title: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

lead_sponsor: Clovis Oncology, Inc.

ReferenceCitation: Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17. Review.

ipd_sharing_description:
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

location_country:
Denmark
Spain
Ireland
Italy
Australia
United Kingdom
Canada
United States
France
Israel
Belgium
Germany

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Equipe de Recherche Clinique, Département d'Oncologie/Hématologie

location_facility: Premier Urology Associates dba/AdvanceMed Research

location_facility: IRCCS Istituto Nazionale dei Tumori (INT)

location_facility: Consultants in Medical Oncology Hematology

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Barwon Health, University Hospital Geelong

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Kaiser Permanente Medical Center (Vallejo)

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Gemeinschaftspraxis fur Hamatologie & Onkologie

location_facility: London Health Science Center - Victoria Hospital

location_facility: University of Modena and Reggio Emilia Medical Oncology

location_facility: Hospital General Universitario de Guadalajara

location_facility: Juravinski Cancer Centre Hamilton Health Services

location_facility: Weill Cornell Medical College/NewYork-Presbyterian Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Florida Health Cancer Center

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Hospital Universitario Central de Asturias

location_facility: Santa Chiara Hospital, Dept Medical Oncology

summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.


type: EudraCT Number

title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

summary: The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

ReferenceType: derived

ReferenceCitation: Chounta V, Snedecor SJ, Wu S, Van de Velde N. Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection. BMC Infect Dis. 2022 May 4;22(1):428. doi: 10.1186/s12879-022-07243-3.

ReferenceCitation: Rizzardini G, Overton ET, Orkin C, Swindells S, Arasteh K, Górgolas Hernández-Mora M, Pokrovsky V, Girard PM, Oka S, Andrade-Villanueva JF, Richmond GJ, Baumgarten A, Masiá M, Latiff G, Griffith S, Harrington CM, Hudson KJ, St Clair M, Talarico CL, Patel P, Cutrell A, Van Eygen V, D'Amico R, Mrus JM, Wu S, Ford SL, Chow K, Roberts J, Wills A, Walters N, Vanveggel S, Van Solingen-Ristea R, Crauwels H, Smith KY, Spreen WR, Margolis DA. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506. doi: 10.1097/QAI.0000000000002466.

ReferenceCitation: Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masiá M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Russian Federation
Australia
Argentina
Canada
Sweden
Korea, Republic of
United States
France
South Africa
Mexico
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

summary: The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.

ReferenceCitation: Orkin C, Arasteh K, Górgolas Hernández-Mora M, Pokrovsky V, Overton ET, Girard PM, Oka S, Walmsley S, Bettacchi C, Brinson C, Philibert P, Lombaard J, St Clair M, Crauwels H, Ford SL, Patel P, Chounta V, D'Amico R, Vanveggel S, Dorey D, Cutrell A, Griffith S, Margolis DA, Williams PE, Parys W, Smith KY, Spreen WR. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020 Mar 19;382(12):1124-1135. doi: 10.1056/NEJMoa1909512. Epub 2020 Mar 4.

ReferenceCitation: Jeffrey JL, St Clair M, Wang P, Wang C, Li Z, Beloor J, Talarico C, Fridell R, Krystal M, White CT, Griffith S, D'Amico R, Smith K, Van Eygen V, Vingerhoets J, Vandermeulen K, Spreen W, van Lunzen J. Impact of Integrase Sequences from HIV-1 Subtypes A6/A1 on the In Vitro Potency of Cabotegravir or Rilpivirine. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0170221. doi: 10.1128/AAC.01702-21. Epub 2022 Jan 3.

ReferenceCitation: Orkin C, Bernal Morell E, Tan DHS, Katner H, Stellbrink HJ, Belonosova E, DeMoor R, Griffith S, Thiagarajah S, Van Solingen-Ristea R, Ford SL, Crauwels H, Patel P, Cutrell A, Smith KY, Vandermeulen K, Birmingham E, St Clair M, Spreen WR, D'Amico R. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021 Nov;8(11):e668-e678. doi: 10.1016/S2352-3018(21)00184-3. Epub 2021 Oct 14.

ReferenceCitation: Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, Degen O, Garcia JG, Morell EB, Tan DHS, D'Amico R, Dorey D, Griffith S, Thiagarajah S, St Clair M, Van Solingen-Ristea R, Crauwels H, Ford SL, Patel P, Chounta V, Vanveggel S, Cutrell A, Van Eygen V, Vandermeulen K, Margolis DA, Smith KY, Spreen WR. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021 Apr;8(4):e185-e196. doi: 10.1016/S2352-3018(20)30340-4. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.

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

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
United States
France
South Africa
Japan
Germany


status: Recruiting

intervention_type: Biological

acronym:
BAX 111 rVWF in Pediatrics

 BAX 111 rVWF dans la population pédiatrique

title: A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease

lead_sponsor: Baxalta now part of Shire

source: euctr

design_allocation: Non-Randomized

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

enrollment_type: Anticipated

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
Ukraine
France
United States
Turkey
Belgium
Germany
Czechia

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital General Universitario de Alicante

location_facility: University of Florida College of Medicine

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Texas Children's Cancer and Hematology Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: St. Jude Affiliate Clinic at Novant Health

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Comprehensive Center for Bleeding Disorders

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Bleeding and Clotting Disorders Institute

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Comprehensive Cancer Center of Wake Forest Unversity

summary:
The main aim of the study is to check effectiveness, side effects, and tolerability of recombinant von Willebrand Factor (rVWF), with or without ADVATE, in the treatment and control of nonsurgical bleeding events in pediatric participants (less than (<)18 years of age) with severe hereditary von Willebrand disease (VWD).

The participants will be treated with rVWF for 12-18 months. Their von Willebrand Disease will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be followed up at clinics or over telephone calls.


title: A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

summary: This 6-month extension study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) in subjects with Dementia with Lewy bodies (DLB) who have participated in the double-blind, placebo-controlled, lead-in study RVT-101-2001.

status: Terminated

study_completion_date_type: Actual

lead_sponsor: Axovant Sciences Ltd.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Netherlands

status_simplified: Unknown


title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents

summary: A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual subject participation will vary. Subjects may continue to receive treatment for as long as they continue to benefit.

status: Completed

ipd_sharing: No

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Canada
Sweden
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Onkologická klinika Všeobecná fakultní nemocnice v Praze a 1

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: West Virginia University Mary Babb Randolph Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Maisonneuve-Rosemont Hôpital Service d'Hematologie et d'Oncologie Medicale

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

intervention_type: Other

status_simplified: Completed


title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

acronym: TRuST

summary: This rollover study will provide continuing availability to tazemetostat as a single agent to subjects who have completed their participation in an antecedent tazemetostat study (either with monotherapy or combination therapy).

lead_sponsor: Epizyme, Inc.

location_country:
Poland
United Kingdom
Australia
Ukraine
United States
France
Belgium

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej

location_facility: S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"

location_facility: Oncology and Haematology Clinical Trials Unit


title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

summary: The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

ReferenceCitation: Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Japan
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia

location_facility: California Pacific Medical Center Research Institute


title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

ReferenceCitation: Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

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

lead_sponsor: Pfizer

location_country:
Germany
United States
Israel
France

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

location_facility: University of South Florida Carol and Frank Morsani Center for Advanced Health Care

location_facility: University of South Florida Parkinson's Disease and Movement Disorders Center

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: St Joseph's Hospital and Medical Center, Barrow Neurology Clinics

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of South Florida Faculty Office Building

location_facility: Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders

location_facility: University of Toledo, Gardner-McMaster Parkinson Center


title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

summary: This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

ReferenceCitation: Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.

ipd_sharing_description: The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

lead_sponsor: Biosensors Europe SA

location_country:
Denmark
United Kingdom
Italy
Canada
United States
France
Germany

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Columbia University Medical Center/New York Presbyterian Hospital

location_facility: CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Novant Health Heart and Vascular Institute

location_facility: Centre Hospitalier de l'université de Montréal

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Royal Bournemouth Hospital, Dorset Heart Centre

location_facility: The University of Ottawa Heart Institute

location_facility: Penn State - Milton S. Hershey Medical Center

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Weill Cornell Medical College-New York Presbyterian

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec

location_facility: Service de Cardiologie Interventionnelle - Pôle Santé République

location_facility: Pinnacle Health Cardiovascular Institute

intervention_type: Device


title: INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

ReferenceCitation: Behr J, Kolb M, Song JW, Luppi F, Schinzel B, Stowasser S, Quaresma M, Martinez FJ. Nintedanib and Sildenafil in Patients with Idiopathic Pulmonary Fibrosis and Right Heart Dysfunction. A Prespecified Subgroup Analysis of a Double-Blind Randomized Clinical Trial (INSTAGE). Am J Respir Crit Care Med. 2019 Dec 15;200(12):1505-1512. doi: 10.1164/rccm.201903-0488OC.

ReferenceCitation: Kolb M, Raghu G, Wells AU, Behr J, Richeldi L, Schinzel B, Quaresma M, Stowasser S, Martinez FJ; INSTAGE Investigators. Nintedanib plus Sildenafil in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Nov 1;379(18):1722-1731. doi: 10.1056/NEJMoa1811737. Epub 2018 Sep 15.

location_country:
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Korea, Republic of
United States
France
India
Belgium
Japan
Germany

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Hospital General Universitario de Valencia

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: University of Florida College of Medicine

location_facility: Az. Ospedaliera Universitaria Polic.Tor Vergata

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Sanjivani Superspeciality Hospital Pvt. Ltd.

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Nuevo Hospital Civil de Guadalajara DR. JUAN I. MENCHACA

location_facility: University of Texas Southwestern Medical Center

location_facility: National Hospital Organization Himeji Medical Center

summary: To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.


title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

acronym: STELLAR

summary: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

lead_sponsor: Orbus Therapeutics, Inc.

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

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Columbia University Medical Center, The Neurological Institute

location_facility: Louisiana State University Health Sciences Center New Orleans

location_facility: Fondazione IRCCS - Instituto Neurologico Carlo Besta

location_facility: Texas Oncology Austin Brain Tumor Center

location_facility: University of California Irvine Medical Center

location_facility: Dana Farber Cancer Institute, Brigham and Women's Hospital

location_facility: Cliniques Universitaires UCL De Mont-Godinne

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: University of California San Francisco Medical Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: OhioHealth Research and Innovation Institute

location_facility: University of Kentucky Chandler Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Hôpital Pierre Wertheimer - Hospices Civils de Lyon

location_facility: University of North Carolina - Chapel Hill

location_facility: Edinburgh Cancer Centre - Western General Hospital

location_facility: Institut de Cancerologie de l'Ouest - Angers

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: The Cleveland Clinic, Richard E. Jacobs Health Center


acronym: REMARC

title: Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line

lead_sponsor: The Lymphoma Academic Research Organisation

ReferenceCitation: Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CT(†). Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3.

ReferenceCitation: Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, López-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.

location_country: Poland Portugal Spain Austria Australia Switzerland France Israel Belgium

location_facility: LKH Leoben-Eisenerz Department für Hämato-Onkologie

location_facility: Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny

location_facility: Klinika Hematologii Collegium Medicum UJ

location_facility: Complejo Hospitalario Universitario de A Coruna

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Universite Catholique de Louvain Mont Godinne

location_facility: Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner

location_facility: Hospital Général Universitario Gregorio Maranon

location_facility: Landeskrankenhaus Steyr - Innere Medizin II

location_facility: Medizinische Universität Innsbruck für Innere Medizin

location_facility: Flinders Medical Centre - Repatriation General Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hôpital des instructions des Armées PERCY

location_facility: AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un

location_facility: SPZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: Albury Base Hospital/Murray Valley Private Hospital

location_facility: Instituto Português de Oncologia de Lisboa de Francisco Gentil

location_facility: AZ Groeninge - Campus Maria s Voorzienigheid

location_facility: Hopital Universitario Virgen de la Arrixaca

location_facility: Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii

location_facility: Universite Catholique de Louvain Saint Luc

location_facility: Frankston Hospital Monash Medical Centre

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Mater Misericordiae Hospital - Calvary Mater NewCastle

location_facility: Universitätklinik der PMU Salzburg - Für Innere Medizin III

summary:
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy

For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.


title: Phase III Trial of IV Vinflunine Versus an Alkylating Agent in Patients With Metastatic Breast Cancer Previously Treated With or Resistant to an Anthracycline, a Taxane, an Antimetabolite, and a Vinca-alkaloid (Study L00070 IN 308 B0)

lead_sponsor: Pierre Fabre Medicament

ReferenceCitation: Cortes J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051.

location_country:
Taiwan
Portugal
Belarus
Spain
Italy
Austria
Russian Federation
United Kingdom
Argentina
Ukraine
France
South Africa
Belgium
Germany

summary: In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.


acronym: EUROMAX

title: Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)

lead_sponsor: The Medicines Company

ReferenceCitation: Huber K, Ducrocq G, Hamm CW, van 't Hof A, Lapostolle F, Coste P, Gordini G, Steinmetz J, Verheugt FWA, Adgey J, Nibbe L, Kaniĉ V, Clemmensen P, Zeymer U, Bernstein D, Prats J, Deliargyris EN, Gabriel Steg P. Early clinical outcomes as a function of use of newer oral P2Y(12) inhibitors versus clopidogrel in the EUROMAX trial. Open Heart. 2017 Nov 28;4(2):e000677. doi: 10.1136/openhrt-2017-000677. eCollection 2017.

ReferenceCitation: Fabris E, Kilic S, Van't Hof AWJ, Ten Berg J, Ayesta A, Zeymer U, Hamon M, Soulat L, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. One-Year Mortality for Bivalirudin vs Heparins Plus Optional Glycoprotein IIb/IIIa Inhibitor Treatment Started in the Ambulance for ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the EUROMAX Randomized Clinical Trial. JAMA Cardiol. 2017 Jul 1;2(7):791-796. doi: 10.1001/jamacardio.2016.5975.

ReferenceCitation: Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10.

ReferenceCitation: Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272.

ReferenceCitation: Kilic S, Van't Hof AW, Ten Berg J, Lopez AA, Zeymer U, Hamon M, Soulat L, Bernstein D, Deliargyris EN, Steg PG. Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial. Int J Cardiol. 2016 May 15;211:119-23. doi: 10.1016/j.ijcard.2016.02.131. Epub 2016 Mar 3.

ReferenceCitation: Hamon M, Coste P, Van't Hof A, Ten Berg J, Clemmensen P, Tabone X, Benamer H, Kristensen SD, Cavallini C, Marzocchi A, Hamm C, Kanic V, Bernstein D, Anthopoulos P, Deliargyris EN, Steg PG. Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002049. doi: 10.1161/CIRCINTERVENTIONS.114.002049.

ReferenceCitation: Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Généreux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029.

ReferenceCitation: Steg PG, van 't Hof A, Clemmensen P, Lapostolle F, Dudek D, Hamon M, Cavallini C, Gordini G, Huber K, Coste P, Thicoipe M, Nibbe L, Steinmetz J, Ten Berg J, Eggink GJ, Zeymer U, Campo dell' Orto M, Kanic V, Deliargyris EN, Day J, Schuette D, Hamm CW, Goldstein P. Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): an international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention. Am Heart J. 2013 Dec;166(6):960-967.e6. doi: 10.1016/j.ahj.2013.08.025. Epub 2013 Nov 7.

ReferenceCitation: Steg PG, van 't Hof A, Hamm CW, Clemmensen P, Lapostolle F, Coste P, Ten Berg J, Van Grunsven P, Eggink GJ, Nibbe L, Zeymer U, Campo dell' Orto M, Nef H, Steinmetz J, Soulat L, Huber K, Deliargyris EN, Bernstein D, Schuette D, Prats J, Clayton T, Pocock S, Hamon M, Goldstein P; EUROMAX Investigators. Bivalirudin started during emergency transport for primary PCI. N Engl J Med. 2013 Dec 5;369(23):2207-17. doi: 10.1056/NEJMoa1311096. Epub 2013 Oct 30.

location_country:
Denmark
Poland
Slovenia
Italy
Austria
Netherlands
Czech Republic
France
Germany

location_facility: Oddzial Polskiej-Amerikanskiej Kliniki Serca

location_facility: Service Gelderland-Zuid Klinisch Geneesmiddelonderzoek Klinsche Farmacie Afd Klinsche Farmacie

location_facility: Medizinische Hochschule Hannover, Carl Neuberg Str. 1

location_facility: Centre Hospitalier De Vienne Centre Hospitalier Lucien Hussel

location_facility: Jagiellonian University Medical College,

location_facility: Regional Ambulance Service Gelderland Zuid

location_facility: Splosna Bolnisnica Novo Mesto/ Community Hospital Novo Mesto, Smihelska Cesta 1

location_facility: Herzzentrum Duisburg, Klinik Fur Kardiologie And Angiologie

location_facility: Szpital Powiatowy W Sedziszowie Malopolskim

location_facility: Cardiologic Hospital - Coronary Care Unit, University of Bordeaux

location_facility: Sana Klinikum Lichtenberg Oskar Ziethen Krankenhaus, Fanningerstrasse 32

location_facility: Akutlaegebil Kobenhavn, Hc Andersens Boulevard 23

location_facility: Charite Universitatsmedizin Berlin Campus Virchow-Klinikum

location_facility: Tav Trial Team, Isala Klinieken Ioc Weezenlanden Afd

location_facility: Hospital Avicenne, Pharmacie -Gestion Des Essais Cliniques

location_facility: Oddzial Kardiologii Al.Lotnikow Polskich 18

location_facility: Regional Ambulance Service Gelderland-Zuid Distributiecentrum

location_facility: Ch Sud Francilien - Site Corbeil, Pharmacie

location_facility: Centre Hospitalier Universitaire De Caen

location_facility: Zdravstveni Dom Dr. Adolfa Drolca Maribor

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Szpital Specjalistyczny Im Szpitalny Oddzial Ratunkowy

location_facility: Universitatsklinikum Benjamin Franklin, Hindenburgdamm 30

location_facility: Polsko-Amerykanskie Kliniki Serca, Szpital Powiatowy

location_facility: Splosna Bolnisnica Ptuj, Interni Odelek, Potrceva Cesta 23

location_facility: Emergency Rescue & Mobile Als Unit, Lanciarini Pub

location_facility: Samodzielna Publiczna Stacja Pogotowia Ratunkowego, Samodzielna Publiczna Stacja Pogotowia Ratunkowego W Niepolomicach

location_facility: Helios Klinik Der Universitat Witten Herdecke

location_facility: Chu De Toulouse - Hopital Paule De Viguier

location_facility: Stadtisches Klinikum Luneburg, Bogelstr. 1

location_facility: Chi Le Raincy - Montfermeil Site De Montfermeil

location_facility: Regional Ambulance Service Gelderland Midden

location_facility: Hopital Andre Mignot - Centre Hospitalier De Versailles

location_facility: Cwz Klinisch Geneesmiddelonderzoek Klinische

location_facility: Spzoz Szpital Im. J.Dietla W Krynicy Zdroj

location_facility: Szpital Powiatowy Im. Jana Pawla Ii W Kolbuszowej

summary: To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.


title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.

summary: This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.

ReferenceCitation: Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of


title: Multinational Ambispective Study of the Clinical Management and Burden of Bipolar Disorder (WAVE bd Study)

acronym: WAVE bd

summary: This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

ReferenceCitation: Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, Moreno-Manzanaro M, Gonzalez MA, Bellivier F. Clinical management and burden of bipolar disorder: results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol. 2013 Sep;16(8):1719-32. doi: 10.1017/S1461145713000278. Epub 2013 May 13.

ReferenceCitation: Vieta E, Blasco-Colmenares E, Figueira ML, Langosch JM, Moreno-Manzanaro M, Medina E; WAVE-bd Study Group. Clinical management and burden of bipolar disorder: a multinational longitudinal study (WAVE-bd study). BMC Psychiatry. 2011 Apr 11;11:58. doi: 10.1186/1471-244X-11-58.

lead_sponsor: AstraZeneca

location_country: Brazil Portugal Romania Austria Ukraine Venezuela France Turkey Belgium Germany


title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

lead_sponsor: Genentech, Inc.

type: Other Identifier

ReferenceCitation: Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

ReferenceCitation: Cheson BD, Chua N, Mayer J, Dueck G, Trněný M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.

ReferenceCitation: Sehn LH, Chua N, Mayer J, Dueck G, Trněný M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
Canada
United Kingdom
Switzerland
Sweden
United States
France
Belgium
Germany
Czechia

location_facility: Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III

location_facility: University of Florida; Division of Hematology/Oncology

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: I Interni klinika; Vseobecna fakultni nemocnice

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Republican Clinical Hospital n.a. Baranov; Haematology

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Barts & London School of Med; Medical Oncology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Georgetown University Medical Center Lombardi Cancer Center

summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).


title: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

ReferenceCitation: Schrieks IC, Nozza A, Stähli BE, Buse JB, Henry RR, Malmberg K, Neal B, Nicholls SJ, Rydén L, Mellbin L, Svensson A, Wedel H, Weichert A, Lincoff AM, Tardif JC, Grobbee DE, Schwartz GG. Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome. Diabetes Care. 2018 Aug;41(8):1792-1800. doi: 10.2337/dc18-0158. Epub 2018 Jun 14.

ReferenceCitation: Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators. Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial. JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321.

ReferenceCitation: Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE. Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial. Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Poland
Russian Federation
Australia
Argentina
India
Mexico
Malaysia
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Ireland
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Grenada
Netherlands

summary: This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.


title: A Double-blind, Comparative, Superiority, Multi-centre Investigation Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

summary: Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

lead_sponsor: Molnlycke Health Care AB

location_country:
Germany
France
Czech Republic
Netherlands

location_facility: Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie

location_facility: CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies

location_facility: Dermatovenerologická klinike, Univerzita Karlova

location_facility: Hôpital privé d'Antony Service de Dermatologie

location_facility: Dermatovenerologická klinika, University Hospital Bohunice,

location_facility: Service de Dermatologie, Centre Hospitalier Regional Universitaire

location_facility: Hôpital Albert Michallon Service de médecine vasculaire

location_facility: Fakultní nemocnice U svate Anny, St. Anne´s University Hospital

location_facility: Maison de Santé Protestante de Bordeaux-Bagatelle

location_facility: Universität klinikum Jena, Klinik für dermatologie und dermatologische

location_facility: chirugické oddělení, Fakultní nemocnice Královské Vinohrady

location_facility: Dermatology Department, University Hospital, Hopital Sud

location_facility: Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -

location_facility: Centre Hospitalier le Mans Service de Dermatologie

location_facility: Cabinet d'Angiologie, 1 bis rue de Salgareda

location_facility: Hopital Robert Debré Service de Dermatologie

location_facility: Polyclinique de Picardie Service d'Angiologie Phlébologie

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Hopital Beauregard / Secrétariat de Dermatologie


acronym: PARADIGM-HF

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21.

ReferenceCitation: Toenges G, Mütze T, Jahn-Eimermacher A. A comparison of semiparametric approaches to evaluate composite endpoints in heart failure trials. Stat Med. 2021 Nov 20;40(26):5702-5724. doi: 10.1002/sim.9149. Epub 2021 Jul 30.

ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Køber LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

ReferenceCitation: Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.

ReferenceCitation: Ehteshami-Afshar S, Mooney L, Dewan P, Desai AS, Lang NN, Lefkowitz MP, Petrie MC, Rizkala AR, Rouleau JL, Solomon SD, Swedberg K, Shi VC, Zile MR, Packer M, McMurray JJV, Jhund PS, Hawkins NM. Clinical Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease: Insights From PARADIGM-HF. J Am Heart Assoc. 2021 Feb 16;10(4):e019238. doi: 10.1161/JAHA.120.019238. Epub 2021 Jan 30.

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rørth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Böhm M, Desai AS, Dickstein K, Køber LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

ReferenceCitation: Dewan P, Rørth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Køber L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum in: Circ Heart Fail. 2020 Jan;13(1):e000036.

ReferenceCitation: Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.

ReferenceCitation: Selvaraj S, Claggett B, Pozzi A, McMurray JJV, Jhund PS, Packer M, Desai AS, Lewis EF, Vaduganathan M, Lefkowitz MP, Rouleau JL, Shi VC, Zile MR, Swedberg K, Solomon SD. Prognostic Implications of Congestion on Physical Examination Among Contemporary Patients With Heart Failure and Reduced Ejection Fraction: PARADIGM-HF. Circulation. 2019 Oct 22;140(17):1369-1379. doi: 10.1161/CIRCULATIONAHA.119.039920. Epub 2019 Sep 12.

ReferenceCitation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.

ReferenceCitation: Balmforth C, Simpson J, Shen L, Jhund PS, Lefkowitz M, Rizkala AR, Rouleau JL, Shi V, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJV. Outcomes and Effect of Treatment According to Etiology in HFrEF: An Analysis of PARADIGM-HF. JACC Heart Fail. 2019 Jun;7(6):457-465. doi: 10.1016/j.jchf.2019.02.015. Epub 2019 May 8.

ReferenceCitation: Myhre PL, Vaduganathan M, Claggett B, Packer M, Desai AS, Rouleau JL, Zile MR, Swedberg K, Lefkowitz M, Shi V, McMurray JJV, Solomon SD. B-Type Natriuretic Peptide During Treatment With Sacubitril/Valsartan: The PARADIGM-HF Trial. J Am Coll Cardiol. 2019 Mar 26;73(11):1264-1272. doi: 10.1016/j.jacc.2019.01.018. Epub 2019 Mar 4.

ReferenceCitation: Zile MR, O'Meara E, Claggett B, Prescott MF, Solomon SD, Swedberg K, Packer M, McMurray JJV, Shi V, Lefkowitz M, Rouleau J. Effects of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFrEF. J Am Coll Cardiol. 2019 Feb 26;73(7):795-806. doi: 10.1016/j.jacc.2018.11.042.

ReferenceCitation: Bouabdallaoui N, Claggett B, Zile MR, McMurray JJV, O'Meara E, Packer M, Prescott MF, Swedberg K, Solomon SD, Rouleau JL; PARADIGM-HF Investigators and Committees. Growth differentiation factor-15 is not modified by sacubitril/valsartan and is an independent marker of risk in patients with heart failure and reduced ejection fraction: the PARADIGM-HF trial. Eur J Heart Fail. 2018 Dec;20(12):1701-1709. doi: 10.1002/ejhf.1301. Epub 2018 Sep 11.

ReferenceCitation: O'Meara E, Prescott MF, Claggett B, Rouleau JL, Chiang LM, Solomon SD, Packer M, McMurray JJV, Zile MR. Independent Prognostic Value of Serum Soluble ST2 Measurements in Patients With Heart Failure and a Reduced Ejection Fraction in the PARADIGM-HF Trial (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure). Circ Heart Fail. 2018 May;11(5):e004446. doi: 10.1161/CIRCHEARTFAILURE.117.004446.

ReferenceCitation: Packer M, Claggett B, Lefkowitz MP, McMurray JJV, Rouleau JL, Solomon SD, Zile MR. Effect of neprilysin inhibition on renal function in patients with type 2 diabetes and chronic heart failure who are receiving target doses of inhibitors of the renin-angiotensin system: a secondary analysis of the PARADIGM-HF trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):547-554. doi: 10.1016/S2213-8587(18)30100-1. Epub 2018 Apr 13.

ReferenceCitation: Chandra A, Lewis EF, Claggett BL, Desai AS, Packer M, Zile MR, Swedberg K, Rouleau JL, Shi VC, Lefkowitz MP, Katova T, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2018 Jun 1;3(6):498-505. doi: 10.1001/jamacardio.2018.0398.

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverría LE, Gómez EA, Abraham WT, Dickstein K, Køber L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11). pii: e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rørth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Køber L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10). pii: e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

ReferenceCitation: Lewis EF, Claggett BL, McMurray JJV, Packer M, Lefkowitz MP, Rouleau JL, Liu J, Shi VC, Zile MR, Desai AS, Solomon SD, Swedberg K. Health-Related Quality of Life Outcomes in PARADIGM-HF. Circ Heart Fail. 2017 Aug;10(8). pii: e003430. doi: 10.1161/CIRCHEARTFAILURE.116.003430.

ReferenceCitation: Zile MR, Claggett BL, Prescott MF, McMurray JJ, Packer M, Rouleau JL, Swedberg K, Desai AS, Gong J, Shi VC, Solomon SD. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2425-2436. doi: 10.1016/j.jacc.2016.09.931.

ReferenceCitation: Nadruz W Jr, Claggett BL, McMurray JJ, Packer M, Zile MR, Rouleau JL, Desai AS, Swedberg K, Lefkowitz M, Shi VC, Prescott MF, Solomon SD. Impact of Body Mass Index on the Accuracy of N-Terminal Pro-Brain Natriuretic Peptide and Brain Natriuretic Peptide for Predicting Outcomes in Patients With Chronic Heart Failure and Reduced Ejection Fraction: Insights From the PARADIGM-HF Study (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial). Circulation. 2016 Nov 29;134(22):1785-1787.

ReferenceCitation: Desai AS, Vardeny O, Claggett B, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Zile MR, Lefkowitz M, Shi V, Solomon SD. Reduced Risk of Hyperkalemia During Treatment of Heart Failure With Mineralocorticoid Receptor Antagonists by Use of Sacubitril/Valsartan Compared With Enalapril: A Secondary Analysis of the PARADIGM-HF Trial. JAMA Cardiol. 2017 Jan 1;2(1):79-85. doi: 10.1001/jamacardio.2016.4733.

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Effects of Sacubitril/Valsartan in the PARADIGM-HF Trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) According to Background Therapy. Circ Heart Fail. 2016 Sep;9(9). pii: e003212. doi: 10.1161/CIRCHEARTFAILURE.116.003212.

ReferenceCitation: Solomon SD, Claggett B, Packer M, Desai A, Zile MR, Swedberg K, Rouleau J, Shi V, Lefkowitz M, McMurray JJV. Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Oct;4(10):816-822. doi: 10.1016/j.jchf.2016.05.002. Epub 2016 Jul 6.

ReferenceCitation: Kristensen SL, Martinez F, Jhund PS, Arango JL, Bĕlohlávek J, Boytsov S, Cabrera W, Gomez E, Hagège AA, Huang J, Kiatchoosakun S, Kim KS, Mendoza I, Senni M, Squire IB, Vinereanu D, Wong RC, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Packer M, McMurray JJ. Geographic variations in the PARADIGM-HF heart failure trial. Eur Heart J. 2016 Nov 1;37(41):3167-3174. Epub 2016 Jun 28.

ReferenceCitation: Desai AS, Solomon S, Claggett B, McMurray JJ, Rouleau J, Swedberg K, Zile M, Lefkowitz M, Shi V, Packer M. Factors Associated With Noncompletion During the Run-In Period Before Randomization and Influence on the Estimated Benefit of LCZ696 in the PARADIGM-HF Trial. Circ Heart Fail. 2016 Jun;9(6). pii: e002735. doi: 10.1161/CIRCHEARTFAILURE.115.002735.

ReferenceCitation: Okumura N, Jhund PS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, Packer M, McMurray JJ; PARADIGM-HF Investigators and Committees*. Importance of Clinical Worsening of Heart Failure Treated in the Outpatient Setting: Evidence From the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial (PARADIGM-HF). Circulation. 2016 Jun 7;133(23):2254-62. doi: 10.1161/CIRCULATIONAHA.115.020729. Epub 2016 Apr 20.

ReferenceCitation: Solomon SD, Claggett B, Desai AS, Packer M, Zile M, Swedberg K, Rouleau JL, Shi VC, Starling RC, Kozan Ö, Dukat A, Lefkowitz MP, McMurray JJ. Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Trial. Circ Heart Fail. 2016 Mar;9(3):e002744. doi: 10.1161/CIRCHEARTFAILURE.115.002744.

ReferenceCitation: Kristensen SL, Preiss D, Jhund PS, Squire I, Cardoso JS, Merkely B, Martinez F, Starling RC, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial. Circ Heart Fail. 2016 Jan;9(1). pii: e002560. doi: 10.1161/CIRCHEARTFAILURE.115.002560.

ReferenceCitation: Simpson J, Jhund PS, Silva Cardoso J, Martinez F, Mosterd A, Ramires F, Rizkala AR, Senni M, Squire I, Gong J, Lefkowitz MP, Shi VC, Desai AS, Rouleau JL, Swedberg K, Zile MR, McMurray JJV, Packer M, Solomon SD; PARADIGM-HF Investigators and Committees. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J Am Coll Cardiol. 2015 Nov 10;66(19):2059-2071. doi: 10.1016/j.jacc.2015.08.878.

ReferenceCitation: Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4. Review.

ReferenceCitation: Jhund PS, Fu M, Bayram E, Chen CH, Negrusz-Kawecka M, Rosenthal A, Desai AS, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, McMurray JJ, Packer M; PARADIGM-HF Investigators and Committees. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015 Oct 7;36(38):2576-84. doi: 10.1093/eurheartj/ehv330. Epub 2015 Jul 31.

ReferenceCitation: Desai AS, McMurray JJ, Packer M, Swedberg K, Rouleau JL, Chen F, Gong J, Rizkala AR, Brahimi A, Claggett B, Finn PV, Hartley LH, Liu J, Lefkowitz M, Shi V, Zile MR, Solomon SD. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015 Aug 7;36(30):1990-7. doi: 10.1093/eurheartj/ehv186. Epub 2015 May 28.

ReferenceCitation: McMurray J, Packer M, Desai A, Gong J, Greenlaw N, Lefkowitz M, Rizkala A, Shi V, Rouleau J, Solomon S, Swedberg K, Zile MR, Andersen K, Arango JL, Arnold M, Bĕlohlávek J, Böhm M, Boytsov S, Burgess L, Cabrera W, Chen CH, Erglis A, Fu M, Gomez E, Gonzalez A, Hagege AA, Katova T, Kiatchoosakun S, Kim KS, Bayram E, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires F, Refsgaard J, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire I, Starling RC, Vinereanu D, Teerlink JR, Wong R; PARADIGM-HF Committees and Investigators. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure. Eur Heart J. 2015 Feb 14;36(7):434-9.

ReferenceCitation: Packer M, McMurray JJ, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile M, Andersen K, Arango JL, Arnold JM, Bělohlávek J, Böhm M, Boytsov S, Burgess LJ, Cabrera W, Calvo C, Chen CH, Dukat A, Duarte YC, Erglis A, Fu M, Gomez E, Gonzàlez-Medina A, Hagège AA, Huang J, Katova T, Kiatchoosakun S, Kim KS, Kozan Ö, Llamas EB, Martinez F, Merkely B, Mendoza I, Mosterd A, Negrusz-Kawecka M, Peuhkurinen K, Ramires FJ, Refsgaard J, Rosenthal A, Senni M, Sibulo AS Jr, Silva-Cardoso J, Squire IB, Starling RC, Teerlink JR, Vanhaecke J, Vinereanu D, Wong RC; PARADIGM-HF Investigators and Coordinators. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015 Jan 6;131(1):54-61. doi: 10.1161/CIRCULATIONAHA.114.013748. Epub 2014 Nov 17.

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

ReferenceCitation: McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau J, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2013 Sep;15(9):1062-73. doi: 10.1093/eurjhf/hft052. Epub 2013 Apr 5.

location_country:
Spain
Italy
United Kingdom
Lithuania
Venezuela
United States
Peru
Belgium
Iceland
Philippines
Romania
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Argentina
India
Israel
Panama
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Dominican Republic
Latvia
Estonia
Ecuador
Czech Republic
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

summary: The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).


title: A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study

ReferenceCitation: Zhu AX, Chen D, He W, Kanai M, Voi M, Chen LT, Daniele B, Furuse J, Kang YK, Poon RT, Vogel A, Chiang DY. Integrative biomarker analyses indicate etiological variations in hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):296-304. doi: 10.1016/j.jhep.2016.04.015. Epub 2016 Apr 27.

ReferenceCitation: Zhu AX, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, Poon RT, Blanc JF, Vogel A, Chen CL, Dorval E, Peck-Radosavljevic M, Santoro A, Daniele B, Furuse J, Jappe A, Perraud K, Anak O, Sellami DB, Chen LT. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA. 2014 Jul 2;312(1):57-67. doi: 10.1001/jama.2014.7189.

location_country:
Taiwan
Hong Kong
Spain
Greece
Austria
Australia
Italy
Canada
Thailand
Hungary
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)

location_facility: Northwest Cancer Specialists Rose Quarter Cancer Center

location_facility: Methodist Charlton Cancer Center Methodist

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: California Pacific Medical Center California Pacific Med

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU

location_facility: Massachusetts General Hospital Dept. of Mass General Hospital

location_facility: Compassionate Cancer Care Medical Group CCCMG

location_facility: University of California San Diego - Moores Cancer Center SC - 3

location_facility: Midwest Cancer Care Physicians Research Medical Center

location_facility: VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS

location_facility: Queen's Medical Center Queens Cancer Center

location_facility: University of Rochester Medical Center Rochester

summary: The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.


title: Icatibant Outcome Survey (IOS) Registry

summary: The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

ReferenceCitation: Maurer M, Aberer W, Caballero T, Bouillet L, Grumach AS, Botha J, Andresen I, Longhurst HJ; IOS Study Group. The Icatibant Outcome Survey: 10 years of experience with icatibant for patients with hereditary angioedema. Clin Exp Allergy. 2022 Sep;52(9):1048-1058. doi: 10.1111/cea.14206. Epub 2022 Aug 7. Review.

ReferenceCitation: Guilarte M, Sala-Cunill A, Baeza ML, Cabañas R, Hernández MD, Ibañez E, de Larramendi CH, Lleonart R, Lobera T, Marqués L, de San Pedro BS, Botha J, Andresen I, Caballero T; IOS Study Group. Hereditary angioedema due to C1 inhibitor deficiency: real-world experience from the Icatibant Outcome Survey in Spain. Allergy Asthma Clin Immunol. 2021 Dec 29;17(1):137. doi: 10.1186/s13223-021-00641-3.

ReferenceCitation: Longhurst HJ, Dempster J, Lorenzo L, Buckland M, Grigoriadou S, Symons C, Bethune C, Fabien V, Bangs C, Garcez T. Real-world outcomes in hereditary angioedema: first experience from the Icatibant Outcome Survey in the United Kingdom. Allergy Asthma Clin Immunol. 2018 Aug 6;14:28. doi: 10.1186/s13223-018-0253-x. eCollection 2018.

ReferenceCitation: Caballero T, Zanichelli A, Aberer W, Maurer M, Longhurst HJ, Bouillet L, Andresen I; IOS Study Group. Effectiveness of icatibant for treatment of hereditary angioedema attacks is not affected by body weight: findings from the Icatibant Outcome Survey, a cohort observational study. Clin Transl Allergy. 2018 Mar 23;8:11. doi: 10.1186/s13601-018-0195-x. eCollection 2018.

ReferenceCitation: Aberer W, Maurer M, Bouillet L, Zanichelli A, Caballero T, Longhurst HJ, Perrin A, Andresen I; IOS Study Group. Breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis are responsive to icatibant: findings from the Icatibant Outcome Survey. Allergy Asthma Clin Immunol. 2017 Jul 5;13:31. doi: 10.1186/s13223-017-0203-z. eCollection 2017.

ReferenceCitation: Zanichelli A, Longhurst HJ, Maurer M, Bouillet L, Aberer W, Fabien V, Andresen I, Caballero T; IOS Study Group. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting. Ann Allergy Asthma Immunol. 2016 Oct;117(4):394-398. doi: 10.1016/j.anai.2016.08.014.

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Maurer M, Fabien V, Zanichelli A; IOS Study Group. The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks. Eur J Emerg Med. 2016 Jun;23(3):224-7. doi: 10.1097/MEJ.0000000000000292.

ReferenceCitation: Longhurst HJ, Aberer W, Bouillet L, Caballero T, Fabien V, Zanichelli A, Maurer M; IOS Investigators. Analysis of characteristics associated with reinjection of icatibant: Results from the icatibant outcome survey. Allergy Asthma Proc. 2015 Sep-Oct;36(5):399-406. doi: 10.2500/aap.2015.36.3892. Erratum in: Allergy Asthma Proc. 2015 Nov-Dec;36(6):511.

ReferenceCitation: Hernández Fernandez de Rojas D, Ibañez E, Longhurst H, Maurer M, Fabien V, Aberer W, Bouillet L, Zanichelli A, Caballero T; IOS Study Group. Treatment of HAE Attacks in the Icatibant Outcome Survey: An Analysis of Icatibant Self-Administration versus Administration by Health Care Professionals. Int Arch Allergy Immunol. 2015;167(1):21-8. doi: 10.1159/000430864. Epub 2015 Jun 25.

ReferenceCitation: Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.

lead_sponsor: Shire

location_country:
Denmark
Brazil
Spain
Greece
Austria
Australia
Ireland
Italy
United Kingdom
Sweden
France
Israel
Germany
Czechia

location_facility: Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: AO Ospedale Policlinico Consorziale Di Bari

location_facility: Klinikum der Johann-Wolfgang Goethe-Universitat

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden


title: Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics

summary: International Observational Registry on Schizophrenia

lead_sponsor: Janssen-Cilag International NV

location_country:
Spain
Greece
Russian Federation
Czech Republic
France
Turkey
South Africa
Germany


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

acronym: RENEW

summary:
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

ReferenceCitation: Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

lead_sponsor: Celgene

location_country:
Poland
Portugal
Spain
Italy
Russian Federation
United Kingdom
Puerto Rico
United States
France
Israel
Germany
Czechia

location_facility: Clinic of Oncology Faculty Hospital Motol

location_facility: Azienda Ospedaliera Universitaria "San Martino"

location_facility: Policlinico San Matteo - Dip. Di Ematologia

location_facility: Az. Osp. Ospedali Riuniti Papardo - Piemonte - S.C. Ematologia

location_facility: IRCCS Casa Sollievo della Sofferenza Div. Di Oncoematologia

location_facility: Städtisches Klinikum Karlsruhe - Hämatologie / Onkologie Karlsruhe

location_facility: CHD Les Oudairies, Service d'Oncologie Hématologie

location_facility: Fondazione San Raffaele del Monte Tabor I.R.C.C.S.

location_facility: CHU de Nancy Hôpital de Brabois, Service d'Hématologie et Médecine Interne

location_facility: State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1

location_facility: Hematology Dept, Azienda Ospedaliero Universitaria Careggi

location_facility: Centro de Cancer, Hospital Espanol Auxilio de Puerto Rico

location_facility: UKG Universitätsklinikum Göttingen Zentrum Innere Medizin Hämatologie / Onkologie

location_facility: Università del Piemonte Orientale "Amedeo Avogadro"

location_facility: Davidoff Cancer Center The Institute of Hematology

location_facility: Instituto Português de Oncologia (IPO) do Porto

location_facility: Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika

location_facility: Az. Osp. Bianchi Melacrino Morelli, Div. Di Ematologia

location_facility: Hospital Universitario Vall d´Hebrón Hematology Department

location_facility: Clinica Ematologica - DIRM Azienda Ospedaliera Universitaria

location_facility: Instituto Português de Oncologia (IPO) de Lisboa

location_facility: CHU de Reims, Hôpital Robert Debré, Hématologie Clinique

location_facility: Klinikum der Universität München - Großhadern, Medizinische Klinik III

location_facility: Ospedale Regionale di Bolzano - Divisione di Ematologia

location_facility: Barts & The London NHS Trust Medical Oncology

location_facility: Hôpital Henri Mondor Unité Hémopathies Lymphoides

location_facility: Universitätsklinikum Essen Zentrum für Innere Medizin

location_facility: A,O Ospedale Niguarda Ca Granda Dept Hematology

location_facility: Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-biological agency

location_facility: CHRU - Hôpital du Haut Lévêque, maladies du sang, Centre François Magendie

location_facility: Clinica Universitaria de Navarra, Hematology

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Az. Osp. SS.Antonio e Biagio SC Ematologia

location_facility: Hôpital Pontchaillou Hématologie Clinique

location_facility: Universitätsklinikum Freiburg - Medizinische Klinik - Abteilung Innere Medizin I: Hämatologie und Onkologie

location_facility: Soroka Medical Center The Institute of Hematology

location_facility: Istituto Nazionale Tumori Fondazione "G. Pascale" - Oncoematologia

location_facility: Dolnoslaskie Centrum Transplantacji Komórkowych

location_facility: State Educational Institution of High Professional Education

location_facility: Asklepios Klinik St. Georg - Abteilung für Hämatologie und Stammzelltransplantation

location_facility: Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie

location_facility: Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie

location_facility: Salisbury NHS Foundation Trust, Haematology

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Weill Cornell Medical College/New York Presbyterian Hospital

location_facility: Ospedale Cardinale G. Panico - Ematologia e Immunoematologia

location_facility: Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette)

location_facility: Republican Clinical Oncological Dispensary

location_facility: CHU Montpellier - Hôpital Saint Eloi Hématologie et Oncologie Médicale

location_facility: Sharp Healthcare Oncology Associates of San Diego

location_facility: CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie, Service d'Oncologie Hématologie et Thérapie Cellulaire

location_facility: Sverdlovsk Regional Clinical Hospital - Volgogradskaya

location_facility: Università Cattolica del Sacro Cuore Policlinico A. Gemelli

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov Rosmedtechnologies


title: An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke

summary: The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

ReferenceCitation: Fheodoroff K, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Turner-Stokes L. Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study. Toxins (Basel). 2015 Apr 8;7(4):1192-205. doi: 10.3390/toxins7041192.

ReferenceCitation: Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P. Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open. 2013 Jun 20;3(6). pii: e002771. doi: 10.1136/bmjopen-2013-002771.

ReferenceCitation: Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open. 2013 Mar 18;3(3). pii: e002230. doi: 10.1136/bmjopen-2012-002230.

lead_sponsor: Ipsen

location_country:
Spain
Italy
United Kingdom
Belgium
Philippines
Czechia
Portugal
Austria
Australia
Russian Federation
Mexico
Sweden
Malaysia
Singapore
China
Germany
Denmark
Taiwan
Finland
Thailand
Korea, Republic of
France

location_facility: Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)

location_facility: Läkarhuset Odenplan, Neuro Unit (site 752003)

location_facility: Hopital Albert Chenevier/Neurologie, (site 250010)

location_facility: Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)

location_facility: Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)

location_facility: Ospedale Valduce, Costa Masnaga (site 380001)

location_facility: Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)

location_facility: Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)

location_facility: Praxis für Neurologie Mittelstr. 4 (site 276008)

location_facility: Azienda Ospedaliera Universitaria (site 380012)

location_facility: Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)

location_facility: Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)

location_facility: CHRU Lille/Rééducation Neurologique (site 250018)

location_facility: Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)

location_facility: Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)

location_facility: Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)

location_facility: Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)

location_facility: Centro de Medicina de Reabilitação de Alcoitão (site 620001)

location_facility: Metropolitan Medical Center (site 608001)

location_facility: Dept. for Rehabilitation Asan Medical Center (site 410005)

location_facility: Kinik für Neurologie Paracelsusring 6a (site 276003)

location_facility: State Institution "Interregional clinical diagnostic centre" (site 643002)

location_facility: Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)

location_facility: Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)

location_facility: Mälarsjukhuset, Dept. Of Neurology (site 752001)

location_facility: State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)

location_facility: Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)

location_facility: CHU Hôpital SUD/Institut de Rééducation (site 250007)

location_facility: State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)

location_facility: Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)

location_facility: Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)

location_facility: Hôpital Rangueil/Médecine Physique réadaptation (site 250015)

location_facility: Royal Prince Alfred Hospital (site 036005)

location_facility: Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)

location_facility: Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)

location_facility: Hospital La Paz / Servicio de Rehabilitación (site 724006)

location_facility: Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)

location_facility: NÖ LKH Grimmenstein-Hochegg (site 040002)

location_facility: Perpetual Succour Hospital (site 608002)

location_facility: Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)

location_facility: Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)

location_facility: CHU Lapeyronie /Rééducation fonctionnelle (site 250014)

location_facility: Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)

location_facility: Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)

location_facility: Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)

location_facility: Herlev Hospital, Herlev Ringvej (Site 208004)

location_facility: Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)

location_facility: Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)

location_facility: CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)

location_facility: Hospital Pardubice, Neurology dept. (site 203001)

location_facility: Neurologiska Polikliniken, Tampere University Hospital (site 246001)

location_facility: AZ St. Jan, Ruddershove 10, (site 056002)

location_facility: Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)

location_facility: Dewsbury District Hospital (site 826004)

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)

location_facility: Hospital Distrital de Faro (site 620004)

location_facility: Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)

location_facility: Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)

location_facility: Northshore Private Hospital (site 036003)

location_facility: Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)

location_facility: UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)

location_facility: Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)

location_facility: Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)

location_facility: Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)

location_facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)

location_facility: Paracelsus Klinik Werdauer Str. 68 (site 276002)

location_facility: Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)

location_facility: Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)

location_facility: King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)

location_facility: China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)

location_facility: Municipal health care institution "City clinical hospital #3" (site 643006)

location_facility: Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)

location_facility: Dept. Of Neurology, Nyköping Hospital (site 752002)

location_facility: West Midlands/Rehabilitation Centre (826005)

location_facility: Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)

location_facility: Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)

location_facility: Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)

location_facility: Ryde Rehabilitation Center (site 036002)

location_facility: Hospital Universitario La Fe (Site 724003)

location_facility: Praxis für Neurologie, Dalberger Str. 6 (site 276007)

location_facility: Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)

location_facility: NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1