title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program

location_country:
Germany
United States
United Kingdom
France

location_facility: 1100.1526.3312A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3307A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3304A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3311A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4914 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3302A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4909 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3306A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4905 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4908 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4911 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3301A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4913 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3308A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3310A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4906 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4915 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1004 Boehringer Ingelheim Investigational Site

summary: The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.


title: A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

summary: This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Artu Biologicals

location_country:
Poland
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: QMC Notthingham, Nottingham University Hospitals NHS Trust

location_facility: Rijnland Ziekenhuis, Location Alphen - Poli KNO

location_facility: Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1

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

location_facility: Royal National Throat, Nose & Ear Hospital

location_facility: SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 3

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


status: Completed

intervention_type: Drug

title: A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Pápai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

location_country:
Spain
Italy
United Kingdom
Venezuela
United States
Romania
Japan
South Africa
Poland
Hong Kong
Austria
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Czech Republic
Thailand
Korea, Republic of
France
Colombia
Netherlands

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

location_facility: Mayo Clinic - Rochester Division of Hematology

location_facility: New York Oncology Hematology, P.C. NYOH Amsterdam

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc

location_facility: University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)

location_facility: Birmingham Hematology and Oncology Associates

location_facility: University of Pennsylvania Medical Center CAMN107G2301

location_facility: New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)

location_facility: University of California at Los Angeles GI Oncology Program

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)

location_facility: Kootenai Medical Center Dept.ofKootenai Med.Ctr.

location_facility: Stanford University Medical Center Stanford Cancer Center

location_facility: City of Hope National Medical Center Regulatory Document

location_facility: Washington Hospital Center Wash Hospital

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)

location_facility: Vanderbilt Univeristy Ingram Cancer Ctr.

location_facility: Ocala Oncology Center Dept. of Ocala Oncology Center

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: Northwestern University Clinical Research Office (2)

location_facility: University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)

summary: This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

status_simplified: Completed


title: Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)

lead_sponsor: Boehringer Ingelheim

location_country:
Portugal
Spain
United Kingdom
Austria
Australia
Netherlands
Argentina
Canada
Czech Republic
Switzerland
Korea, Republic of
United States
France
Romania
Germany

location_facility: 1220.5.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3309A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3504 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4912 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0008 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6105 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3507 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4917 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8211 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6108 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8208 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3506 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4915 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3307A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6107 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6110 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4910 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6109 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8210 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3308A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4907 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0010 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4903 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8209 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4303 Boehringer Ingelheim Investigational Site

summary: The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.


type: Other Identifier

title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

summary: A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

ReferenceCitation: Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.

ReferenceCitation: Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572.

lead_sponsor: Centocor, Inc.

location_country:
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
New Zealand
United States
France
Israel
Belgium
Germany


title: ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)

acronym: ARTEMIS-IPF

summary: The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

status: Terminated

ReferenceType: result

ReferenceCitation: Raghu G, Behr J, Brown KK, Egan JJ, Kawut SM, Flaherty KR, Martinez FJ, Nathan SD, Wells AU, Collard HR, Costabel U, Richeldi L, de Andrade J, Khalil N, Morrison LD, Lederer DJ, Shao L, Li X, Pedersen PS, Montgomery AB, Chien JW, O'Riordan TG; ARTEMIS-IPF Investigators*. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial. Ann Intern Med. 2013 May 7;158(9):641-9. doi: 10.7326/0003-4819-158-9-201305070-00003. Erratum in: Ann Intern Med. 2014 May 6;160(9):658.

ReferenceCitation: Raghu G, Lynch D, Godwin JD, Webb R, Colby TV, Leslie KO, Behr J, Brown KK, Egan JJ, Flaherty KR, Martinez FJ, Wells AU, Shao L, Zhou H, Pedersen PS, Sood R, Montgomery AB, O'Riordan TG. Diagnosis of idiopathic pulmonary fibrosis with high-resolution CT in patients with little or no radiological evidence of honeycombing: secondary analysis of a randomised, controlled trial. Lancet Respir Med. 2014 Apr;2(4):277-84. doi: 10.1016/S2213-2600(14)70011-6. Epub 2014 Feb 18.

ReferenceCitation: Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.

lead_sponsor: Gilead Sciences

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Poland
Austria
Australia
Argentina
Israel
Mexico
Brazil
Canada
Switzerland
Germany
Ireland
Czech Republic
France
Chile
Colombia
Netherlands

location_facility: University of Miami Miller School of Medicine

location_facility: University of Alabama at Birmingham Hospital

location_facility: National Jewish Medical And Research Center

location_facility: Pulmonary And Critical Care Services, P.C.

location_facility: Complejo Asistencial Universitario de León

location_facility: University of Pennsylvania Health Systems

location_facility: David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)


ipd_sharing: Yes

status: Active, not recruiting

acronym: Canopy-A

title: A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)

study_start_date_type: Actual

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

This trial data will be available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Iceland
Japan
Philippines
Romania
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Russian Federation
Argentina
India
Israel
Panama
Turkey
Norway
Malaysia
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Jordan
Greece
Georgia
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia

location_facility: VA Palo Alto Health Care System CRLX030A2301

location_facility: Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology

location_facility: Advanced Medical Specialties Drug Ship - 2

location_facility: Rush University Medical Center CLDT600AUS06

location_facility: Louis Stokes Cleveland Department of Veterans Affairs MC

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)

location_facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

location_facility: Virginia Cancer Specialists Fairfax Northern Virginia

summary: The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

status_simplified: Ongoing


status: Recruiting

title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

lead_sponsor: Celgene

type: Registry Identifier

ReferenceCitation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Oct 5;122:106958. doi: 10.1016/j.cct.2022.106958. [Epub ahead of print]

enrollment_type: Anticipated

location_country:
Croatia
Saudi Arabia
Italy
Spain
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Norway
Bosnia and Herzegovina
Canada
Switzerland
Germany
Bulgaria
Moldova, Republic of
Denmark
Taiwan
Belarus
Ireland
Latvia
Finland
Korea, Republic of
France
Chile

location_facility: Washington University School of Medicine

location_facility: Integrated University Hospital Santa Maria della Misericordia of Udine

location_facility: Samara Station Railway Clinical Hospital under OAO Russian Railways

location_facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

location_facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

location_facility: Queen Fabiola Children's University Hospital

location_facility: Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Korea University Medical Center - Korea University Ansan Hospital

location_facility: Cleveland Clinic - Taussig Cancer Institute

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

location_facility: Bucharest University Emergency Hospital, Department of Internal Medicine II

location_facility: P. Stradins Clinical University Hospital

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

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Public City Clinical Hospital of Emergency Medical Care

location_facility: "Sfanta Treime" Clinical Municipal Hospital

location_facility: Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: Sart Tilman Hospital Department of Gastroenterology and Hepatology

location_facility: The Center for Gastrointestinal Disorders

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Hospital Christus Muquerza del Parque S.A. de C.V.

location_facility: Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: General Hospital "Prim.dr. Abdulah Nakas"

location_facility: Bezmialem Foundation University Medical Faculty

location_facility: Washington University School Of Medicine

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: SPb SBIH City Hospital of Saint Martyr Elizaveta

location_facility: Practice for Gastroenterology and Internal Medicine

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Krajská nemocnice Pardubice, Kožní oddelení

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office

location_facility: Ternopil City Public Emergency Medical Care Hospital

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: Harry Perkins Medical Research Institute, Fiona Stanley Hospital

location_facility: Medical Center of Far-Eastern Federal University

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Craiova County Emergency Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Federal Siberian Research and Clinical Center

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Multiprofile Hospital for Active Treatment Medline

location_facility: Targu Mures County Emergency Clinical Hospital

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Humanitas Research Hospital - Humanitas Mirasole S.p.A

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: London Health Sciences Centre, University Hospital

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Kornel Gibinski Independent Public Central Clinical Hospital in Katowice

location_facility: Biopharma Informatic Inc. Research Center

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: Republican Clinical Hospital, Department of Colorectal Surgery

location_facility: ACIBADEM City Clinic Medical Center Bregalnitsa

location_facility: Maternal Pediatric and Adolescent Healthcare Centre

location_facility: University Hospital Centre Zagreb, Clinic of Internal Diseases

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: University Polyclinic Hospital G. Martino

location_facility: University Hospital Germans Trias i Pujol

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: H-T. Medical Center Sp. z o.o. LLC Limited Partnership

location_facility: Centro de Investigacion Clinica Acelerada (CICA) S.C.

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC.

location_facility: Bat Yamon Medical Center, Clalit Medical Services

location_facility: Children's Center for Digestive Healthcare

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Instituto Tecnológico y de Estudios Superiores de Monterrey

location_facility: Provincial Specialist Hospital in Olsztyn

location_facility: Univerisity Polyclinic Foundation Agostino Gemelli

location_facility: Advanced Research for Health Improvement

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Salve Limited Liability Company Limited Partnership, Outpatient Clinic

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Gastroenterology Associates Of Central Georgia LLC

location_facility: Primorsky Regional Clinical Hospital No.1

location_facility: University of Oklahoma Health Sciences Center

location_facility: Center of Diagnosis and Treatment Provita

location_facility: Research Associates of South Florida LLC

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Dr. Carol Davila Central Military Emergency Clinical Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: VA Northern California Health Care System

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

location_facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital

location_facility: Moscow Clinical Scientific and Practical Center

location_facility: Toronto Digestive Disease Associates Inc

location_facility: University of Calgary Health - The Gastrointestinal Research Group (GIRG)

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie

summary: This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.


title: A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.

summary:
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

ReferenceCitation: Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

ReferenceCitation: Richeldi L, Costabel U, Selman M, Kim DS, Hansell DM, Nicholson AG, Brown KK, Flaherty KR, Noble PW, Raghu G, Brun M, Gupta A, Juhel N, Klüglich M, du Bois RM. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011 Sep 22;365(12):1079-87. doi: 10.1056/NEJMoa1103690.

location_country:
Spain
Italy
United Kingdom
South Africa
Belgium
Portugal
Russian Federation
Australia
Argentina
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility: 1199.30.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3304C Boehringer Ingelheim Investigational Site

location_facility: 1199.30.06005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88606 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35107 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35109 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39013 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3301A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88604 Chang Gung Memorial Hosp-Linkou

location_facility: 1199.30.56001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.54002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3303A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35108 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35101 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.06004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35301 Mater Misericordiae Hospital

location_facility: 1199.30.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305C Boehringer Ingelheim Investigational Site

location_facility: 1199.30.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88601 National Taiwan University

location_facility: 1199.30.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88603 Tri-service General Hospital

location_facility: 1199.30.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.30.52001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88605 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61003 Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

acronym: SATURN

summary: The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

ReferenceCitation: Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19.

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Poland
Portugal
Spain
United Kingdom
Austria
Netherlands
Russian Federation
Finland
Czech Republic
Sweden
Hungary
France
Norway
Germany
Slovakia


title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.

summary: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

ReferenceCitation: Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Sweden
Singapore
Canada
Switzerland
Hungary
Germany
Taiwan
Ireland
Korea, Republic of
France
Netherlands


title: A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

summary: This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

ReferenceCitation: Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012 Apr;12(4):281-9. doi: 10.1016/S1473-3099(11)70374-7. Epub 2012 Feb 8.

ReferenceCitation: D'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5.

ReferenceCitation: Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.

ReferenceCitation: Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2:S154-61. doi: 10.1093/cid/cis462.

ReferenceCitation: Figueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2:S104-9. doi: 10.1093/cid/cis357.

lead_sponsor: Optimer Pharmaceuticals LLC

location_country:
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Belgium
Germany


title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine. (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients With Chronic Myeloid. Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

ReferenceCitation: Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.

location_country:
Poland
United Kingdom
Italy
Canada
Hungary
United States
France
India
Singapore
Germany

location_facility:
Teva Investigational Site 303
Teva Investigational Site 324
Teva Investigational Site 320
Teva Investigational Site 310
Teva Investigational Site 325
Teva Investigational Site 311
Teva Investigational Site 302
Teva Investigational Site 305
Teva Investigational Site 309
Teva Investigational Site 329
Teva Investigational Site 380
Teva Investigational Site 328
Teva Investigational Site 361
Teva Investigational Site 308
Teva Investigational Site 331
Teva Investigational Site 370
Teva Investigational Site 360
Teva Investigational Site 323
Teva Investigational Site 371
Teva Investigational Site 330
Teva Investigational Site 390
Teva Investigational Site 340
Teva Investigational Site 314
Teva Investigational Site 322
Teva Investigational Site 327
Teva Investigational Site 350
Teva Investigational Site 321
Teva Investigational Site 313
Teva Investigational Site 301

summary: A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.


title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Latvia
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands

location_facility: Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

location_facility: The Third Xiangya Hospital, Central South University

location_facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

location_facility: Hospital Nuestra Señora de la Misericordia

location_facility: Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital

location_facility: Rajiv Gandhi Institute of Medical Sciences

location_facility: Miller Children's at Long Beach Medical Center

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

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

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Ospedale San Giuseppe - Fatebenefratelli

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Suretech Hospital and Research Centre Limited

location_facility: Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD

location_facility: Hospital de Medicina de São José do Rio Preto

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

location_facility: Centre of Tuberculosis and Lung Diseases

location_facility: Clinical Research Centre University of Cape Town

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

location_facility: Bamrasnaradura Infectious Disease Institute

location_facility: Infectious Diseases Center of Vilnius University Hospital Santaros klinikos

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carità

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

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Fortis Flight Lieutenant Rajan Dhall Hospital

location_facility: Santa Casa de Misericordia de Belo Horizonte

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

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

location_facility: Department for Heart Failure and Valvular Disease

location_facility: Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Health Sciences North Horizon Sante-Nord

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Communal Institution Central City Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Taipei Medical University-Wan Fang Hospital

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio

summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.


title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

acronym: BIO|STREAM HF

summary: The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: No individual participant data in planned to be shared with other researchers

lead_sponsor: Biotronik SE & Co. KG

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Austria
Australia
Latvia
United Kingdom
Switzerland
Hungary
France
Israel
Singapore
South Africa
Belgium
Japan
Germany
Slovakia
Czechia

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

location_facility: The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute

location_facility: Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde

location_facility: Hospital General Universitario de Valencia

location_facility: Maria Heimsuchung - Carita-Klinik Pankow

location_facility: Hospital General Universitario de Alicante

location_facility: Le Centre Hospitalier Universitaire de CAEN

location_facility: Saitama Medical University International Medical Center

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: East-Slovak Cardiology Institute (VUSCH)

location_facility: Centre Hospitalier Bretagne Atlantique Prosper Chubert

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Hôpital Privé / Institute Jaques Cartier

intervention_type: Device


title: Improvement of Outcome in Elderly Patients or Patients Not Eligible for High-dose Chemotherapy With Aggressive NHL in First Relapse/Progression by Adding Nivolumab to Gemcitabine, Oxaliplatin Plus Rituximab in Case of B-cell Lymphoma

acronym: NIVEAU

summary: This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma

lead_sponsor: Universität des Saarlandes

location_country: Poland Portugal Austria Netherlands France Israel Belgium Germany

location_facility: St. Antonius-Hospital Eschweiler, Klinik für Hämatologie

location_facility: Uniklinikum Ulm, Klinik für Innere Medizin III

location_facility: CH Départemental Vendée - Onco-Hématologie

location_facility: CHU de Nantes - Hôtel Dieu - Hématologie

location_facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Hematology

location_facility: Universitätsklinikum Tübingen, Innere Medizin II

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Universitätsmedizin Rostock, Klinik für Hämatologie

location_facility: Charité - Universitätsklinikum Berlin, Med. Klinik m. S. Hämatologie

location_facility: Uni Gießen und Marburg, Klinik für Hämatologie

location_facility: Universitätsmedizin Göttingen, Klinik für Hämatologie

location_facility: Krankenhaus der Barmherzigen Brüder, I. Med. Abteilung

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

location_facility: Marien Kliniken Siegen, Klinik für Hämatologie, Medizinische Onkologie und Palliativmedizin

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin

location_facility: Universitätsklinikum des Saarlandes, Innere Med. I

location_facility: CHU Côte de Nacre - Service Hématologie Clinique

location_facility: BAG Freiberg-Richter, Jacobasch, Wolf, Illmer

location_facility: UNIVERSITE CATHOLIQUE DE LOUVAIN MONT GODINNE - Hematology

location_facility: Marie Sklodowska-Curie Institute and Oncology

location_facility: Klinikum Stuttgart, Klinik für Hämatologie

location_facility: Kepler Universitätsklinikum GmbH- Med. Campus III

location_facility: CHU de Montpellier - Hématologie Clinique

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: Gemeinschaftspraxis Dres. Mohm, Prange-Krex

location_facility: Universitätsklinikum Regensburg, Klinik für Innere Medizin III

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1

location_facility: Ordensklinikum Linz - Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Schwarzwald-Baar Klinikum, Innere Medizin II

location_facility: Hôpital Henri Mondor - Unité "Hémopathies Lymphoïdes" - HDJ 11è

location_facility: Institut de Cancèrologie Lucien Neuwirth

location_facility: Vivantes Klinikum am Urban, Klinik für Innere, Hämatologie und Onkologie

location_facility: UNIVERSITAIR ZIEKENHUIS GENT - Hematology

location_facility: Medizinische Hochschule Hannover, Klinik für Hämatologie

location_facility: Westpfalz-Klinikum, Klinik für Innere Medizin I

location_facility: Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I

location_facility: Universitätsklinikum Haale (Saale), Klinik für Innere Medizin IV

location_facility: Universitätsklinik für Innere Medizin I, AKH Wien

location_facility: St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2

location_facility: The Chaim Sheba Medical Center - Division of Hematology and Bone-Marrow Transplantation

location_facility: CHU de Grenoble - Hôpital Albert Michallon - Hématologie Clinique

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Klinikum der Universität München, Med. Klinik und Poliklinik III

location_facility: CHU Dijon - Hôpital d'Enfants - Hématologie Clinique

location_facility: Instituto Português Oncologia - Hematology

lead_sponsor_type: academique


acronym: RELIEF

title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections

lead_sponsor: Bayer

ReferenceCitation: Gyssens IC, Dryden M, Kujath P, Nathwani D, Schaper N, Hampel B, Reimnitz P, Alder J, Arvis P. A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections. J Antimicrob Chemother. 2011 Nov;66(11):2632-42. doi: 10.1093/jac/dkr344. Epub 2011 Sep 6.

ReferenceCitation: Schaper NC, Dryden M, Kujath P, Nathwani D, Arvis P, Reimnitz P, Alder J, Gyssens IC. Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Infection. 2013 Feb;41(1):175-86. doi: 10.1007/s15010-012-0367-x. Epub 2012 Nov 23.

ReferenceCitation: D'Onofrio V, Monnier AA, Kremer C, Stappers MHT, Netea MG, Gyssens IC. Lesion size is associated with genetic polymorphisms in TLR1, TLR6, and TIRAP genes in patients with major abscesses and diabetic foot infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):353-360. doi: 10.1007/s10096-019-03732-7. Epub 2019 Nov 30.

location_country:
Poland
Romania
Spain
Greece
Austria
Ireland
Italy
Latvia
Lithuania
Netherlands
Russian Federation
Ukraine
Hungary
France
Israel
South Africa
United Kingdom
Belgium
Germany
Bulgaria

summary: Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.


title: Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial

summary: This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

ReferenceCitation: Harter P, Pautier P, Van Nieuwenhuysen E, Reuss A, Redondo A, Lindemann K, Kurzeder C, Petru E, Heitz F, Sehouli J, Degregorio N, Wimberger P, Burges A, Cron N, Ledermann J, Lorusso D, Paoletti X, Marme F. Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer - a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34). Int J Gynecol Cancer. 2020 Dec;30(12):1997-2001. doi: 10.1136/ijgc-2020-001572. Epub 2020 Jun 30.

lead_sponsor: AGO Research GmbH

location_country: Denmark Spain Austria Estonia Finland Lithuania Switzerland Sweden France Belgium Norway Germany

location_facility: Vall d'Hebron Instituto de Oncología (VHIO)

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut Català d'Oncologia (ICO) d'Hospitalet

location_facility: Praxisgemeinschaft Frauenärzte am Bahnhofsplatz

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: Institut Català d'Oncologia (ICO) de Girona

location_facility: Vilniaus universiteto ligoninė Santaros klinikos

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital General Universitario Morales Meseguer

location_facility: IUCT Oncopole - Institut Claudius Regaud

location_facility: SASU Centre d'Oncologie et Radiothérapie 37

location_facility: Blois Hospital (Centre Hospitalier de Blois)

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Charité - Universitätsmedizin Berlin (CVK)

location_facility: Copenhagen University Hospital, Rigshospitalet


title: An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

acronym: SEQUOIA

summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival.

ReferenceCitation: Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26.

ReferenceCitation: Tam CS, Robak T, Ghia P, Kahl BS, Walker P, Janowski W, Simpson D, Shadman M, Ganly PS, Laurenti L, Opat S, Tani M, Ciepluch H, Verner E, Šimkovič M, Österborg A, Trněný M, Tedeschi A, Paik JC, Kuwahara SB, Feng S, Ramakrishnan V, Cohen A, Huang J, Hillmen P, Brown JR. Zanubrutinib monotherapy for patients with treatment naïve chronic lymphocytic leukemia and 17p deletion. Haematologica. 2020 Oct 13;106(9):2354-2363. doi: 10.3324/haematol.2020.259432.

ReferenceCitation: Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, Šimkovič M, Shadman M, Österborg A, Laurenti L, Walker P, Opat S, Chan H, Ciepluch H, Greil R, Tani M, Trněný M, Brander DM, Flinn IW, Grosicki S, Verner E, Tedeschi A, Li J, Tian T, Zhou L, Marimpietri C, Paik JC, Cohen A, Huang J, Robak T, Hillmen P. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5. Epub 2022 Jul 7.

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Spain
Italy
Austria
Australia
New Zealand
Russian Federation
United Kingdom
United States
France
Belgium
Sweden
Czechia

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: City Clinical Hospital No. 52 of the Moscow Healthcare Department

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Centre Hospitalier Universitaire (CHU) de Liège - Site du Sart Tilman

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"

location_facility: Universitätsklinik für Innere Medizin Salzburg

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Presidio Ospedaliero di Gardone Val Trompia

location_facility: Fakultní Nemocnice Hradec Králové - Ústav Klinické Imunologie a Alergologie

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: City Hospitals Sunderland NHS Foundation Trust

location_facility: State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

location_facility: Municipal Healthcare Institution "Clinical Medical Sanitary Establishment #1"

location_facility: Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

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

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii

location_facility: Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph

location_facility: Universita Degli Studi di Modena-Azienda Ospedaliere Policlinco

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A.

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

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

location_facility: Centre Hospitalier Universitaire Limoges CHU de Limoges

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: Centre Hospitalier Victor Dupouy d'Argenteuil

location_facility: Institut Català d'Oncologia - L'Hospitalet de Llobregat


acronym: The REALM Study

title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L. Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B. J Clin Transl Hepatol. 2020 Dec 28;8(4):377-384. doi: 10.14218/JCTH.2020.00039. Epub 2020 Oct 10.

ReferenceCitation: Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.

ReferenceCitation: Hou JL, Jia JD, Wei L, Zhao W, Wang YM, Cheng M, Tang X, Tan DM, Ren H, Tang H, Cohen D, Llamoso C. Efficacy and safety of entecavir treatment in a heterogeneous CHB population from a 'real-world' clinical practice setting in China. J Viral Hepat. 2013 Nov;20(11):811-20.

location_country:
Spain
Italy
United States
Romania
Philippines
Czechia
Poland
Portugal
Russian Federation
Argentina
India
Turkey
Mexico
Singapore
Brazil
Canada
China
Germany
Taiwan
Greece
Thailand
Korea, Republic of
France
Colombia

location_facility: Tulane University Health Sciences Center

location_facility: University Of Miami Center For Liver Diseases

location_facility: Cedars-Sinai Comprehensive Transplant Center

summary: The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.


title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

summary: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

ReferenceCitation: Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12:55. doi: 10.1186/1465-9921-12-55.

lead_sponsor: AstraZeneca

location_country:
Denmark
Poland
Romania
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
Czech Republic
Andorra
Hungary
France
Belgium
Germany
Bulgaria

location_facility:
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acronym: POLARIX

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.

ReferenceCitation: Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trněný M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgués JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Turkey
Brazil
Canada
Switzerland
China
Germany
Taiwan
New Zealand
Korea, Republic of
France

location_facility: University of North Carolina at Chapel Hill

location_facility: Medical University of South Carolina Hospital

location_facility: McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Emory University; Investigational Drug Service

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

location_facility: Univerzita Karlova v Praze 1. Lekarska Fakulta

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Barts Health NHS Trust; Bartholomew's H., King George V Building

location_facility: Hôpital Saint-Louis; Service d'Hématologie

location_facility: CHRU DE STRASBOURG; Département d'Hématologie et Oncologie

location_facility: Roswell Park Cancer Institute; Grace Cancer Drug Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: West Virginia Uni Med. Center - Robert Byrd Health Science

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

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University Hospitals Case Medical Center

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

location_facility: Kobe City Medical Center General Hospital

location_facility: Fox Chase Cancer Center; Hematology/Oncology

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Dana Farber Cancer Institute; Lymphoma Program

location_facility: MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

location_facility: Ronald Reagan UCLA Medical Center; Drug Information Center

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: University of Pittsburgh Medical Center Cancer Center; Pharmacy

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Westmead Hospital; Outpatient Pharmacy University Clinic

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique

location_facility: Northwest Cancer Specialists - Portland (SW Barnes Rd)

location_facility: Universitätsspital Basel Gynäkologie - Onkologie

location_facility: Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang

location_facility: Wiener Gesundheitsverbund - Klinik Ottakring

location_facility: National Cancer Center; Medical Oncology

location_facility: CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich w Chorzowie

location_facility: Hirslanden Medical Center - Tumorzentrum

location_facility: China Medical University Hospital; Clinical Research Center Clinical Pharmacy

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: SPZOZ Ministerstwa Spraw Wewnętrznych i Administracji w Poznaniu; Oddział Hematologii

location_facility: Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

location_facility: Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III

location_facility: Levine Cancer Institute - Clincal Trials Administration

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: Shanghai East Hospital, Tongji University

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: CH Bretagne Atlantique; Médecine interne

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Canterbury Health Laboratories; Immunology/Rheumatology

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Khmelnytskyi Regional Hospital; Department of Hemathology

location_facility: Oncology Associates of Southwest Virginia, Inc.

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)

location_facility: Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika

location_facility: Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Gh Necker Enfants Malades; Hematologie Clinique

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Pôle de Cancérologie - CHU de Saint-Etienne'

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis

location_facility: Kaohsiung Medical University Hospital, Cancer Center

location_facility: L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: University of Louisville Hospital; The James Graham Brown Cancer Center

location_facility: Pusan National University Yangsan Hospital; hemato-oncology

location_facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w Łodzi

location_facility: Texas Oncology San Antonio Medical Center

summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).


title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)

acronym: SILVER

summary:
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

ReferenceCitation: Montgomery SA, Locklear JC, Svedsäter H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.

ReferenceCitation: Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.

ReferenceCitation: Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.

location_country:
Denmark
Romania
Spain
Argentina
Czech Republic
Canada
Finland
Sweden
France
South Africa
Mexico
Norway
Germany
Bulgaria
Slovakia


title: A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

summary: This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

design_allocation: Non-Randomized

ReferenceCitation: Agarwal N, McGregor B, Maughan BL, Dorff TB, Kelly W, Fang B, McKay RR, Singh P, Pagliaro L, Dreicer R, Srinivas S, Loriot Y, Vaishampayan U, Goel S, Curran D, Panneerselvam A, Schwickart M, Choueiri TK, Pal S. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). Lancet Oncol. 2022 Jul;23(7):899-909. doi: 10.1016/S1470-2045(22)00278-9. Epub 2022 Jun 9.

ReferenceCitation: Pal SK, McGregor B, Suárez C, Tsao CK, Kelly W, Vaishampayan U, Pagliaro L, Maughan BL, Loriot Y, Castellano D, Srinivas S, McKay RR, Dreicer R, Hutson T, Dubey S, Werneke S, Panneerselvam A, Curran D, Scheffold C, Choueiri TK, Agarwal N. Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study. J Clin Oncol. 2021 Nov 20;39(33):3725-3736. doi: 10.1200/JCO.21.00939. Epub 2021 Sep 7.

ipd_sharing: Undecided

lead_sponsor: Exelixis

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
United States
France
Belgium
Germany

location_facility:
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