acronym: RAINBOW

title: RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

ReferenceCitation: Fleck BW, Reynolds JD, Zhu Q, Lepore D, Marlow N, Stahl A, Li J, Weisberger A, Fielder AR; RAINBOW Investigator Group. Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial. Ophthalmol Retina. 2022 Jul;6(7):628-637. doi: 10.1016/j.oret.2022.02.006. Epub 2022 Feb 22.

ReferenceCitation: Stahl A, Lepore D, Fielder A, Fleck B, Reynolds JD, Chiang MF, Li J, Liew M, Maier R, Zhu Q, Marlow N. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019 Oct 26;394(10208):1551-1559. doi: 10.1016/S0140-6736(19)31344-3. Epub 2019 Sep 12.

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

location_country:
Croatia
Saudi Arabia
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Russian Federation
India
Turkey
Mexico
Malaysia
Slovakia
Egypt
Hungary
Germany
Denmark
Taiwan
Greece
Estonia
France

summary: The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).


title: Open-label, Multicenter,PhaseI Trial in Order To Determine the Safety and Pharmacokinetics of BAY43-9006 in Combination With Docetaxel as First-line Treatment in Metastatic Hormone Refractory Prostate Cancer Patients

summary:
The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to taxotere for first-line treatment of patient with prostatic cancer.

BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is orally available and has a favorable safety profile in patients with advanced solid tumors. This, together with the antitumor activity observed after treatment with BAY 43-9006 (SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer. The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a continuous dosing schedule.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: France Belgium

location_facility:
Clinique Universiataire de Mont Godinne
Hôpital Européen Georges Pompidou
Notre Dame et Reine Fabiola
Cliniques Universitaires St Luc
St Pierre
Sainte Elisabeth

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.

summary: The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

ReferenceType: background

ReferenceCitation: Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
France

lead_sponsor_type: industriel


title: Immune Response to the Recombinant Zoster Vaccine in People Living With HIV Over 50 Years of Age Compared to Non-HIV Age- and Gender-matched Controls - The Shingr'HIV Phase IV Multicenter Study

acronym: Shingr'HIV

summary: The purpose of this study is to evaluate the efficacy and safety of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in older people (> 50 years) living with HIV (PLWH) compared to age-matched healthy adults over a 1-year period.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Calmy Alexandra

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudoise (CHUV)

intervention_type: Biological

status_simplified: Ongoing


type: EudraCT Number

type: Registry Identifier

title: Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing

acronym: ADAPT ALEC

summary: The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng/Ml (arm A) with standard of care (arm B).

study_start_date_type: Actual

status: Recruiting

design_allocation: Randomized

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie the results will only be shared upon reasonable request from the Principal Investigator at the UMCG, who will discuss the request with the ADAPT ALEC study team.

lead_sponsor: University Medical Center Groningen

location_country: Netherlands France

location_facility:
The Netherlands Cancer Institute
Gustave Roussy
Erasmus Medical Center
University Medical Center Groningen
Radboud University Medical Center
Leiden University Medical Center
Amsterdam University Medical Center
Maastricht University Medical Center +


acronym: CIMPACT

title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

lead_sponsor: UCB Biopharma S.P.R.L.

source: euctr

ReferenceType: result

ReferenceCitation: Lebwohl M, Blauvelt A, Paul C, Sofen H, Węgłowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.

ReferenceCitation: Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17.

ReferenceType: derived

ReferenceCitation: Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

location_country:
Poland
United Kingdom
Netherlands
Hungary
United States
France
Germany
Bulgaria
Czechia

summary: The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.


title: Phase II Clinical Trial to Evaluate the Efficacy and Safety of First Line Atezolizumab in Combination With Paclitaxel and Bevacizumab (Avastin®) in Patients With Advanced or Metastatic Triple-negative Breast Cancer

acronym: ATRACTIB

summary: This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate to evaluate the efficacy and safety of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with advanced or metastatic triple-negative breast cancer (mTNBC)

ReferenceCitation: Agostinetto E, Eiger D, Punie K, de Azambuja E. Emerging Therapeutics for Patients with Triple-Negative Breast Cancer. Curr Oncol Rep. 2021 Mar 24;23(5):57. doi: 10.1007/s11912-021-01038-6. Review.

lead_sponsor: MedSIR

location_country:
United Kingdom
Spain
Italy
France
Germany

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Hospital de Sant Joan Despí - Moises Broggi


title: Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

acronym: ELISIR

summary: The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

study_type: Observational

time_perspective: Other

ReferenceCitation: Gulletta S, Gasperetti A, Schiavone M, Vogler J, Fastenrath F, Breitenstein A, Laredo M, Palmisano P, Mitacchione G, Compagnucci P, Kaiser L, Hakmi S, Angeletti A, De Bonis S, Picarelli F, Arosio R, Casella M, Steffel J, Fierro N, Guarracini F, Santini L, Pignalberi C, Piro A, Lavalle C, Pisanò E, Viecca M, Curnis A, Badenco N, Ricciardi D, Dello Russo A, Tondo C, Kuschyk J, Della Bella P, Biffi M, Forleo GB, Tilz R. Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry. Heart Rhythm. 2022 Jul;19(7):1109-1115. doi: 10.1016/j.hrthm.2022.02.029. Epub 2022 Mar 5.

ReferenceCitation: Forleo GB, Gasperetti A, Breitenstein A, Laredo M, Schiavone M, Ziacchi M, Vogler J, Ricciardi D, Palmisano P, Piro A, Compagnucci P, Waintraub X, Mitacchione G, Carrassa G, Russo G, De Bonis S, Angeletti A, Bisignani A, Picarelli F, Casella M, Bressi E, Rovaris G, Calò L, Santini L, Pignalberi C, Lavalle C, Viecca M, Pisanò E, Olivotto I, Curnis A, Dello Russo A, Tondo C, Love CJ, Di Biase L, Steffel J, Tilz R, Badenco N, Biffi M. Subcutaneous implantable cardioverter-defibrillator and defibrillation testing: A propensity-matched pilot study. Heart Rhythm. 2021 Dec;18(12):2072-2079. doi: 10.1016/j.hrthm.2021.06.1201. Epub 2021 Jun 30.

ReferenceCitation: Ricciardi D, Ziacchi M, Gasperetti A, Schiavone M, Picarelli F, Diemberger I, Bontempi L, Di Belardino N, Bisignani G, De Bonis S, Mitacchione G, Calabrese V, Lavalle C, Piro A, Pignalberi C, Santini L, Grigioni F, Tondo C, Biffi M, Forleo GB. Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry. J Cardiovasc Electrophysiol. 2021 Feb;32(2):468-476. doi: 10.1111/jce.14833. Epub 2020 Dec 18.

ipd_sharing: Undecided

lead_sponsor: Luigi Sacco University Hospital

location_country: Germany France Switzerland Italy

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Ospedale Luigi Sacco - Polo Universitario

location_facility: Policlinico Universitario Campus Bio-Medico

intervention_type: Device


title: International Validation of Two Non-motor Scales in Parkinson's Disease: the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in Parkinson's Disease (SPARK) Scale

summary: The goal of this project is to develop the international validation of two new rating scales, the Neuropsychiatric Fluctuations Scale (NFS) and the Shame in PARKinson's disease (SPARK) Scale, in order to improve the understanding of the extent and severity of non-motor symptoms in Parkinson's disease (PD).

time_perspective: Prospective

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Spain
Greece
United Kingdom
Switzerland
France
Romania
Germany

location_facility: Centre hospitalier régional universitaire de Besançon

location_facility: Insel Gruppe AG University Hospital Bern


title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS

summary: To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

ReferenceCitation: Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471.

ReferenceCitation: Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6.

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:
Japan
Netherlands
United States
France

location_facility: UConn Health, Neag Comprehensive Cancer Center

location_facility: Santa Monica UCLA Hematology & Oncology Clinic

location_facility: Mass General/North Shore Center for Outpatient Care

location_facility: Slotervaart Hospital/Antoni van Leeuwenhoek

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Medical Imaging Center of Southern California, Inc.

location_facility: The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Massachusetts General/Chelsea HealthCare Center


title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

acronym: COBALT

summary: Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

status: Terminated

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906.

ReferenceCitation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Poland
Hong Kong
Austria
Australia
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Estonia
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore

location_facility: University of California Davis, Davis Medical Center

location_facility: Gastrocentro. Unidad Estadual de CAmpinas UNICAMP

location_facility: Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo

location_facility: Vilnius University Hospital Santaros klinikos

location_facility: Ege University School of Medicine Gastroenterology Dept.

location_facility: Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Aarhus University Hospital Department of Hepatology and Gastroenterology

location_facility: Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S

location_facility: Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO

location_facility: Turku University Central Hospital, Gastroenterology Outpatient Clinic

location_facility: East Tallinn Central Hospital Gastroenterology Center

location_facility: University Of Debrecen, Department Of Medicine, Division Of Gastroenterology

location_facility: Cambrigde University Hospitals NHS Foundation Trust

location_facility: Department of Gastroenterology and Hepatology, Royal Adelaide Hospital

location_facility: Universität Leipzig KöR, Medizinische Fakultät

location_facility: Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: Hospital of the University of Pennsylvania

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main

location_facility: Békés Megyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz

location_facility: Inselspital, University Of Bern, UVCM, DMLL

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

location_facility: Instituto Hospital de Base do Distrito Federal-IHBDF

location_facility: University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: Ankara University School of Medicine Gastroenterology Dept.

location_facility: Amsterdam University Medical Centre (AMC)

location_facility: Hadassah Hebrew University Medical Center

location_facility: USZ, Klinik für Gastroenterologie und Hepatologie

location_facility: University of Louisville, Medical Dental Complex

location_facility: Azienda Ospedaliero - Universita di Padova

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum

location_facility: Hospital of Lithuanian University of Health Sciences, Kauno klinikos

location_facility: Università Politecnica delle Marche - Azienda Ospedaliero

location_facility: AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych

location_facility: UT Health The University of Texas Health Science Center at Houston

location_facility: Azienda Ospedaliero Universitaria Careggi Universita di Firenze

location_facility: Fiona Stanley Hospital, Gastroenterology Department

location_facility: Southern Therapy and Advanced Research (STAR)

location_facility: University of Colorado Denver and Hospital

location_facility: Centro De Investigaciones Clínicas Viña Del Mar

location_facility: Department of Gastroenterology & Hepatology, Nepean Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)

location_facility: Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej

location_facility: Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw

location_facility: Medicinsk klinik for mave, tarm-og leversygdomme

location_facility: American Research Corporation at Texas Liver Institute

location_facility: Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato

location_facility: Hospital Privado Universitario de Cordoba S.A.

location_facility: AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: University Health Network, Toronto General Hospital

status_simplified: Unknown


title: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

acronym: EXCeL

summary:
EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry.

This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

ipd_sharing_description:
Data collected on each subject will be recorded on an online electronic CRF. A paper version of the CRFs may be printed at the sites to use as a working copy. Instructions for proper completion of the electronic CRF and how to use it online will be provided to the clinical site. The investigator or an authorized member of the investigational team must sign all completed CRFs, by using a unique signature code. This code will be provided to the user at the start of the study.

All records and other information about subjects participating in this registry will be treated as confidential. The sponsor, Department of Vascular Surgery, Catharina Hospital, Eindhoven, will collect data and monitors study records.Study data may be made available to third parties, e.g., in the case of an audit performed by regulatory authorities, provided the data are treated confidentially and that the subject's privacy is guaranteed.

lead_sponsor: Marc van Sambeek

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility:
APHP Hopital Européen
Catharina Hospital
Rijnstate Hospital
Niels Stensen Kliniken
Sant'Orsola Hospital
Blefast health and Social Care Trust
San Martino Hospital
North Bristol NHS Trust
San Carlos Hospital
Klinikum Darmstadt
Complexo Hospitalario de Orense

intervention_type: Procedure


title: Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

summary: Lead survivability will be summarized.

lead_sponsor: Medtronic

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

location_facility:
St Luke's University Health Network
Hattiesburg Clinic


title: A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI

acronym: QUORUM

summary:
This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI.

Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.

ReferenceCitation: Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

lead_sponsor: Quantum Genomics SA

location_country:
Poland
Spain
United Kingdom
Hungary
France
Germany
Slovakia

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie

location_facility: NUSCH Bratislava Dpt. of Acute Cardiology


title: PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

summary: This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

lead_sponsor: Provectus Biopharmaceuticals, Inc.

location_country:
Italy
United States
France
Mexico
Germany

location_facility: Klinik für Dermatologie Universitätsklinikum Essen Studienzentrum

location_facility: Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Schleswig-Holstein Hautkrebszentrum

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Centro de Estudios y Prevención del Cancer A.C.

location_facility: Azienda Sanitaria Azienda Ospedaliera Universitaria Senese

location_facility: St Luke's University Hospital and Health Network

location_facility: Washington University School of Medicine - Dermatology

location_facility: Klinik für Dermatologie, Venerologie und Allergologie Charite Universitätsmedizin Berlin

location_facility: Moffitt Cancer Center and Research Institute

location_facility: IRCCS Instituto Nazionale Tumori "Fondazione Giovanni Pascale"

location_facility: Istituto Dermopatico dell'Immacolata (IDI IRCCS)

location_facility: Hautklinik Klinikum der Johannes Gutenberg Universität Hautkrebszentrum

location_facility: Unité Cancéro-Dermatologie, Hôtel-Dieu CHU Nantes

location_facility: Sharp Memorial Hospital - Clinical Oncology Research


title: A Phase Ib/II Multi-center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients With BRAFV600-mutant KRAS Wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations

summary:
The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.

The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

lead_sponsor: Array BioPharma

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

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC) MSKCC (3)

location_facility: Medical University of South Carolina Oncology Dept

location_facility: University of Texas/MD Anderson Cancer Center Onc. Dept,


title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study of AG-221 in Subjects With Advanced Solid Tumors, Including Glioma, and With Angioimmunoblastic T-cell Lymphoma, That Harbor an IDH2 Mutation

summary: The purpose of this study is to evaluate the safety, pharmacokinetics, and clinical activity of enasidenib in adults with advanced solid tumors, including glioma, or with angioimmunoblastic T-cell lymphoma (AITL), with an isocitrate dehydrogenase-2 (IDH2) mutation.

lead_sponsor: Celgene


title: ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

summary: The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

status: Active, not recruiting

lead_sponsor: ImThera Medical, Inc.

location_country:
Portugal
United States
France
Israel
Belgium
Germany

location_facility: Ear, Nose, and Throat Associates of South Florida


status: Withdrawn

title: Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE

lead_sponsor: Gilead Sciences

location_country: Poland France Spain Italy

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

location_facility: Centre Hospitalier Régional Universitaire de Lille

summary: The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)


acronym: PUPs B-LONG

title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

lead_sponsor: Bioverativ, a Sanofi company

ReferenceCitation: Nolan B, Klukowska A, Shapiro A, Rauch A, Recht M, Ragni M, Curtin J, Gunawardena S, Mukhopadhyay S, Jayawardene D, Winding B, Fischer K, Liesner R. Final results of the PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B. Blood Adv. 2021 Jul 13;5(13):2732-2739. doi: 10.1182/bloodadvances.2020004085.

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

location_country:
Denmark
Poland
United Kingdom
Ireland
Italy
Australia
New Zealand
Sweden
United States
France
Netherlands

location_facility:
Hopital Cardiologique - CHU Lille
Research Site

summary: The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.


title: A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

lead_sponsor: Novartis Pharmaceuticals

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

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

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

summary: The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.


title: REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

acronym: REPRISE III

summary: The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

ReferenceCitation: Rizik DG, Rajagopal V, Makkar RR, Bajwa T, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Iyer VS, Buchbinder M, Gotberg M, Bjursten H, Allocco DJ, Reardon MJ. Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238792. doi: 10.1001/jamanetworkopen.2022.38792.

ReferenceCitation: Goel K, O'Leary JM, Barker CM, Levack M, Rajagopal V, Makkar RR, Bajwa T, Kleiman N, Linke A, Kereiakes DJ, Waksman R, Allocco DJ, Rizik DG, Reardon MJ, Lindman BR. Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep;9(17):e017075. doi: 10.1161/JAHA.120.017075. Epub 2020 Aug 28.

ReferenceCitation: Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Schindler J, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. J Am Heart Assoc. 2019 Nov 5;8(21):e012594. doi: 10.1161/JAHA.119.012594. Epub 2019 Oct 23.

ReferenceCitation: Reardon MJ, Feldman TE, Meduri CU, Makkar RR, O'Hair D, Linke A, Kereiakes DJ, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchétché D, Rovin JD, Lhermusier T, Carrié D, Hodson RW, Allocco DJ, Meredith IT; Reprise III Investigators. Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.

ReferenceCitation: Asch FM, Vannan MA, Singh S, Khandheria B, Little SH, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ, Weissman NJ. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. 2018 Jun 12;137(24):2557-2567. doi: 10.1161/CIRCULATIONAHA.118.034129. Epub 2018 Mar 12.

ReferenceCitation: Feldman TE, Reardon MJ, Rajagopal V, Makkar RR, Bajwa TK, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchétché D, Rovin JD, Buchbinder M, Meredith IT, Götberg M, Bjursten H, Meduri C, Salinger MH, Allocco DJ, Dawkins KD. Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial. JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.

lead_sponsor: Boston Scientific Corporation

location_country:
Australia
Netherlands
Canada
United States
France
Germany

location_facility: Wake Forest University School of Medicine

location_facility: Hospital of the University of Pennsylvania

location_facility: Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital

location_facility: St. John's Hospital - Prairie Cardiovascular Consultants

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Washington University School of Medicine - Barnes Jewish Medical Center

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: University of California at Davis Medical Center

location_facility: McGill University Health Centre, Royal Victoria Hospital

location_facility: Ohio Health Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Erasmus MC - University Medical Center Rotterdam

location_facility: NC Heart and Vascular Research - Rex Hospital

location_facility: Abbott Northwestern Hospital - Minneapolis Heart Institute

location_facility: Veteran's Administration Palo Alto Medical Center


title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

lead_sponsor: Alios Biopharma Inc.

location_country:
Taiwan
Romania
United Kingdom
Australia
New Zealand
Canada
Thailand
United States
Chile
France
Panama
Colombia
Japan
South Africa

location_facility: Siriraj Hospital, Mahidol University Department of Pediatrics

location_facility: Children's Hospital/University of Tennessee

location_facility: Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"

location_facility: Hospital Materno Infantil Jose Dominog de Obaldila

location_facility: Khon Kaen University Department of Pediatrics

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Chulalongkorn University Department of Pediatrics

location_facility: Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Phramongkutklao Hospital Department of Pediatrics

location_facility: The University of North Carolina at Chapel Hill

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: The Children's Hospital Research Institute of Manitoba

location_facility: National Hospital Organization Saitama National Hospital

location_facility: The University of California at San Diego

location_facility: Canadian Centre for Vaccinology IWK Health Centre

location_facility: NHO Shikoku Medical Center for Children and Adults

location_facility: Institute for Mother and Child Care "Alfred Rusescu"

location_facility: National Center for Child Health and Development

location_facility: Fundacion Cardio Infantil Instituto de Cardiologia

location_facility: Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach

location_facility: The Research Institute at Nationwide Children's Hospital

location_facility: Texas Children's Hospital/Baylor College of Medicine

summary: This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

summary: This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.

ReferenceCitation: Narita I, Ohashi T, Sakai N, Hamazaki T, Skuban N, Castelli JP, Lagast H, Barth JA. Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study. Clin Exp Nephrol. 2020 Feb;24(2):157-166. doi: 10.1007/s10157-019-01810-w. Epub 2019 Dec 30.

lead_sponsor: Amicus Therapeutics

location_country:
Denmark
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Canada
United States
France
Turkey
Belgium
Japan
Egypt


title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)

summary: This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.

ReferenceCitation: Brannagan TH, Coelho T, Wang AK, Polydefkis MJ, Dyck PJ, Berk JL, Drachman B, Gorevic P, Whelan C, Conceição I, Plante-Bordeneuve V, Merlini G, Obici L, Plana JMC, Gamez J, Kristen AV, Mazzeo A, Gentile L, Narayana A, Olugemo K, Aquino P, Benson MD, Gertz M; NEURO-T. T. R. Open-Label Extension Investigators. Long-term efficacy and safety of inotersen for hereditary transthyretin amyloidosis: NEURO-TTR open-label extension 3-year update. J Neurol. 2022 Dec;269(12):6416-6427. doi: 10.1007/s00415-022-11276-8. Epub 2022 Jul 31.

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Zhu JJ, Greatsinger A, Bozas A, Vera-Llonch M, Signorovitch J. Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial. Muscle Nerve. 2022 Oct;66(4):438-446. doi: 10.1002/mus.27675. Epub 2022 Aug 4.

ReferenceCitation: Yarlas A, Lovley A, McCausland K, Brown D, Vera-Llonch M, Conceição I, Karam C, Khella S, Obici L, Waddington-Cruz M. Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR. Neurol Ther. 2021 Dec;10(2):865-886. doi: 10.1007/s40120-021-00268-x. Epub 2021 Aug 5.

ReferenceCitation: Brannagan TH, Wang AK, Coelho T, Waddington Cruz M, Polydefkis MJ, Dyck PJ, Plante-Bordeneuve V, Berk JL, Barroso F, Merlini G, Conceição I, Hughes SG, Kwoh J, Jung SW, Guthrie S, Pollock M, Benson MD, Gertz M; NEURO-TTR open-label extension investigators. Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial. Eur J Neurol. 2020 Aug;27(8):1374-1381. doi: 10.1111/ene.14285. Epub 2020 May 29.

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
Argentina
United States
France
Germany

location_facility: CHP-HGSA, Unidade Clinica de Paramiloidose

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico San Matteo

location_facility: Boston University School of Medicine - Amyloid Treatment & Research Program

location_facility: Universita Degli Studi Di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino"

location_facility: UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin

location_facility: CHU Bicetre Aphp French Referral Center for FAP/Cornamyl Network

location_facility: University College London - National Amyloidosis Centre

location_facility: Johns Hopkins University Bayview Medical Center

location_facility: Columbia University Medical Center - The Neurological Institute

location_facility: CHU Henri Mondor - Department of Neurology

location_facility: Federal University of Rio de Janeiro - University Hospital


title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

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

lead_sponsor: Amgen

location_country:
Poland
Spain
Greece
Austria
Italy
Russian Federation
Canada
United Kingdom
Switzerland
Hungary
Korea, Republic of
United States
France
South Africa
Germany

location_facility: University of North Carolina Chapel Hill

location_facility: The West Clinic PC dba West Cancer Center

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Greenville Health System Institute for Translational Oncology Research

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University of Texas MD Anderson Cancer Center

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Wake Forest Baptist Health Medical Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Providence Oncology and Hematology Care Eastside

location_facility: University of Arkansas for Medical Sciences

location_facility: Yonsei University Health System Severance Hospital

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Allina Health System dba Virginia Piper Cancer Institute

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu

intervention_type: Other


acronym: HIBISCUS I

title: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Rubin DT, Dotan I, DuVall A, Bouhnik Y, Radford-Smith G, Higgins PDR, Mishkin DS, Arrisi P, Scalori A, Oh YS, Tole S, Chai A, Chamberlain-James K, Lacey S, McBride J, Panés J; HIBISCUS Study Group. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):17-27. doi: 10.1016/S2468-1253(21)00338-1. Epub 2021 Nov 17. Erratum in: Lancet Gastroenterol Hepatol. 2022 Apr;7(4):e8.

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

location_country:
Poland
Brazil
Hong Kong
Serbia
Russian Federation
Australia
Estonia
Argentina
Ukraine
United States
France
Mexico
Bulgaria
Slovakia

location_facility: FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

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

location_facility: SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

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

location_facility: General Hospital "Djordje Joanovic"; Gastroenterology

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

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

location_facility: Medical and Sanitary Division of Severstal

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

summary: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.


title: Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

summary: The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

lead_sponsor: Coloplast A/S

location_country:
Australia
Canada
United States
France
Belgium
Netherlands

location_facility: Wellspan Urogynecology and Pelvic Reconstructive Surgery

location_facility: Central Texas Urogynecology and Continence Center

location_facility: Women's Pelvic Health and Continence Center

location_facility: Female Pelvic Medicine & Urogynecology Institute of MI

location_facility: Centre for Advanced Reproductive Endosurgery

location_facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery

location_facility: Center for Urogynecology and Pelvic Surgery, Christiana Care Health System

location_facility: MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery

location_facility: Premier Medical Group of Hudson Valley, PC


title: A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

summary: The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

ReferenceCitation: Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.

location_country:
Taiwan
Spain
Colombia
Austria
Australia
Mexico
Argentina
Russian Federation
Switzerland
United Kingdom
Hungary
United States
Chile
France
Turkey
Belgium
Japan
Germany
Czechia


title: Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis

summary: This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.

primary_purpose: Diagnostic

lead_sponsor: Proactina S.A.

location_country: Hungary France

location_facility: Országos Klinikai Idegtudományi Intézet (OKITI)

location_facility: Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

summary: The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.

status: Unknown status

ReferenceCitation: Ljubenkov PA, Edwards L, Iaccarino L, La Joie R, Rojas JC, Koestler M, Harris B, Boeve BF, Borroni B, van Swieten JC, Grossman M, Pasquier F, Frisoni GB, Mummery CJ, Vandenberghe R, Le Ber I, Hannequin D, McGinnis SM, Auriacombe S, Onofrj M, Goodman IJ, Riordan HJ, Wisniewski G, Hesterman J, Marek K, Haynes BA, Patzke H, Koenig G, Hilt D, Moebius H, Boxer AL. Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients With Progranulin Gene Haploinsufficiency: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2125584. doi: 10.1001/jamanetworkopen.2021.25584.

lead_sponsor: FORUM Pharmaceuticals Inc

location_country:
United Kingdom
Italy
United States
France
Belgium
Netherlands

location_facility: Neurological Clinic, University of Brescia, AO Civil Hospital of Brescia

location_facility: Perelman School of Medicine, University of Pennsylvania

location_facility: Fondazione Universita Gabriele D'Annunzio di Chieti

location_facility: IRCCS - Centro S. Giovanni di Dio FateBeneFratelli

location_facility: The National Hospital for Neurology and Neuroscience


title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)

acronym: DAWN

summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.

ReferenceCitation: Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12:CD010995. doi: 10.1002/14651858.CD010995.pub3. Review.

ReferenceCitation: Liebeskind DS, Saber H, Xiang B, Jadhav AP, Jovin TG, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG; DAWN Investigators. Collateral Circulation in Thrombectomy for Stroke After 6 to 24 Hours in the DAWN Trial. Stroke. 2022 Mar;53(3):742-748. doi: 10.1161/STROKEAHA.121.034471. Epub 2021 Nov 3.

ReferenceCitation: Liebeskind DS, Saber H, Bhuva P, Xiang B, Yoo AJ, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG, Jovin TG. Serial ASPECTS in the DAWN Trial: Infarct Evolution and Clinical Impact. Stroke. 2021 Oct;52(10):3318-3324. doi: 10.1161/STROKEAHA.120.033477. Epub 2021 Jul 20.

ReferenceCitation: Tekle WG, Hassan AE, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila CA, Smith WS, Saver JL, Liebeskind DS, Shields R, Nogueira RG, Jovin TG; DAWN Trial Investigators. Impact of Periprocedural and Technical Factors and Patient Characteristics on Revascularization and Outcome in the DAWN Trial. Stroke. 2020 Jan;51(1):247-253. doi: 10.1161/STROKEAHA.119.026437. Epub 2019 Nov 20.

ReferenceCitation: Aghaebrahim A, Jadhav AP, Hanel R, Sauvageau E, Granja MF, Zhang Y, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Ribo M, Cognard C, Sila C, Yavagal D, Hassan AE, Smith WS, Saver J, Liebeskind DS, Nogueira RG, Jovin TG; DAWN Investigators. Outcome in Direct Versus Transfer Patients in the DAWN Controlled Trial. Stroke. 2019 Aug;50(8):2163-2167. doi: 10.1161/STROKEAHA.119.025710. Epub 2019 Jul 15.

ReferenceCitation: Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

lead_sponsor: Stryker Neurovascular

location_country:
Spain
Australia
Canada
United States
France

location_facility: Florida Hospital; Neuroscience Research Center

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Emory University at Grady Memorial Hospital

location_facility: JFK Neuroscience Institute at JFK Medical Center

location_facility: Toronto Western Hospital - University Health Network

location_facility: University Hospitals Case Medical Center


title: Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis or Peritoneal Dialysis

acronym: VERIFIE

summary:
An oral highly potent P binder Velphoro is a mixture of polynuclear iron(III) oxyhydroxide, sucrose, and starches. It was well tolerated in the clinical development program. The approved indication in the European Union (EU) is to control serums phosphorus (sP) levels in adult CKD (Chronic kidney disease) patients on HD (Haemodialysis) or PD (Peritoneal dialysis).

It is of major interest to observe the drug in daily use outside of controlled trial settings. The Marketing Authorisation Holder wishes to obtain further systematic data within a non-interventional study to investigate short and long-term safety.

Effectiveness and Treatment adherence during real-life use will be evaluated.

lead_sponsor: Vifor Fresenius Medical Care Renal Pharma

location_country:
Spain
Italy
Greece
Netherlands
United Kingdom
France
Germany

location_facility: Hospital Universitario Marqués de Valdecilla


title: A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

acronym: McCAVE

summary: This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.

location_country:
Spain
United Kingdom
Austria
Australia
United States
France
Belgium

location_facility: Va Greater Los Angeles Healthcare System

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

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

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: University of California San Diego Medical Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

acronym: CAPE

summary: This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

lead_sponsor: AbbVie

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Czechia
Portugal
Puerto Rico
Israel
Sweden
Bosnia and Herzegovina
Canada
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
France
Netherlands

location_facility: Children's Ctr Digestive, US /ID# 144625

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 139400

location_facility: Columbia Univ Medical Center /ID# 144440

location_facility: Universitatsklinikum Munster /ID# 148441

location_facility: Univ of Mississippi Med Ctr,US /ID# 137239

location_facility: Children's Hospital New Orleans /ID# 144477

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 143779

location_facility: A.O.U. Policlinico G. Martino /ID# 141683

location_facility: CT Childrens Medical Ctr, US /ID# 137265

location_facility: Schneider Children's Medical Center /ID# 152683

location_facility: Children's Hospital Wisconsin - Milwaukee Campus /ID# 137259

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 127697

location_facility: Hospital Universitario La Paz /ID# 161152

location_facility: Karolinska University Hospital Solna /ID# 129045

location_facility: Christliches Kinderhospital Osnabrueck /ID# 136629

location_facility: University Clinical Center Tuzla /ID# 130638

location_facility: Penn State Child Hosp.Hersh,PA /ID# 144476

location_facility: NHS Greater Glasgow and Clyde /ID# 127436

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157872

location_facility: Duplicate_Universita di Napoli Federico II /ID# 144280

location_facility: Ctr. Gastroenterologia Ped Oes /ID# 140875

location_facility: Children's Clinic Of Tartu Uni /ID# 146017

location_facility: Hospital Universitario Dr. Peset /ID# 159484

location_facility: Assaf Harofeh Medical Center /ID# 157182

location_facility: Sheffield Children's NHS Foundation Trust /ID# 130370

location_facility: The Lady Davis Carmel Medical Center /ID# 151519

location_facility: Hospital Universitario Vall d'Hebron /ID# 146015

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 150097

location_facility: Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 147538

location_facility: CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266

location_facility: Hospital General de Granollers /ID# 140882

location_facility: Univ California, San Francisco /ID# 141312

location_facility: Columbia Univ Medical Center /ID# 144475

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572

location_facility: Edmond And Lily Safra Children /ID# 148730

location_facility: Alder Hey Children's NHS Foundation Trust /ID# 138013

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 141667

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 137235

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029

location_facility: Duplicate_Ha'Emek Medical Center /ID# 156316

location_facility: Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347

location_facility: Rady Children's Hospital San Diego /ID# 140883

location_facility: Private practice: Dr. Shervin Rabizadeh /ID# 137269

location_facility: Medical University of South Carolina /ID# 144473

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962

location_facility: Hospital Universitario Vall d'Hebron /ID# 141778

location_facility: University Of Vermont Medical /ID# 137263

location_facility: Multicare Institute for Research and Innovation /ID# 152120

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 131590

location_facility: Froehlich Gemeinschaftspraxis /ID# 127975

location_facility: Compl Hospital Univer de Vigo /ID# 136999

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 165738

location_facility: Massachusetts General Hospital /ID# 141552

location_facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781

location_facility: ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829

location_facility: Hospital Universitario Central de Asturias /ID# 163053

location_facility: Hospital Universitari Son Espases /ID# 147446

location_facility: Birmingham Women's and Children's NHS Foundation Trust /ID# 136631

location_facility: Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410

location_facility: Emory Midtown Infectious Disease Clinic /ID# 144274

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460

location_facility: Universitaetsklinikum Aachen /ID# 126591

location_facility: Children's Hospital Colorado /ID# 137261

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592

location_facility: Children's Hospital Oklahoma /ID# 144047

location_facility: General Hospital of Thessaloniki Gennimatas /Id# 163658

location_facility: Univ Alabama, Birmingham CCC /ID# 146060

location_facility: Hospital Universitario Severo Ochoa /ID# 141545

location_facility: Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358

location_facility: University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 141310

location_facility: Universitaetsklinikum Regensburg /ID# 137140

location_facility: CCA Braga - Hospital de Braga /ID# 138269

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 127810

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 128256

location_facility: Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462

location_facility: Hospital Universitario 12 de Octubre /ID# 136998

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013

location_facility: SUNY Upstate Medical University /ID# 148437

location_facility: Fakultni nemocnice Hradec Kralove /ID# 128521

location_facility: Azienda Sanitaria Locale di Pescara /ID# 141307

location_facility: Hospital Universitario y Politecnico La Fe /ID# 141847

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438

location_facility: Duplicate_Universitaetsklinikum Freiburg /ID# 130010

location_facility: Nemours Children's Health System /ID# 148498

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 147441

location_facility: Universitaetsklinikum Erlangen /ID# 137274

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809

location_facility: Manchester University NHS Foundation Trust /ID# 128476


title: A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)

acronym: EU-STAR

summary: To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

lead_sponsor: DFINE Inc.

location_country: Germany France Italy

location_facility:
Goethe-Universität Frankfurt am Main
Cardarelli Hospital Naples, Italy
Policlinico Tor Vergata
Ospedale di Treviso Ca' Foncello
Otto-von-Guericke-Universität Magdeburg
Universität zu Köln
Universitätsklinikum Bonn
Nouvel Höpital Civil


title: A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-Induced Photochemical Internalisation (PCI) of Gemcitabine in Patients With Advanced Inoperable Cholangiocarcinomas

lead_sponsor: PCI Biotech AS

location_country:
Norway
Germany
France
United Kingdom

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

summary: This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable cholangiocarcinomas.


title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

summary: To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

ReferenceCitation: Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15.

ReferenceCitation: Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18.

ReferenceCitation: Messika-Zeitoun D, Nickenig G, Latib A, Kuck KH, Baldus S, Schueler R, La Canna G, Agricola E, Kreidel F, Huntgeburth M, Zuber M, Verta P, Grayburn P, Vahanian A, Maisano F. Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes. Eur Heart J. 2019 Feb 1;40(5):466-472. doi: 10.1093/eurheartj/ehy424.

ReferenceCitation: Nickenig G, Hammerstingl C, Schueler R, Topilsky Y, Grayburn PA, Vahanian A, Messika-Zeitoun D, Urena Alcazar M, Baldus S, Volker R, Huntgeburth M, Alfieri O, Latib A, La Canna G, Agricola E, Colombo A, Kuck KH, Kreidel F, Frerker C, Tanner FC, Ben-Yehuda O, Maisano F. Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005.

lead_sponsor: Edwards Lifesciences

location_country: Italy Switzerland France Israel Netherlands Germany

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

location_facility: Zentrum für Kardiologie, Universitätsmedizin Mainz

location_facility: Universitätskliniken zu Köln Klinik III Innere Medizin

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II


summary:
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary vascular resistance, which leads to right ventricular failure. Despite being recently the object of greater attention and despite therapeutic advances, pulmonary hypertension due to SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients prospectively followed in the "European League Against Rheumatism Scleroderma Trials and Research" (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some previous data have suggested the protective effects of calcium channel blockers on the development of pulmonary hypertension, the potential preventive effects of vasodilators for the prevention of Pulmonary hypertension have not been determined yet. In addition to be considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids, endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also be used for this indication.

This observational trial is one out of five observational trials of the collaborative project "To decipher the optimal management of systemic sclerosis" (DeSScipher).

Aim of this observational trial is:

- to compare the outcomes of adult and juvenile SSc patients who are at high risk of developing pulmonary hypertension and are receiving either different vasodilator treatments or no vasodilator treatment.

lead_sponsor: University of Paris 5 - Rene Descartes

location_country:
United Kingdom
Italy
Switzerland
Hungary
France
Germany

location_facility: University of Zurich, Department of Rheumatology

location_facility: Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

location_facility: University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

location_facility: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

location_facility: Royal Free Hospital, University College London

location_facility: The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

location_facility: Centre for Pediatric Rheumatology, Klinikum Eilbek

location_facility: Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: Pecsi Tudomanyegyetem - University of Pecs

location_facility: Felix-Platter Spital, University of Basel


summary:
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.

Aim of this observational trial is:

To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria

Thus, the observational trial consist of a prevention arm and a healing arm.

ReferenceCitation: Blagojevic J, Bellando-Randone S, Abignano G, Avouac J, Cometi L, Czirják L, Denton CP, Distler O, Frerix M, Guiducci S, Huscher D, Jaeger VK, Lóránd V, Maurer B, Nihtyanova S, Riemekasten G, Siegert E, Tarner IH, Vettori S, Walker UA, Allanore Y, Müller-Ladner U, Del Galdo F, Matucci-Cerinic M; EUSTAR co-workers. Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey. Arthritis Res Ther. 2019 Jan 24;21(1):35. doi: 10.1186/s13075-019-1822-1.

lead_sponsor: marco matucci cerinic


title: A Two-part, Single- and Two Arm Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy (in Part 2 Only) of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies

summary: Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies

primary_purpose: Prevention

ReferenceCitation: Dertschnig S, Gergely P, Finke J, Schanz U, Holler E, Holtick U, Socié G, Medinger M, Passweg J, Teshima T, Stylianou C, Oehen S, Heim D, Bucher C. Mocravimod, a selective S1PR modulator in allogeneic hematopoietic stem cell transplantation for malignancy. Transplant Cell Ther. 2022 Nov 4. pii: S2666-6367(22)01741-9. doi: 10.1016/j.jtct.2022.10.029. [Epub ahead of print]

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany France Switzerland


summary:
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.

lead_sponsor: Gabriele Valentini


acronym: IBUPROFEN LOZENGE IN ACUTE SORE THROAT PAIN

title: Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

lead_sponsor: Pierre Fabre Medicament

ReferenceCitation: Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

location_country:
Germany
France
United Kingdom
Latvia

summary: The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.


title: Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer

acronym: SUNRISES

summary: The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.

ReferenceCitation: Rodriguez-Vida A, Bamias A, Esteban E, Saez MI, Lopez-Brea M, Castellano D, Caballero C, Gonzalez-Larriba JL, Calvo E, Macia S, Ravaud A, Bellmunt J. Randomised Phase II study comparing alternating cycles of sunitinib and everolimus vs standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study). BJU Int. 2020 Nov;126(5):559-567. doi: 10.1111/bju.15165. Epub 2020 Aug 2.

lead_sponsor: Associació per a la Recerca Oncologica, Spain

location_country: France Spain Greece

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario Virgen de la Victoria


title: Post-Market Surveillance Registry for the NeoChord DS1000

summary: To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

lead_sponsor: NeoChord

location_country: Italy Lithuania Switzerland France Germany

location_facility: Vilniaus Universiteto ligonines Santariskiu

location_facility: Bordeaux Heart University Hospital (CHU)


title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

summary: The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

primary_purpose: Supportive Care

lead_sponsor: Cook Group Incorporated

location_country:
Netherlands
United States
Canada
France

location_facility:
Hôpital Edouard Herriot
University of Pittsburgh Medical Center
Borland-Groover Clinic
Centre Hospitalier de 1'Université
Erasmus Medish Centrum
Moffitt Cancer Center
University of Virginia Health System
University of Colorado Hospital
Hôpital L'Archet 2
Indiana University Hospital
St. Michael's Hospital
Wake Forest Baptist Medical Center


title: A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

acronym: MONARCH 1

summary: The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

ReferenceCitation: Dickler MN, Tolaney SM, Rugo HS, Cortés J, Diéras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR(+)/HER2(-) Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22. Erratum in: Clin Cancer Res. 2018 Nov 1;24(21):5485.

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

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Spain
Belgium

location_facility: The Center for Cancer and Blood Disorders

location_facility: Northern Arizona Hematology & Oncology Associates

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

location_facility: HOPE Hematology Oncology Physicians and Extenders

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center


title: Influence of the Pre-existing Cognitive Status on the Outcome in Patients Treated by Thrombolytic Therapy for Acute Cerebral Ischaemia

acronym: OPHELIE-COG

summary:
At the acute stage of cerebral ischaemia, the only effective drug that increases the proportion of patients who survive without dependency is thrombolytic therapy by intravenous (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice with similar results than in trials, in various places of the world including Europe and Japan.

Stroke and dementia are closely related. About one patient in ten has dementia before a first-ever stroke, and more than one in three has dementia after a recurrent stroke. Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing cognitive impairment without dementia is associated with a higher rate of institutionalisation within 3 years. In many patients cognitive impairment is due to the summation of the effects of vascular and Alzheimer lesions of the brain.

More and more patients nowadays who are eligible for rt-PA are already known as demented at admission. A retrospective study conducted in a cohort of patients with dementia who had an ischaemic stroke and were treated by rtPA suggested that there is no increased risk of cerebral bleeding and death as compared with non demented patients. However, pre-existing cognitive impairment is possibly associated with (i) an increased risk of bleeding in patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of rt-PA on the brain tissue.

Japanese patients differ from European patients by a higher risk of spontaneous intracranial haemorrhage, and a higher proportion of patients with small-vessel diseases.

The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment or dementia. The secondary objectives are to determine whether (i) they have an increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a poor outcome is lower than expected from the placebo group of randomised trials for patients with a similar range of baseline severity, and (iii) the influence of the cognitive state on outcome differs between Japanese and European patients.

lead_sponsor: University Hospital, Lille

location_country: Japan France

location_facility:
Lille University Hospital
Fukuoka-Higashi Medical center
Kyushu University
Kyushu Rosai Hospital
Steel Memorial Yawata Hospital
St. Mary's Hospital
Kawasaki Medical University
Fukuoka Redcross Hospital
Kyushu Medical Center


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

ReferenceCitation: Camidge DR, Barlesi F, Goldman JW, Morgensztern D, Heist R, Vokes E, Spira A, Angevin E, Su WC, Hong DS, Strickler JH, Motwani M, Dunbar M, Parikh A, Noon E, Blot V, Wu J, Kelly K. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 26:JCO2200739. doi: 10.1200/JCO.22.00739. [Epub ahead of print]

ReferenceCitation: Camidge DR, Morgensztern D, Heist RS, Barve M, Vokes E, Goldman JW, Hong DS, Bauer TM, Strickler JH, Angevin E, Motwani M, Parikh A, Sun Z, Bach BA, Wu J, Komarnitsky PB, Kelly K. Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Clin Cancer Res. 2021 Nov 1;27(21):5781-5792. doi: 10.1158/1078-0432.CCR-21-0765. Epub 2021 Aug 23.

ReferenceCitation: Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306. doi: 10.1200/JCO.2018.78.7697. Epub 2018 Oct 4. Erratum in: J Clin Oncol. 2019 Jan 20;37(3):261.

location_country:
Taiwan
Italy
Finland
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Netherlands

location_facility: Summit Medical Group-Florham Park /ID# 217651

location_facility: Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077

location_facility: Univ of Colorado Cancer Center /ID# 123759

location_facility: Universitair Ziekenhuis Antwerpen /ID# 170118

location_facility: University of California, Los Angeles /ID# 148295

location_facility: Virginia Cancer Specialists - Fairfax /ID# 165708

location_facility: Taipei Veterans General Hosp /ID# 217392

location_facility: National Cancer Center Hospital /ID# 217571

location_facility: University of Texas MD Anderson Cancer Center /ID# 154648

location_facility: AP-HM - Hopital de la Timone /ID# 151570

location_facility: Yonsei University Health System Severance Hospital /ID# 217333

location_facility: Dana-Farber Cancer Institute /ID# 168782

location_facility: The University of Chicago Medical Center /ID# 136995

location_facility: Radboud Universitair Medisch Centrum /ID# 246908

location_facility: Washington University-School of Medicine /ID# 143798

location_facility: National Cancer Center Hospital East /ID# 217570

location_facility: China Medical University Hospital /ID# 217494

location_facility: Herbert Herman Cancer Center /ID# 149858

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 129805

location_facility: Northwell Health - Monter Cancer Center /ID# 218170

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378

location_facility: National Taiwan University Hospital /ID# 167173

location_facility: Massachusetts General Hospital /ID# 129804

location_facility: Mary Crowley Cancer Research /ID# 123760

location_facility: National Cheng Kung University Hospital /ID# 167175

location_facility: Montefiore Medical Park at Eastchester /ID# 218445


title: Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

acronym: ARTFORCE

summary:
This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

ReferenceCitation: Heukelom J, Hamming O, Bartelink H, Hoebers F, Giralt J, Herlestam T, Verheij M, van den Brekel M, Vogel W, Slevin N, Deutsch E, Sonke JJ, Lambin P, Rasch C. Adaptive and innovative Radiation Treatment FOR improving Cancer treatment outcomE (ARTFORCE); a randomized controlled phase II trial for individualized treatment of head and neck cancer. BMC Cancer. 2013 Feb 22;13:84. doi: 10.1186/1471-2407-13-84.

lead_sponsor: The Netherlands Cancer Institute

location_country:
United Kingdom
Spain
Sweden
France
Netherlands

location_facility:
Gustave Roussy Cancer Institute
University Medical Centre Utrecht
Maastro Clinic
Christie Hospital NHS Trust
Netherlands Cancer Institute
Universitair Medisch Centrum Groningen
Karolinska Institute
University Hospital Vall d'Hebron
Erasmus Medical Centre

intervention_type: Radiation