title: A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment

summary: To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

lead_sponsor: Pfizer

location_country:
Brazil
Spain
Korea, Republic of
France
Belgium
Germany
Slovakia


title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

acronym: HomeCARE

summary: In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Ellery S, Pakrashi T, Paul V, Sack S. Predicting mortality and rehospitalization in heart failure patients with home monitoring--the Home CARE pilot study. Clin Res Cardiol. 2006;95 Suppl 3:III29-35. Review.

ReferenceType: derived

ReferenceCitation: Sack S, Wende CM, Nägele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study. Eur J Heart Fail. 2011 Sep;13(9):1019-27. doi: 10.1093/eurjhf/hfr089.

lead_sponsor: Biotronik SE & Co. KG

location_country:
Spain
Italy
Austria
Latvia
Netherlands
United Kingdom
Czech Republic
France
Israel
Germany

location_facility: Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hadasit Medical Research Services & Development Ltd.

location_facility: P. Stradina Clinical University Hospital

location_facility: Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski

location_facility: CHRU Hôpital de Villeneuve, Cardiologie B

location_facility: Gemeinschaftpraxis für Kardiologie und Angiologie

location_facility: Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo

location_facility: CHRU Hôpital de Villeneuve, Cardiologie A

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: Dose Optimization Study of Idelalisib in Follicular Lymphoma

summary: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

study_start_date_type: Actual

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
France
Israel
Romania
Czechia

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia

location_facility: Centrum Onkologii Instytut im.Marii Sklodowskiej Curie

location_facility: Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku

location_facility: Hospital Genereal Universitario Morales Meseguer

location_facility: Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie

location_facility: Torbay and South Devon NHS Foundation Trust

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Ospedale Policlinico San Martino IRCCS-Clinica Ematologica

location_facility: Centre Hospitalier d'Avignon-Hopital Henri Duffaut

location_facility: A.S.U. Integrata Santa Maria della Misericordia

location_facility: Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica

location_facility: Institut Catala d'Oncologia Hospital Universitari de Bellvitge

location_facility: Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative

location_facility: Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol

location_facility: London North West University Healthcare NHS Trust

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Hospital General Universiario Gregorio Maranon

location_facility: Wojewodzki Szpital Specjalistyczny w Legniicy

intervention_type: Drug

status_simplified: Unknown


title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

acronym: OPTI-MIND 2

summary: The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany
Slovakia

location_facility: Service de cardiologie, CHU Nancy-Brabois

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO

location_facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari


title: Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy

acronym: PRINT

summary:
Study Design & Objectives:

Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.

To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.

Ancillary study objective:

To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

time_perspective: Cross-Sectional

lead_sponsor: TcLand Expression S.A.

location_country: Spain Italy Lithuania Canada Hungary France Romania Slovakia

location_facility:
Location n°8
Location n°17
Location n°35
Location n°27
Location n°29
Location n°34
Location n°24
Location n°39
Location n°3
Location n°38
Location n°11
Location n°22
Location n°26
Location n°5
Location n°18
Location n°12
Location n°20
Location n°14
Location n°7
Location n°41
Location n°13
Location n°28
Location n°33
Location n°6
Location n°36
Location n°9
Location n°37
Location n°25
Location n°15
Location n° 19
Location n°23
Location n°31
Location n°16
Location n°10
Location n°21
Location n°40
Location n°30


title: A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II

summary: This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

lead_sponsor: Bayer

location_country:
Spain
Italy
Netherlands
France
South Africa
Belgium
Germany


title: A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

summary: A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Czech Republic
Switzerland
Sweden
France
Belgium
Germany


title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

summary: The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

ReferenceCitation: Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. Erratum in: J Clin Psychiatry. 2009 Dec;70(12):1729.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Russian Federation
Sweden
United States
France
Germany

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


status: Active, not recruiting

acronym: COBRA

intervention_type: Biological

title: Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab

study_completion_date_type: Anticipated

lead_sponsor: LEO Pharma

type: Other Identifier

source: euctr

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

enrollment_type: Anticipated

location_country:
Spain
Greece
Austria
Italy
United Kingdom
Switzerland
Sweden
France
Belgium
Germany

location_facility:
LEO Pharma Investigational Site 1
LEO Pharma Investigational Site 2
LEO Pharma investigational site
Pharma Investigational Site
LEO Pharma Investigational Site

summary: The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

status_simplified: Ongoing


title: A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

lead_sponsor: Janssen Sciences Ireland UC

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

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

location_country:
Poland
Spain
Italy
United Kingdom
France
Belgium
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

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

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

summary: The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).


title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Innate Pharma

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire- Hôpital Nord Laennec


title: TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.

summary:
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

lead_sponsor: Takeda

location_country:
Poland
Spain
Greece
Austria
Italy
Netherlands
Russian Federation
Sweden
France
Belgium
Germany

intervention_type: Procedure


title: Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative (ER, PR, Her2 Negative) Locally Advanced Non-resectable and/or Metastatic Breast Cancer

summary: The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer

lead_sponsor: R-Pharm

location_country:
Poland
Spain
Italy
Austria
Greece
Czech Republic
France


title: A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin

summary: The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.

ReferenceCitation: Lenz O, de Bruijne J, Vijgen L, Verbinnen T, Weegink C, Van Marck H, Vandenbroucke I, Peeters M, Simmen K, Fanning G, Verloes R, Picchio G, Reesink H. Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy. Gastroenterology. 2012 Nov;143(5):1176-1178.e6. doi: 10.1053/j.gastro.2012.07.117. Epub 2012 Aug 8.

ReferenceCitation: Manns M, Reesink H, Berg T, Dusheiko G, Flisiak R, Marcellin P, Moreno C, Lenz O, Meyvisch P, Peeters M, Sekar V, Simmen K, Verloes R. Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial. Antivir Ther. 2011;16(7):1021-33. doi: 10.3851/IMP1894.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Poland
United Kingdom
Netherlands
France
Belgium
Germany


title: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

summary: The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

status: Recruiting

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

location_country:
Poland
Taiwan
Spain
Netherlands
Korea, Republic of
France
China
Belgium
Germany
Czechia

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou

location_facility: Hospital Universitari General de Catalunya

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Tianjin Medical University General Hospital

location_facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

location_facility: Centre Hospitalier Universitaire Toulouse - Cité de la Santé

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Centre Hospitalier Universitaire Régional de Nancy

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Beijing Tiantan Hospital Affiliated to Capital Medical University

location_facility: Xuanwu Hospital Capital Medical University

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: ISPG - Institut für Studien zur Psychischen Gesundheit

location_facility: Private Practice - Dr. Urszula Chyrchel- Paszkiewicz

location_facility: IBISMED Wielospecjalistyczne Centrum Medyczne

location_facility: Charité Universitätsmedizin Berlin - Campus Berlin Buch

location_facility: Hôpital des Charpennes - Hospices Civils de Lyon (HCL)

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

location_facility: National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Universitätsmedizin Göttingen - Georg-August-Universität

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Beijing Anding Hospital - Affiliated Capital University of Medical Science

location_facility: The First Hospital of Hebei Medical University

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

location_facility: Klinikum Rechts Der Isar Der Technischen Universität München

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: West China Hospital of Sichuan University

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

location_facility: Seoul National University Bundang Hospital

location_facility: Beijing Peking Union Medical College Hospital

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine

location_facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

location_facility: Osrodek Badawczo - Naukowo - Dydaktyczny Chorob Otepiennych w Scinawie - Osrodek Alzheimerowski Sp. z o.o.

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Xiangya Hospital Central South University

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Taipei Medical University Shuang Ho Hospital


title: A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

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

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Portugal
Austria
Argentina
India
Israel
Turkey
Mexico
Brazil
Canada
Switzerland
China
Germany
Taiwan
Georgia
Korea, Republic of
France

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Kobe University Hospital - Dept of Oncology/Hematology

location_facility: Centre Francois Baclesse - Service d'Oncologie Medicale

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Complejo Hospitalario Universitario A Coruña - Servicio de Oncologia

location_facility: National Cancer Center Hospital East - Dept of Head and Neck Medical Oncology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Cancer Institute Hospital of JFCR - Dept of Medical Oncology

location_facility: Centre Georges François Leclerc - Oncologie Médicale

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) - Oncologia Medica

location_facility: Royal Surrey County Hospital - Dept of Oncology

location_facility: Centre Oscar Lambret - service de cancerologie gynecologique

location_facility: ICO - Site René Gauducheau - Service d'Oncologie medicale

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: CHU Tours - Hôpital Bretonneau - Service d'Oncologie Médicale

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: Pusan National University Yangsan Hospital

location_facility: S.C Radiotherapy Center Cluj S.R.L - Parent

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: A.O.U. Policlinico di Modena - U.O. Oncologia

location_facility: Tohoku University Hospital - Dept of Otorhinolaryngology/Head and Neck Surgery

location_facility: Hospital Universitario Fundacion Jimenez Diaz - Oncology

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - U.O.C. di Oncologia B

location_facility: CHU Bordeaux - Service d'Oncologie Médicale

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia

location_facility: NHO Shikoku Cancer Center - Dept of Head and Neck Surgery

location_facility: Universitaetsspital Basel - Klinik fuer Strahlentherapie und Radioonkologie

location_facility: Ospedale San Raffaele - U.O. di Oncologia Medica

location_facility: University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology

location_facility: Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médicale

location_facility: Centre Henri Becquerel - Service de radiothérapie

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

location_facility: Hokkaido University Hospital - Dept of Otorhinolaryngology

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Radioterapia 1

location_facility: National Cancer Center Hospital - Dept of Gastroenterology

location_facility: High Technology Medical Center, University Clinic

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals-, Nasen- und Ohrenheilkunde

location_facility: Hôpital de la Timone - Oncologie Médicale Hématologie & Soins Palliatifs

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Institut Claudius Regaud - service de Radiothérapie

location_facility: Centre Hospitalier Privé Saint-Gregoire (Rennes) - Cancerologie

location_facility: Hiroshima University Hospital - Dept of Otorhinolaryngology/ Head and Neck Surgery

location_facility: Aichi Cancer Center Hospital - Dept of Head and Neck Surgery

location_facility: Fakultni nemocnice Bulovka - Dept of Radiodiagnosticka klinika

location_facility: Cliniques Universitaires Saint-Luc - STL

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Tumori della Testa e del Collo

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Nagoya University Hospital - Dept of Otorhinolaryngology

location_facility: Hospital Beneficência Portuguesa de São Paulo

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Gazi University Medical Faculty - Parent Account

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)

location_facility: Krankenhaus der barmherzigen Schwestern Linz - Abteilung für HNO

location_facility: Institut Curie - site de Paris - Service d'Oncologie Médicale

location_facility: Osaka International Cancer Institute - Dept of Head and Neck Surgery

location_facility: Institut Régional du Cancer de Montpellier - Service de Professeur Senesse

location_facility: Ospedale Oncologico Armando Businco - Divisione di Oncologia Medica II

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A

location_facility: Kagawa University Hospital - Dept of Oncology

location_facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie

location_facility: S.C Oncocenter Oncologie Clinica S.R.L - parent

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hopital Prive Drome Ardeche - Service D Oncologie

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie

location_facility: Medipol University Medical Faculty - Parent

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals - Servicio Oncologia

location_facility: Hopital Tenon - service radiologie et imagerie medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo - Div. di Oncologia Medica ed Ematologia

location_facility: Hospital Universitario Lucus Augusti - Oncology

location_facility: KABEG-Klinikum Klagenfurt - Department of Internal Medicine

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

location_facility: Universitaetsklinikum Regensburg - Innere Medizin III Haematologie, Onkologie

location_facility: Universitaetsmedizin Rostock - Klinik und Poliklinik für Strahlentherapie

location_facility: Hyogo Cancer Center - Dept of Head and Neck Surgery

location_facility: Okayama University Hospital - Dept of Otorhinolaryngology

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L - parent

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Izmir Medicalpark Hospital - Izmir Medicalpark Hastanesi

location_facility: Shengjing Hospital of China Medical University

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - U. Operativa di Immunoterapia e Terapia Cellulare

location_facility: IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Centro Hospitalar de São João, E.P.E - Serviço de Oncologia

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica

location_facility: Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina - Pesquisa Clínica

location_facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

location_facility: Oncosite - Centro de Pesquisa Clinica e Oncologia

location_facility: Centre Azureen Cancerologie - Service De Radiotherapie

location_facility: Institut Gustave Roussy - Oncologie Médicale

location_facility: Xiangya Hospital, Central South University

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

location_facility: Saitama Cancer Center - Dept of Head and Neck Surgery

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

location_facility: Hospital Universitario Virgen del Rocio - Oncology Service

location_facility: Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization

location_facility: NHO Hokkaido Cancer Center - Dept of Oral Oncology Surgery

location_facility: CIUSSS du Centre Ouest de l'lle de Montreal - Not Applicable

location_facility: Fakultni nemocnice Kralovske Vinohrady - Dept of Radioterapeuticka a onkologicka klinika

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

location_facility: CHI Toulon La Seyne - Hôpital Sainte Musse - Service d'Onco-Hematologie

location_facility: CHU Brest - Hôpital Morvan - Service d'Oncologie Médicale

location_facility: Mount Vernon Hospital - Dept of Oncology

location_facility: Trakya University Medical Faculty - Parent Account

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: Hospital Regional Universitario de Malaga - Oncology Dept

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Kindai University Hospital - Dept of Oncology

location_facility: Saitama Medical University International Medical Center - Dept of Otorhinolaryngology/ Head and Neck Surgery

location_facility: University of Cincinnati Cancer Institute

location_facility: Perlmutter Cancer Center at NYU Langone Hospital ae Long Island

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

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centre Hospitalier de la Croix Rousse - Service ORL et chirurgie cervico-faciale

location_facility: NHO Kyushu Cancer Center - Dept of Head and Neck Surgery

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Yokohama City University Hospital - Dept of Otorhinolaryngology

location_facility: University of Alabama at Birmingham - Dept of Radiation Oncology

location_facility: Complejo Hospitalario Universitario Insular Materno-Infantil - Servicio de Oncologia

location_facility: LKH - Universitätsklinikum Graz - HNO-Universitätsklinik

location_facility: Hospital de Braga - Serviço de Oncologia Medica

intervention_type: Radiation


title: A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease

summary:
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD
Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

primary_purpose: Basic Science

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:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Iceland
Japan
Romania
Czechia
Poland
Hong Kong
Austria
Australia
Argentina
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
Finland
Korea, Republic of
France
Netherlands

location_facility: The Cardiac and Vascular Institute Research

location_facility: ICBA - Instituto Cardiovascular de Buenos Aires

location_facility: Ambulatory for Individual Practice for Specialized Medical Care - Kardio EOOD

location_facility: Van Yuzuncu Yil Universitesi Dursun Odabas Tip Merkezi

location_facility: Novant Health Heart and Vascular Institute

location_facility: The Sakakibara Heart Institute of Okayama

location_facility: Clinique des Maladies Lipidiques de Quebec Incorporated

location_facility: NIHR Patient Recruitment Centre Newcastle

location_facility: Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Da Universidade de Sao Paulo

location_facility: MUDr Ladislava Harrerova, kardiologicka ordinace

location_facility: GenesisCare HeartCare Victoria - Berwick

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Centro Paulista de Investigacoes Clinicas Cepic

location_facility: Azienda Ospedaliera Sant Anna e San Sebastiano

location_facility: Kawaguchi Cardiovascular and Respiratory Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

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

location_facility: Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand

location_facility: Del-budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz

location_facility: Advanced Research for Health Improvement, LLC

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Dr Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: East Coast Institute for Research LLC at Northeast Florida Endocrine and Diabetes Research Associate

location_facility: Cardiovascular Research of Northwest Indiana LLC

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: Instituto Latinoamericano de Investigaciones Medicas CIDIM-ILAIM

location_facility: Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Baylor Scott and White Heart and Vascular Hospital-Dallas

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Seoul National University Bundang Hospital

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: GenesisCare Adelaide Cardiology Practice - Leabrook Clinic

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Tidewater Physicians Multispecialty Group Clinical Research

location_facility: Northeast Georgia Medical Center Wisteria Building

location_facility: Afyonkarahisar Saglik Bilimleri Universitesi Hastanesi

location_facility: Hornicka nemocnice s poliklinikou spol sro

location_facility: Onze Lieve Vrouw Ziekenhuis - campus Aalst

location_facility: Saint Johns Center for Clinical Research

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Lapeyronie

location_facility: South Texas Cardiovascular Consultants PLLC

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Multiprofile Hospital for Active Treatment - Haskovo AD

location_facility: WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

location_facility: Associacao de Amparo a Saude Ensino e Pesquisa

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum

location_facility: GenesisCare Wesley Hospital Auchenflower

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care

location_facility: Centro Medico Dra LAURA MAFFEI e Investigacion clinica aplicada

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Fundacion Cardiovascular de Aguascalientes AC

location_facility: Jacksonville Center for Clinical Research

location_facility: Kardiologische Praxis Doktor Jens Taggeselle

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Adnan Menderes Universitesi Medical Faculty

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: Research Institute of McGill University Health Center - Glen Site

location_facility: Konstantopoulio - Agia Olga Hospital of Nea Ionia

location_facility: Institut de recherches cliniques de Montreal

location_facility: Renown Institute for Heart and Vascular Health

location_facility: Procliniq Investigación Clínica Sa de Cv

location_facility: Dr Nagy Laszlo Kardiologiai maganrendeles es SMO

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: CMI Cardiologie - Dr. Mercea Corina Delia

location_facility: Dr Lakatos Ferenc Private Cardiology Practice

location_facility: MUDr Zbynek Kosek, kardiologicka ambulance sro

location_facility: Instituto de Investigaciones Clinicas de Cordoba

location_facility: Japan Community Health care Organization Kyushu Hospital

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Instituto de Pesquisa em Endocrinologia Clinica IPEC

location_facility: FZ Pesquisa e Servicos em Cardiologia LTDA

location_facility: Institut klinicke a experimentalni mediciny

location_facility: ICM - Instituto do Coração de Marilia EPP

location_facility: Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

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

location_facility: Grandview Medical Center Affinity Cardiovascular Specialists, LLC

location_facility: Mersin Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Johns Hopkins University School of Medicine

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carita

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: London Health Sciences Centre, University Hospital

location_facility: Alaska Cardiovascular Research Foundation

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Westside Medical Associates of Los Angeles

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: Kardio Vaclavik sro, Interni a kardiologicka ambulance

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spolka z ograniczona odpowiedzialnos

location_facility: Center for Clinical and Basic Research Tallinn

location_facility: Kardiologijos ir reabilitacijos klinika, UAB

location_facility: Hamilton Health Sciences Hamilton General Hospital

location_facility: Diagnostic-Consultative Center Ascendent OOD

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est, Hopital Louis Pradel

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Jaroslaw Ciosek Rajtar-Medica Centrum Medyczne

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Centro de Especialidades Medicas - Cemedic

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

location_facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division

location_facility: Hospital Sao Francisco da Santa Casa de Misericordia de Porto Alegre

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: NIHR Patient Recruitment Centre Bradford

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II w Zamosciu

location_facility: Millennium Physician Group, LLC dba Charlotte Heart Group Research Center

location_facility: Clinical Best Solutions Sp zoo Spolka komandytowa Gabinet Lekarski

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Kardiologicke centrum MUDr Janky Skrobakove sro

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

location_facility: GenesisCare HeartCare Western Australia - Joondalup

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Instituto de Investigaciones Clinicas de San Nicolas

location_facility: Niigata University Medical and Dental Hospital

location_facility: Ciad - Consultorio Integral de Atencion al Diabetico

location_facility: Yokohama Sakae Kyosai Hospital Federation of National Public Service Personnel Mutual Association

location_facility: National Hospital Organization Shizuoka Medical Center

location_facility: Instituto de Ensino e Pesquisa do Hospital da Bahia

location_facility: Instituto de Cardiologia do Rio Grande do Sul

location_facility: LMC Clinical Research Incorporated Thornhill

location_facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas

location_facility: University Hospitals Cleveland Medical Center

location_facility: American Heart of Poland Spolka Akcyjna Polsko-Amerykanskie Kliniki Serca

location_facility: Cardiology Associates of Fairfield County PC

location_facility: CIPREC - Centro de Investigacion y Prevencion Cardiovascular

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Med Partners, Inc dba Premiere Medical Center, Inc

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Diabetologische Gemeinschaftspraxis Dr Schaper und Dr Faulmann

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo

intervention_type: Other


title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation

summary: This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country: Portugal Spain Italy Austria Netherlands Canada Switzerland Sweden Hungary France Belgium Norway Germany Czechia

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Charite Paediatric Pulmonology Department

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Azienda Ospedaliera Universitaria Federico II (Adults)

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Centre Hospitalier Universitaire De Reims, Hopital Sebastopol

location_facility: Klinik fur Kinder- und Jugendmedizin, Universitatsklinikum Munster

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: University of Alberta Hospital, Edmonton Clinic

location_facility: Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

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


title: Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group

acronym: COLUMBUS-AD

summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

ipd_sharing_description: Access to de-identified patient-level data in response to scientifically valid research proposals will be provided 30 days after CHMP opinion. All requests from qualified researchers for access to Columbus AD clinical data and information will be managed through a dedicated Pierre Fabre portal.

lead_sponsor: Pierre Fabre Medicament

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
South Africa
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Greece
France
Netherlands

location_facility: Centre Hospitalier de Pau - Hôpital François Mitterrand

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: CHI Kharkiv Regional Clinical Oncological Center

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

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

location_facility: MI Kirovograd Regional Oncological Dispensary

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

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

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: Hospital General Universitario de Valencia

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Azienda Sanitaria Ospedaliera S.Croce e Carle

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

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

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

location_facility: Anticancer Hospital of Thessaloniki " Theagenio"

location_facility: Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital

location_facility: AMO - Assistência Multidisciplinar em Oncologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Azienda Sanitaria Universitaria Friuli Centrale

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: CIUSSS du Centre Ouest de l'lle de Montreal

location_facility: Hospital General Universitario Gregorio Marañon

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

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Regional Universitario de Malaga

location_facility: SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: London Health Sciences Centre (LHSC) - Victoria Hospital

location_facility: CNE"City Clin Hosp#4"of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Landeskrankenhaus - Universitaetsklinikum Graz

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino


title: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

acronym: SAFFRON

summary: Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Argentina
Israel
Turkey
Brazil
Canada
Switzerland
China
Germany
Bulgaria
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile


title: Acute Respiratory Infections Global Outpatient Study

acronym: ARGOS

summary: The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.

primary_purpose: Other

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Thailand
Korea, Republic of
United States
France
China
Malaysia
Colombia
Japan
Germany

location_facility: Shanghai Fengxian District Central Hospital

location_facility: Nucleo di Cure Primarie della Val Pescara

location_facility: CCT Research at South Ogden Family Medicine

location_facility: Washington University School of Medicine

location_facility: MultiCare Health Systems for Research and Innovation

location_facility: Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych

location_facility: Hospital General de Agudos Donacion Francisco Santojanni

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Centro de Investigación Clínica Gramel S.C.

location_facility: Solano y Terront Servicios Médicos Ltda.

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

location_facility: Wake Forest Baptist Health Urgent Care Clemmons

location_facility: NZOZ Leczniczo-Rehabilitacyjny Ośrodek Medycyny Rodzinnej

location_facility: CHU Tours - Hopital Bretonneau - Maladies Infectieuses

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Programa de Estudio y Control de Enfermedades Tropicales

location_facility: Hospital Municipal de Vicente Lopez Dr. Bernardo Houssay

location_facility: Royal Devon and Exeter Hospital(Wonford)

location_facility: Fiel Family and Sports Medicine Clinical Research Advantage

location_facility: Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

location_facility: Impar Servicos Hospitalares S/A - Hospital Brasília

location_facility: Deshinee Moodley Meidicine Professional Corporation

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

location_facility: Innovative Research of West Florida, Incorporated

location_facility: Qianfoshan hospital of Shandong Province

location_facility: Shengjing Hospital of China Medical University

location_facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

location_facility: Ascension Medical Group - St. John Clinic Infectious Disease

location_facility: CMPC - Consultoria Médica e Pesquisa Clínica

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Urgent Care Clinical Trials at AFC Urgent Care

location_facility: Xiangya Hospital, Central South University

location_facility: Centro de Investigacion y Transferencia en Salud, Fundacion Santos y de la Garza Evia, IBP

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska

location_facility: Centre Hospitalier Départmental La Roche sur Yon

location_facility: Oaxaca Site Management Organization S.C.

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Fundação Universidade Federal de Mato Grosso do Sul

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Azienda Sanitaria Locale N. 2 Savonese - Presidio ospedaliero di Albenga - Ospedale Santa Corona

location_facility: Unidad de Proyectos Clínicos de Oriente UPCO

location_facility: Berliner Centrum f. Reise- und Tropenmedizin (BCRT)

location_facility: The 2nd Affiliated Hospital & Yuying Children's Hospital Wenzhou Medical University

location_facility: PharmaDUX Clinical Medical Research, LLC

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Centrum Innowacyjnych Terapii Sp. z o.o.

location_facility: Instituto Medico de La Fundacion Estudios Clinicos

intervention_type: Diagnostic Test


title: Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

summary:
The primary objective of this study is to compare overall survival (OS) of sacituzumab govitecan-hziy (SG) versus docetaxel in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/ programmed death ligand 1 (PD-L1) immunotherapy received either in combination or sequentially.

Participants will be randomly assigned in a 1:1 ratio to receive either SG or docetaxel.

lead_sponsor: Gilead Sciences

location_country:
Poland
Brazil
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
Mexico
Netherlands
United Kingdom
Puerto Rico
United States
France
Israel
Turkey
Belgium
Japan
Germany

location_facility: Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral

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

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Asklepios-Fachkliniken Munchen-Gauting,Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: Henry Dunant Hospital Center, 4th Oncology Department

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Pan American Center For Oncology Trials, LLC

location_facility: General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology

location_facility: Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii

location_facility: Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie

location_facility: zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica

location_facility: USOR - Arizona Oncology Associates Tucson - Wilmot

location_facility: Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung

location_facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Przychodnia Lekarska Komed Roman Karaszewski

location_facility: Panamerican Clinical Research S.A. de C.V

location_facility: ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

location_facility: Hospital de Clínicas de Porto Alegre - HCPA

location_facility: ASST Papa Giovanni XXIII, Oncologia Medica

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: AOU Policlinico G Rodlico-Oncologia Medica

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

location_facility: Hospital Clinicl universitario virgen de la Arrixaca

location_facility: Hospital Regional Universitario de Malaga-Hospital Civil

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Required Centre Hospitalier Regional de Rimouski

location_facility: University of Wisconsin Clinical Science Center

location_facility: East Suffolk and North Essex NHS Foundation Trust

location_facility: Peninsula & South Eastern Haematology and Oncology Group

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

location_facility: AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale

location_facility: Metropolitan General, Oncology department

location_facility: University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital

location_facility: Hospital Universitario Fundacion Jimenez Dias

location_facility: Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie

location_facility: Cryptex Investigación Clínica, S.A. de C.V.

location_facility: Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit

location_facility: Chu Montpellier Hopital Arnaud de Villeneuve

location_facility: University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology

location_facility: Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC

location_facility: Froedtert Hospital/Medical College of Wisconsin

location_facility: Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Florida Cancer Specialists (Administration and Drug Shipment)

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

location_facility: ASST Grande Ospedale Metropolitano Niguarda SC Oncologia

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: National Hospital Organization Himeji Medical Center


title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

summary: The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

location_country:
Denmark
Poland
United Kingdom
Greece
Austria
Australia
Ireland
Canada
Italy
Netherlands
New Zealand
Sweden
Hungary
Switzerland
United States
France
Israel
Belgium
Norway
Germany

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Washington University School of Medicine

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: University Hospital and UW Health Clinics

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Children's Hospital of the King's Daughters

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

location_facility: Schneider Children's Medical Center of Israel

location_facility: Centre hospitalier universitaire de Nancy, Hôpital de Braboi

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Charite Paediatric Pulmonology Department

location_facility: Spectrum Health Medical Group Adult Cystic Fibrosis Care Center

location_facility: Northwell Health- Long Island Jewish Medical Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Banner University of Arizona Medical Center

location_facility: The University of Texas Southwestern Medical Center

location_facility: CF Therapeutics Development Center of Western New York

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: St. Luke's Cystic Fibrosis Center of Idaho

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde

location_facility: University of Oklahoma Health Sciences Center

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Riley Hospital for Children at Indiana University Health

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

location_facility: University Hospital Limerick (Pediatrics)

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: General Hospital of Thessaloniki "Papanikolaou"

location_facility: University of Utah - Primary Children's Medical Center

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

location_facility: Nemours Children's Specialty Care, Pensacola

location_facility: University of Mississippi Medical Center

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Pediatric Hospital Polanki named of Maciej Płażyński

location_facility: Sheba Medical Center - The Edmond and Lili Safra Children's Hospital

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

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: University of Miami Miller School of Medicine

location_facility: Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: University of Arkansas for Medical Sciences

location_facility: Lund University Skanes Universitetssjukhus

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: University of California Davis Medical Center

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

location_facility: Institute of Tuberculosis and Lung Diseases

location_facility: Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)

summary: Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Croatia
Spain
Italy
Lithuania
United States
Mauritius
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Bulgaria
Denmark
Taiwan
Latvia
Estonia
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Cardiovascular Associates Research Main Center

location_facility: Novant Health Heart and Vascular Institute

location_facility: Advanced Research for Health Improvement LLC

location_facility: Clinical Trials Management, LLC Clinical Trials Mgmt-Covington

location_facility: Metro Health Univ of MI Health Metro Health U Of Mi Health

location_facility: University of Florida - Shands Jacksonville UF Health Jacksonville

location_facility: Akron Hospital Summa Health System Akron Hospital

location_facility: Stanford University Medical Center School of Medicine

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Emerson Clinical Research Institute, LLC

location_facility: Wake Forest U of Health Sciences-Cardiology Dept

location_facility: Alaska Cardiology Reserach Foundation, NFP

location_facility: Apex Cardiology Research Associates of Jackson

location_facility: North Shore Diabetes and Endocrine Associates

location_facility: The Heart Group Cardiovascular Associates Inc

location_facility: Methodist Physicians Clinic Heart Consultants

location_facility: Albany Medical College Div of Community Endocrinology

location_facility: Cardiovascular and Vein Center of Florida

location_facility: Adventist HealthCare Shady Grove Medical Center

location_facility: MidMichigan Medical Center Midland Main Center

location_facility: Cardiovascular Research Of Northwest Indiana, Llc

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Horizon Research Group of Opelousas, LLC

location_facility: Ponce Medical School Foundation Inc Centro Med Episcopal San Lucas

location_facility: Cardiovascular Institute of the South Dept of Cardiovascular Inst

location_facility: University Hospitals Cleveland Medical Center Univ. Hospitals of Cleveland

location_facility: North Memorial Heart and Vascular Institute


title: A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

summary:
This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).

The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

ReferenceCitation: Cheminant M, Lhermitte L, Bruneau J, Sicard H, Bonnafous C, Touzart A, Bourbon E, Ortonne N, Genestier L, Gaulard P, Palmic P, Suarez F, Frenzel L, Naveau L, Bazarbachi A, Dussiot M, Waast L, Avettand-Fenoel V, Brouzes C, Pique C, Lepelletier Y, Asnafi V, Marçais A, Hermine O. KIR3DL2 contributes to the typing of acute adult T-cell leukemia and is a potential therapeutic target. Blood. 2022 Sep 29;140(13):1522-1532. doi: 10.1182/blood.2022016765.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

type: Registry Identifier

location_country:
Spain
Canada
Puerto Rico
United States
France
Japan

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of California, San Francisco - Liver Clinic

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: University of Florida Hepatology Research at the Clinical and Translational Research Building

location_facility: Indiana University Health Enterprise Clinical Research Operations

location_facility: Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi

location_facility: The Institute for Liver Health DBA Arizona Liver Health

location_facility: University of California, Davis Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: The Institution For Liver Health dba Arizona Liver Health

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)

location_facility: Yale Center for Clinical Investigation, Church Street Research Unit

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: Center for Research at Southwest Gastroenterology Associates, PC

location_facility: Diabetes and Glandular Disease Clinic, P.A.

location_facility: Hospital Universitario y Politecnlo la Fe

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Internal Medicine Digestive and Liver Diseases Clinical Trials

location_facility: Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital

location_facility: Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)

location_facility: Northwell Health Center for Liver Diseases

location_facility: Encore Borland-Groover Clinical Research

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Nice - Hopital L'archet

location_facility: (G.I.R.I.) Gastrointestinal Research Institute

location_facility: Atrium Health Transplant and Center for Liver Disease

location_facility: Wlliam Osler Health System - Brampton Civic Hospital

location_facility: Hospital General Universiatrio Gregorio Maranon

location_facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond

location_facility: Digestive Health Research of Southern California

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: University of California, San Diego - Altman Clinical and Translational Research Institute

location_facility: Keck Medical Center of USC Healthcare Consultation II

location_facility: Schiff Center for Liver Diseases/ University of Miami

location_facility: Toronto Digestive Disease Associates Specialty Research

location_facility: Rush University Medical Group - Department of Hepatology

location_facility: Toronto General Hospital - University Health Network

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Tulane University Health Sciences Center

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Virginia Commonwealth University Health Clinical Research Services Unit

location_facility: Gastrointestinal (GI) Specialists of Georgia

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario La Paz Edificio de Malemidad

location_facility: Clinical Research Institute of Ohio, LLC

location_facility: University of Alabama at Birmingham Hospital

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic

location_facility: Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau

location_facility: Asheville Gastroenterology, a Division of Digestive Health Partners, PA

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Digestive Health Research of North Texas

location_facility: London Health Sciences Centre - University Hospital

location_facility: International Medical Investigational Centers, Inc.

summary: The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated cirrhosis due to NASH.


title: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

summary: The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib or abemaciclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Austria
Australia
Russian Federation
Canada
United Kingdom
Switzerland
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Germany
Bulgaria