name: Ulf Landmesser

given: Ulf

family: Karimi Galougahi

full_name: Keyvan Karimi Galougahi

given: Keyvan

family: Maehara

full_name: Akiko Maehara

given: Akiko

family: Matsumura

full_name: Mitsuaki Matsumura

given: Mitsuaki

family: Shlofmitz

full_name: Richard A. Shlofmitz

given: Richard A.

family: Guagliumi

full_name: Giulio Guagliumi

given: Giulio

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Hill

full_name: Jonathan M. Hill

given: Jonathan M.

family: Akasaka

full_name: Takashi Akasaka

given: Takashi

family: Prati

full_name: Francesco Prati

given: Francesco

family: Bezerra

full_name: Hiram G. Bezerra

given: Hiram G.

family: Wijns

full_name: William Wijns

given: William

family: Mintz

full_name: Gary S. Mintz

given: Gary S.

family: Ben-Yehuda

full_name: Ori Ben-Yehuda

given: Ori

family: McGreevy

full_name: Robert J. McGreevy

given: Robert J.

family: Zhang

full_name: Zhen Zhang

given: Zhen

family: Rapoza

full_name: Richard R. Rapoza

given: Richard R.

family: West

full_name: Nick E.J. West

given: Nick E.J.

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

title: Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI – design and rationale of ILUMIEN IV: OPTIMAL PCI

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Sweden
India
Hong Kong
Netherlands
Spain
Germany
Switzerland
France
Japan
Singapore
Belgium
Australia
New Zealand
Portugal
Denmark
Canada
United Kingdom
Taiwan

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

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: University of Massachusetts Medical Center

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: New York Presbyterian Hospital/Columbia University

location_facility: Centennial Heart Cardiovascular Consultants

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: University of California - Davis Medical Center

location_facility: University of North Carolina at Chapel Hill

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

location_facility: Sahlgrenska University Hospital - Gothenburg

location_facility: Cardiovascular Research Institute of Kansas

location_facility: Eastern Heart Clinic - Prince of Wales Hospital

location_facility: The Cardiac & Vascular Institute Research Foundation, LLC

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: University Hospitals Cleveland Medical Center

location_facility: Via Christi Regional Medical Center - St. Francis Campus

location_facility: Montefiore Medical Center - Moses Division


location_country:
Italy
France
Spain
United States
United Kingdom
Canada

location_facility: Nathan S. Kline Institute for Psychiatric Research

location_facility: Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie

location_facility: Vanderbilt University Medical Center; Department of Psychiatry

location_facility: Center for Autism and the Developing Brain

location_facility: Southwest Autism Research & Resource Center

location_facility: Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría

location_facility: Kings College Hospital; Kings Clinical Research Facility

location_facility: RE:Cognition Health; RE:Cognition Health

location_facility: Yale University / Yale-New Haven Hospital

location_facility: ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale

location_facility: Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine

location_facility: Hospital Mutua de Terrassa; Departamento de Psiquiatria

location_facility: Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre

location_facility: ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento

location_facility: UPMC Western Psychiatric Institute and Clinic

location_facility: Queen Elizabeth University Hospital; Clinical Research Facility

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente

location_facility: University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry

location_facility: McGill University Health Centre - Glen Site

location_facility: A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti

location_facility: Western General Hospital; Wellcome Trust CRF

location_facility: Uni of Chicago; Centre For Advanced Medicine

location_facility: University of California at San Francisco

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Hospital Universitario Rio Hortega; Departamento de Psiquiatria

location_facility: Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique

location_facility: AUSL di Piacenza; Psichiatria di Collegamento

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).


title: A Randomized, Subject and Investigator Blinded, Placebo Controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne

summary: The main purpose of this study is to assess preliminary efficacy and safety of LYS006 in patients with moderate to severe inflammatory acne and to determine if LYS006 has an adequate clinical profile for further clinical development.

ipd_sharing: Undecided

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:
United States
Netherlands
France
Czechia
Hungary
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary: A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Peru
Finland
Australia
Russian Federation
Taiwan
India
Pakistan
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Hong Kong
Netherlands
Philippines
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Czechia
New Zealand
Spain


title: A Randomized, Two-Cohort Phase II Study of Two Doses of BMS-275183 Given on a Weekly Schedule in Patients With Pre-Treated Non-Small Cell Lung Cancer

summary: The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Netherlands
France
Belgium
Spain
United States
United Kingdom

location_facility:
Local Insitution
Local Institution


lead_sponsor: Seagen Inc.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

acronym: innovaTV 207

location_facility: Shands Cancer Center / University of Florida

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Ingalls Cancer Care / Ingalls Memorial Hospital

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Seconda Università degli Studi di Napoli, AOU

location_facility: Wake Forest Baptist Medical Center / Wake Forest University

location_facility: Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: University of Alberta / Cross Cancer Institute

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Oncologia Medica, Ospedale Civile S. Maria delle Croci

title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

summary: This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are three parts to this study. In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 4-week cycle.


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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Australia
Spain
Canada
United Kingdom

acronym: PLATforM

location_facility: The Angeles Clinic and Research Institute

location_facility: Georgetown University/Lombardi Cancer Center CERL080AUS67

location_facility: Massachusetts General Hospital Massachusetts Gen. Hospital CC

location_facility: NYU Laura and Isaac Perlmutter Cancer Center Perlmutter Cancer Center

title: A Randomized, Open-label, Phase II Open Platform Study Evaluating the Efficacy and Safety of Novel Spartalizumab (PDR001) Combinations in Previously Treated Unresectable or Metastatic Melanoma

summary: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma


title: Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

summary: The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

ReferenceCitation: Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC β inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

name: From Eli Lilly and Company, Indianapolis, Indiana; the

family: Sheetz

full_name: Matthew J. Sheetz

name: Joslin Diabetes Center, Beetham Eye Institute, Department of Ophthalmology, Harvard University Medical School, Boston, Massachusetts; the

family: Aiello

full_name: Lloyd Paul Aiello

given: Lloyd Paul

name: Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin; the

family: Davis

full_name: Matthew D. Davis

given: Matthew D.

family: Danis

full_name: Ronald Danis

given: Ronald

name: Department of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark; the

family: Bek

full_name: Toke Bek

given: Toke

name: Association for Innovation and Biomedical Research on Light and Image (AIBILI) and the Faculty of Medicine, University of Coimbra, Coimbra, Portugal; and

family: Cunha-Vaz

full_name: Jose Cunha-Vaz

given: Jose

family: Shahri

full_name: Nazila Shahri

given: Nazila

family: Berg

full_name: Paul H. Berg

given: Paul H.

journal_name: Investigative Opthalmology & Visual Science

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: The Effect of the Oral PKC β Inhibitor Ruboxistaurin on Vision Loss in Two Phase 3 Studies

lead_sponsor: Chromaderm, Inc.

location_country:
Italy
Brazil
United States
India
Mexico
Netherlands
Germany
Spain
France
Poland
Australia
Russian Federation
Portugal
Denmark
Canada
United Kingdom
Taiwan

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


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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
South Africa
India
Spain
Germany
France
Japan
Malaysia
Israel
Hungary
Australia
China
Turkey
Denmark
United States
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility:
Investigational Site Number 125
Investigational Site Number 9105
Investigational Site Number 3602
Investigational Site Number 4906
Investigational Site Number 103
Investigational Site Number 4905
Investigational Site Number 9102
Investigational Site Number 9009
Investigational Site Number 4407
Investigational Site Number 8003
Investigational Site Number 9006
Investigational Site Number 3303
Investigational Site Number 8805
Investigational Site Number 8005
Investigational Site Number 8202
Investigational Site Number 3904
Investigational Site Number 9002
Investigational Site Number 128
Investigational Site Number 8001
Investigational Site Number 9109
Investigational Site Number 8804
Investigational Site Number 9003
Investigational Site Number 9104
Investigational Site Number 8602
Investigational Site Number 9004
Investigational Site Number 4402
Investigational Site Number 8604
Investigational Site Number 3305
Investigational Site Number 6004
Investigational Site Number 8807
Investigational Site Number 0140
Investigational Site Number 8603
Investigational Site Number 111
Investigational Site Number 9103
Investigational Site Number 119
Investigational Site Number 3402
Investigational Site Number 8808
Investigational Site Number 9106
Investigational Site Number 8201
Investigational Site Number 2702
Investigational Site Number 4501
Investigational Site Number 110
Investigational Site Number 6104
Investigational Site Number 102
Investigational Site Number 9108
Investigational Site Number 8104
Investigational Site Number 6103
Investigational Site Number 4401
Investigational Site Number 8204
Investigational Site Number 9111
Investigational Site Number 9701
Investigational Site Number 6101
Investigational Site Number 2701
Investigational Site Number 8002
Investigational Site Number 8801
Investigational Site Number 9008
Investigational Site Number 9005
Investigational Site Number 4904
Investigational Site Number 6002
Investigational Site Number 8105
Investigational Site Number 3301
Investigational Site Number 8605
Investigational Site Number 6003
Investigational Site Number 8601

title: ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

summary:
Primary Objective:

-To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes

Secondary Objectives:

To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by:

The frequency of spontaneous bleeding episodes
The frequency of joint bleeding episodes
Health-related quality of life (HRQOL) in patients ≥17 years of age
To determine the frequency of bleeding episodes during the onset period
To determine the safety and tolerability of fitusiran


lead_sponsor: Regeneron Pharmaceuticals

location_country:
Italy
Austria
United States
South Africa
Netherlands
France
Czechia
Greece
Japan
Australia
Canada
Ukraine

location_facility:
Clinical Trial Site
Regeneron Study Site
Clinical Trial Site #1
Rgeneron Study Site
Clinical Trial Site #2

title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

summary:
The primary objectives of the study are:

To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)
To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH

The secondary objectives of the study are:

To evaluate the effect of evinacumab on lipid parameters in patients with HoFH
To evaluabe the effect of evinacumab on lipd parameters in adolescent patients with HoFH
To evaluate the potential development of anti-evinacumab antibodies


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

summary: A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

ReferenceCitation: Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38.

lead_sponsor: Pfizer

location_country:
Italy
United States
Switzerland
Netherlands
France
Singapore
Belgium
Australia
Spain
Canada
United Kingdom


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension

acronym: BUILD 1

summary:
Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.

Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.

The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.

It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.

ReferenceCitation: Raghu G, King TE Jr, Behr J, Brown KK, du Bois RM, Leconte I, Roux S, Swigris J. Quality of life and dyspnoea in patients treated with bosentan for idiopathic pulmonary fibrosis (BUILD-1). Eur Respir J. 2010 Jan;35(1):118-23. doi: 10.1183/09031936.00188108. Epub 2009 Aug 13.

family: Raghu

full_name: G. Raghu

given: G.

family: King

full_name: T. E. King

given: T. E.

family: Behr

full_name: J. Behr

given: J.

family: Brown

full_name: K. K. Brown

given: K. K.

family: du Bois

full_name: R. M. du Bois

given: R. M.

family: Leconte

full_name: I. Leconte

given: I.

family: Roux

full_name: S. Roux

given: S.

family: Swigris

full_name: J. Swigris

journal_name: European Respiratory Journal

evidence: open (via free pdf)

version: acceptedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: King TE Jr, Behr J, Brown KK, du Bois RM, Lancaster L, de Andrade JA, Stähler G, Leconte I, Roux S, Raghu G. BUILD-1: a randomized placebo-controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2008 Jan 1;177(1):75-81. Epub 2007 Sep 27.

lead_sponsor: Actelion

location_country:
Italy
United States
Switzerland
France
Israel
Germany
United Kingdom
Canada

location_facility: National Jewish Medical and Research Center

location_facility: Medizinische Klinik und Poliklinik I Klinikum der Universität München

location_facility: University of Michigan Health System - Division of Pulmonary & Critical Care Medicine

location_facility: University of Alabama at Birmingham - Pulmonary Division

location_facility: University of Iowa Hospitals & Clinics - Department of Internal Medicine

location_facility: Notre-Dame Hospital - Clinique du Thorax

location_facility: David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine

location_facility: University of Washington - Division of Pulmonary & Critical Care Medicine

location_facility: Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg

location_facility: Section of Respiratory Diseases - Policlinico Le Scotte - Siena University

location_facility: University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine

location_facility: Médecine Spécialisée Aigüe - CHU Grenoble

location_facility: University of British Columbia - St. Paul's Hospital

location_facility: University of California - Ambulatory Care Center


title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006

summary:
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

ReferenceCitation: van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12.

lead_sponsor: Sanofi

location_country:
Italy
Austria
Brazil
South Africa
Sweden
United Kingdom
Netherlands
Germany
Finland
France
Poland
Norway
Australia
Belgium
New Zealand
Spain
Denmark
United States
Czech Republic
Canada

location_facility: The University of Texas Health Center at Tyler

location_facility: William Beaumont Hospital / Clinical Research Center

location_facility: Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec

location_facility: St. Joseph Mercy - Oakland Clinical Research Office

location_facility: Melbourne Internal Medicine Associates (MIMA)

location_facility: Melbourne Internal Medical Associates (MIMA)

location_facility: Lovelace Sandia Health Systems, Clinical Thrombosis Center

location_facility: Pulmonary Specialists/Spokane Respiratory Consultants

location_facility: Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office

location_facility: Pulmonary Associates of Fredericksburg, Inc.

location_facility: Scott and White Memorial Hospital and Clinic