title: A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer

summary: This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.

status: Unknown status

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

name: All authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

family: Wedam

full_name: Suparna B. Wedam

given: Suparna B.

family: Beaver

full_name: Julia A. Beaver

given: Julia A.

family: Amiri-Kordestani

full_name: Laleh Amiri-Kordestani

given: Laleh

family: Bloomquist

full_name: Erik Bloomquist

given: Erik

family: Tang

full_name: Shenghui Tang

given: Shenghui

family: Goldberg

full_name: Kirsten B. Goldberg

given: Kirsten B.

family: Sridhara

full_name: Rajeshwari Sridhara

given: Rajeshwari

family: Ibrahim

full_name: Amna Ibrahim

given: Amna

family: Kim

full_name: Geoffrey Kim

given: Geoffrey

family: Kluetz

full_name: Paul Kluetz

given: Paul

family: McKee

full_name: Amy McKee

given: Amy

family: Pazdur

full_name: Richard Pazdur

given: Richard

publisher_group: American Society of Clinical Oncology (ASCO)

location_country:
Peru
Guatemala
Greece
Australia
Russian Federation
Taiwan
Ukraine
Uruguay
France
Panama
Norway
Canada
Korea, Republic of
Sweden
Netherlands
Philippines
Singapore
United States
United Kingdom
Brazil
Mexico
Spain


type: EudraCT Number

title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

acronym: RE-ALIGN

summary: To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

sequence: first

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

sequence: additional

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Kappetein

full_name: Arie P. Kappetein

given: Arie P.

family: Mack

full_name: Michael J. Mack

given: Michael J.

family: Blatchford

full_name: Jon Blatchford

given: Jon

family: Devenny

full_name: Kevin Devenny

given: Kevin

family: Friedman

full_name: Jeffrey Friedman

given: Jeffrey

family: Guiver

full_name: Kelly Guiver

given: Kelly

family: Harper

full_name: Ruth Harper

given: Ruth

family: Khder

full_name: Yasser Khder

given: Yasser

family: Lobmeyer

full_name: Maximilian T. Lobmeyer

given: Maximilian T.

family: Maas

full_name: Hugo Maas

given: Hugo

family: Voigt

full_name: Jens-Uwe Voigt

given: Jens-Uwe

family: Simoons

full_name: Maarten L. Simoons

given: Maarten L.

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Dabigatran versus Warfarin in Patients with Mechanical Heart Valves

lead_sponsor: Boehringer Ingelheim

location_country:
Sweden
Netherlands
Germany
France
Poland
Norway
Belgium
Denmark
Canada
Czech Republic

location_facility: 1160.113.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11007 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32007 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11006 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.46003 Skånes Universitetssjukhus Lund

location_facility: 1160.113.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49008 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49010 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11011 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32005 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11009 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.

summary: The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.

status: Completed

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, Schechter M, Peeters M, Picchio G, Vingerhoets J, Woodfall B, De Smedt G; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009 Nov 13;23(17):2289-300. doi: 10.1097/QAD.0b013e3283316a5e.

family: Katlama

full_name: Christine Katlama

given: Christine

family: Haubrich

full_name: Richard Haubrich

given: Richard

family: Lalezari

full_name: Jacob Lalezari

given: Jacob

family: Lazzarin

full_name: Adriano Lazzarin

given: Adriano

family: Madruga

full_name: José V Madruga

given: José V

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Schechter

full_name: Mauro Schechter

given: Mauro

family: Peeters

full_name: Monika Peeters

given: Monika

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Vingerhoets

full_name: Johan Vingerhoets

given: Johan

family: Woodfall

full_name: Brian Woodfall

given: Brian

family: De Smedt

full_name: Goedele De Smedt

given: Goedele

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Kakuda TN, Wade JR, Snoeck E, Vis P, Schöller-Gyüre M, Peeters MP, Corbett C, Nijs S, Vingerhoets J, Leopold L, De Smedt G, Woodfall BJ, Hoetelmans RM. Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients. Clin Pharmacol Ther. 2010 Nov;88(5):695-703. doi: 10.1038/clpt.2010.181. Epub 2010 Sep 29.

family: Kakuda

full_name: T N Kakuda

given: T N

family: Wade

full_name: J R Wade

given: J R

family: Snoeck

full_name: E Snoeck

given: E

family: Vis

full_name: P Vis

given: P

family: Schöller-Gyüre

full_name: M Schöller-Gyüre

given: M

full_name: M P Peeters

given: M P

family: Corbett

full_name: C Corbett

given: C

family: Nijs

full_name: S Nijs

given: S

full_name: J Vingerhoets

given: J

title: Pharmacokinetics and Pharmacodynamics of the Non-Nucleoside Reverse-Transcriptase Inhibitor Etravirine in Treatment-Experienced HIV-1-Infected Patients

ReferenceCitation: Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010 Nov;65(11):2450-4. doi: 10.1093/jac/dkq332. Epub 2010 Aug 27.

ReferenceCitation: Vingerhoets J, Azijn H, Tambuyzer L, Dierynck I, De Meyer S, Rimsky L, Nijs S, De Smedt G, de Béthune MP, Picchio G. Short communication: activity of etravirine on different HIV type 1 subtypes: in vitro susceptibility in treatment-naive patients and week 48 pooled DUET study data. AIDS Res Hum Retroviruses. 2010 Jun;26(6):621-4. doi: 10.1089/aid.2009.0239.

title: Short Communication: Activity of Etravirine on Different HIV Type 1 Subtypes: In Vitro Susceptibility in Treatment-Naive Patients and Week 48 Pooled DUET Study Data

ReferenceCitation: Madruga JV, Cahn P, Grinsztejn B, Haubrich R, Lalezari J, Mills A, Pialoux G, Wilkin T, Peeters M, Vingerhoets J, de Smedt G, Leopold L, Trefiglio R, Woodfall B; DUET-1 study group. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007 Jul 7;370(9581):29-38.

location_country:
Brazil
Chile
Costa Rica
Mexico
France
Panama
Thailand
Argentina
Puerto Rico
United States


title: An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients

summary:
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.

Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.

Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.

278 study subjects were enrolled at 28 transplant centers in the United States and Europe.

ReferenceCitation: Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77.

ReferenceCitation: Lentine KL, Schnitzler MA, Xiao H, Brennan DC. Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants. Trials. 2015 Aug 19;16:365. doi: 10.1186/s13063-015-0891-y. Erratum in: Trials. 2015;16:412.

family: Lentine

full_name: Krista L. Lentine

given: Krista L.

family: Schnitzler

full_name: Mark A. Schnitzler

given: Mark A.

family: Xiao

full_name: Huiling Xiao

given: Huiling

family: Brennan

full_name: Daniel C. Brennan

given: Daniel C.

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: Washington University School of Medicine - Digital Commons@Becker

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
France
Spain
Germany
United Kingdom

location_facility: Florida Hospital Medical Center and Translife

status_simplified: Completed


type: Other Identifier

title: A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

summary: The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Rutgeerts

full_name: Paul Rutgeerts

given: Paul

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Olson

full_name: Allan Olson

given: Allan

family: Johanns

full_name: Jewel Johanns

given: Jewel

family: Lu

full_name: Jiandong Lu

given: Jiandong

family: Horgan

full_name: Kevin Horgan

given: Kevin

family: Rachmilewitz

full_name: Daniel Rachmilewitz

given: Daniel

family: Hanauer

full_name: Stephen B. Hanauer

given: Stephen B.

family: Lichtenstein

full_name: Gary R. Lichtenstein

given: Gary R.

family: de Villiers

full_name: Willem J.S. de Villiers

given: Willem J.S.

family: Present

full_name: Daniel Present

family: Sands

full_name: Bruce E. Sands

given: Bruce E.

family: Colombel

full_name: Jean Frédéric Colombel

given: Jean Frédéric

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Colectomy Rate Comparison After Treatment of Ulcerative Colitis With Placebo or Infliximab

lead_sponsor: Janssen Research & Development, LLC

location_country:
Austria
Switzerland
Netherlands
Germany
France
Czechia
Israel
Argentina
Australia
Belgium
New Zealand
Denmark
United States
United Kingdom
Canada


title: An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma

summary: This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Hong Kong
Netherlands
France
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State

location_facility: Memorial Sloan Kettering Cancer Center MSK 2

location_facility: Hackensack University Medical Center Hackensack (SC)

location_facility: University of Texas/MD Anderson Cancer Center SC Location

location_facility: Washington University School of Medicine Div. of Medical Oncology


title: A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

summary: The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

ReferenceCitation: Marks WH, Mamode N, Montgomery RA, Stegall MD, Ratner LE, Cornell LD, Rowshani AT, Colvin RB, Dain B, Boice JA, Glotz D; C10-001 Study Group. Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial. Am J Transplant. 2019 Oct;19(10):2876-2888. doi: 10.1111/ajt.15364. Epub 2019 Apr 19.

name: Formerly Alexion Pharmaceuticals Boston Massachusetts

name: Independent Consultant Bellevue Washington

family: Marks

full_name: William H. Marks

given: William H.

name: Department of Transplant Surgery Guy's and St Thomas’ Evelina London Children's and Great Ormond Street Hospitals NHS Trust London UK

family: Mamode

full_name: Nizam Mamode

given: Nizam

name: NYU Langone Transplant Institute New York University Langone Medical Center New York New York

family: Montgomery

full_name: Robert A. Montgomery

given: Robert A.

name: The William J. von Liebig Center for Transplantation and Clinical Regeneration and Division of Transplantation Surgery Department of Surgery Mayo Clinic Rochester Minnesota

family: Stegall

full_name: Mark D. Stegall

given: Mark D.

name: Department of Surgery Columbia University New York New York

family: Ratner

full_name: Lloyd E. Ratner

given: Lloyd E.

name: Department of Laboratory Medicine and Pathology Mayo Clinic Rochester Minnesota

family: Cornell

full_name: Lynn D. Cornell

given: Lynn D.

name: Department of Internal Medicine Section of Nephrology and Transplantation Erasmus MCUniversity Medical Center Rotterdam Rotterdam The Netherlands

family: Rowshani

full_name: Ajda T. Rowshani

given: Ajda T.

name: Department of Pathology Harvard Medical School Massachusetts General Hospital Boston Massachusetts

family: Colvin

full_name: Robert B. Colvin

given: Robert B.

name: Independent statistics consultantGuilford Connecticut

family: Dain

full_name: Bradley Dain

given: Bradley

family: Boice

full_name: Judith A. Boice

given: Judith A.

name: Paris Translational Research Center for Organ Transplantation Institut National de la Santé et de la Recherche MédicaleUnité Mixte de Recherche‐S970 Paris France

name: Department of Nephrology and Organ Transplantation Saint‐Louis HospitalAssistance Publique‐Hôpitaux de ParisInstitut National de la Santé et de la Recherche MédicaleUnité U1160 Paris France

family: Glotz

full_name: Denis Glotz

given: Denis

family: Kanellis

full_name: John Kanellis

given: John

family: Russ

full_name: Graeme Russ

given: Graeme

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: Lebranchu

full_name: Yvon Lebranchu

given: Yvon

family: Legendre

full_name: Christophe Legendre

given: Christophe

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Hugo

full_name: Christian Hugo

given: Christian

family: Colussi

full_name: Giacomo Colussi

given: Giacomo

family: Rigotti

full_name: Paolo Rigotti

given: Paolo

family: Reisaeter

full_name: Anna Reisaeter

given: Anna

family: Oppenheimer

full_name: Frederic Oppenheimer

given: Frederic

family: Mjörnstedt

full_name: Lars Mjörnstedt

title: Safety and efficacy of eculizumab in the prevention of antibody‐mediated rejection in living‐donor kidney transplant recipients requiring desensitization therapy: A randomized trial

location_country:
Italy
United States
Sweden
Netherlands
France
Norway
Australia
Spain
Germany
United Kingdom


ReferenceCitation: Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27.

name: Pfizer Global Research and Development, Groton, CT, USA

family: Antinew

full_name: Jeremias Antinew

given: Jeremias

name: Pfizer Global Product Development Group, Paris, France

family: Pitrosky

full_name: Bruno Pitrosky

given: Bruno

family: Knapp

full_name: Lloyd Knapp

given: Lloyd

family: Almas

full_name: Mary Almas

given: Mary

family: Pitman

full_name: Verne Pitman

given: Verne

family: Liu

full_name: Jing Liu

given: Jing

name: Pediatric Neurology Discipline, Neurosciences Department, Carol Davila University of Medicine, Bucharest, Romania

family: Craiu

full_name: Dana Craiu

given: Dana

name: Department of Pediatrics, Perpetual Succour Hospital, Cebu City, Philippines

family: Modequillo

full_name: Margaret Modequillo

given: Margaret

name: Neuroscience Institute at Children’s Hospital Los Angeles, Los Angeles, CA, USA

family: Nordli

full_name: Douglas Nordli

given: Douglas

name: First Department of Pediatrics, Semmelweis University, Budapest, Hungary

family: Farkas

full_name: Viktor Farkas

given: Viktor

full_name: Mark Kristof Farkas

given: Mark Kristof

journal_name: Journal of Child Neurology

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

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

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
Serbia
Philippines
France
Czechia
Bulgaria
Greece
Israel
Malaysia
Hungary
Belgium
Poland
Romania
Singapore
Turkey
United States
Korea, Republic of
Ukraine

acronym: PERIWINKLE

location_facility: Center for Neurodiagnostic and Therapeutic Services

location_facility: Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,

location_facility: Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria",

location_facility: Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology

location_facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",

location_facility: Spitalul clinic de copii Dr. Victor Gomoiu

location_facility: Centre Hospitalier Neurologique William Lennox

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

location_facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

location_facility: Ege University Medical Faculty Department of Pediatrics Health and Diseases

location_facility: NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fakultni nemocnice Brno - Detska nemocnice

location_facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly

location_facility: Katedra i Klinika Neurologii Wieku Rozwojowego

location_facility: Center for Clinical and Translational Science

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia

location_facility: Dr. Kenessey Albert Korhaz es Rendelointezet

location_facility: Duke Children's Hospital and Health Center

location_facility: Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: University of Kentucky Hospital Epilepsy Monitoring Unit

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

location_facility: General Childrens Hospital of Athens P & A Kyriakou

location_facility: UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania

location_facility: Cliniques Universitaires de Bruxelles Hôpital Erasme

location_facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

location_facility: Behcet Uz Children Disease and surgery Training and research hospital

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

location_facility: Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak

location_facility: Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi

location_facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,

location_facility: University of Kentucky Hospital Pharmacy, UK Chandler Hosptial

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

ipd_sharing: Yes

source: euctr

title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

summary: Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.


title: A Trial Comparing the Efficacy and Safety of Adding Liraglutide Versus Addition of Insulin Aspart With the Largest Meal to Insulin Degludec, Both in Combination With Metformin, in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification (BEGIN™: VICTOZA® ADD-ON)

acronym: BEGIN™

summary:
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

ReferenceCitation: Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Ocampo Francisco AM, Rana A, Zinman B; BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jul;16(7):636-44. doi: 10.1111/dom.12262. Epub 2014 Feb 11.

name: UZ Leuven University of Leuven Leuven Belgium

family: Mathieu

full_name: C. Mathieu

given: C.

name: Endocrine and Metabolic Consultants Rockville MD USA

family: Rodbard

full_name: H. W. Rodbard

given: H. W.

name: Clinique d'Endocrinologie, l'Institut du Thorax CHU Nantes Nantes France

family: Cariou

full_name: B. Cariou

given: B.

name: Metabolic Institute of America Tarzana CA USA

family: Handelsman

full_name: Y. Handelsman

given: Y.

name: Scripps Whittier Diabetes Institute La Jolla CA USA

family: Philis‐Tsimikas

full_name: A. Philis‐Tsimikas

given: A.

family: Ocampo Francisco

full_name: A. M. Ocampo Francisco

given: A. M.

name: Novo Nordisk Canada, Inc. Mississauga Canada

family: Rana

full_name: A. Rana

name: Lunenfeld‐Tanenbaum Research Institute, Mount Sinai Hospital University of Toronto Toronto Canada

family: Zinman

full_name: B. Zinman

name: on behalf of the BEGIN: VICTOZA ADD‐ON (NN1250‐3948) study group

journal_name: Diabetes, Obesity and Metabolism

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes ( BEGIN : VICTOZA ADD‐ON )

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
United States
Serbia
Germany
Finland
France
Norway
Belgium
Spain
Denmark
Canada
Czech Republic


title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy

summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

ReferenceCitation: Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9.

family: Coleman

full_name: R. Coleman

given: R.

family: de Boer

full_name: R. de Boer

family: Eidtmann

full_name: H. Eidtmann

given: H.

family: Llombart

full_name: A. Llombart

family: Davidson

full_name: N. Davidson

given: N.

family: Neven

full_name: P. Neven

given: P.

family: von Minckwitz

full_name: G. von Minckwitz

given: G.

family: Sleeboom

full_name: H.P. Sleeboom

family: Forbes

full_name: J. Forbes

given: J.

family: Barrios

full_name: C. Barrios

family: Frassoldati

full_name: A. Frassoldati

family: Campbell

full_name: I. Campbell

given: I.

family: Paija

full_name: O. Paija

given: O.

family: Martin

full_name: N. Martin

family: Modi

full_name: A. Modi

family: Bundred

full_name: N. Bundred

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
Peru
Guatemala
Finland
Belgium
Australia
Czech Republic
Taiwan
Spain
France
Thailand
Argentina
Korea, Republic of
Colombia
Chile
Hong Kong
Netherlands
Philippines
Switzerland
China
Portugal
Germany
United Kingdom
Italy
Brazil
Mexico
Venezuela
Egypt
New Zealand

location_facility:
Ratchathew
Novartis Investigative Site


title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

journal_name: Respiratory Research

repository_institution: University of Dundee - Discovery Research Portal

ReferenceCitation: Hohlfeld JM, Furtwaengler A, Könen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.

name: Fraunhofer Institute for Toxicology and Experimental Medicine Hannover Germany

family: Hohlfeld

full_name: J. M. Hohlfeld

given: J. M.

name: Boehringer Ingelheim Pharma GmbH & Co. K.G. Ingelheim Germany

family: Furtwaengler

full_name: A. Furtwaengler

family: Könen‐Bergmann

full_name: M. Könen‐Bergmann

given: M.

family: Wallenstein

full_name: G. Wallenstein

name: Independent Consultant Limburgerhof Germany

family: Walter

full_name: B. Walter

name: Division of Pulmonology Department of Medicine University of Cape Town Cape Town South Africa

family: Bateman

full_name: E. D. Bateman

given: E. D.

journal_name: International Journal of Clinical Practice

oa_colors: green hybrid

title: Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter‐ECG data from four randomised clinical trials

ReferenceCitation: Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

location_country:
United States
Sweden
Netherlands
Germany
France
Greece
Norway
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom

location_facility: Boehringer Ingelheim Investigational Site


title: An Exploratory, Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Study, for the Assessment of Efficacy, Safety and Tolerability of Ucb 34714 50 mg Oral Capsules in b.i.d. Administration at the Doses of 200 mg/Day and 400 mg/Day, in Subjects (at Least 18 Years Old) Suffering From Post Herpetic Neuralgia (PHN)

summary: Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

lead_sponsor: UCB Pharma

location_country:
Serbia
France
Czechia
Bulgaria
Poland
Slovakia
Belgium
Spain
Germany
United Kingdom


title: A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions

acronym: ZoMaxx™ I

summary: The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.

ReferenceCitation: Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus- versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries The ZoMaxx I trial. JACC Cardiovasc Interv. 2008 Oct;1(5):524-32. doi: 10.1016/j.jcin.2008.08.010.

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Di Mario

full_name: Carlo Di Mario

given: Carlo

family: Neumann

full_name: Franz-Josef Neumann

given: Franz-Josef

family: Ribichini

full_name: Flavio Ribichini

given: Flavio

family: Urban

full_name: Philip Urban

given: Philip

family: Popma

full_name: Jeffrey J. Popma

given: Jeffrey J.

family: Fitzgerald

full_name: Peter J. Fitzgerald

given: Peter J.

family: Cutlip

full_name: Donald E. Cutlip

given: Donald E.

family: Williams

full_name: David O. Williams

given: David O.

family: Ormiston

full_name: John Ormiston

given: John

family: Grube

full_name: Eberhard Grube

given: Eberhard

family: Whitbourn

full_name: Robert Whitbourn

given: Robert

family: Schwartz

full_name: Lewis B. Schwartz

given: Lewis B.

journal_name: JACC: Cardiovascular Interventions

title: A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Zotarolimus- Versus Paclitaxel-Eluting Stents in De Novo Occlusive Lesions in Coronary Arteries

lead_sponsor: Abbott Medical Devices

location_country:
Switzerland
Netherlands
France
Belgium
Australia
New Zealand
Portugal
Denmark
Germany
United Kingdom

location_facility: Cardiology Practice and Hospital Prof. Silber

location_facility: Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux

location_facility: Rigshospitalet / University of Copenhagen

intervention_type: Device


title: A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

acronym: SEPIA-PCI

summary: The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.

lead_sponsor: Sanofi

location_country:
United States
South Africa
Netherlands
Germany
France
Slovakia
Belgium
Spain
Canada
Czech Republic

location_facility: University of Pennsylvania Health System

location_facility: Klinikum der Friedrich-Schiller-Universitat Jena

location_facility: Cardiac Catheterization Laboratories of the CHUM

location_facility: Middle Slovak Institute of Cardiovascular Diseases

location_facility: University of Oklahoma Health Sciences Center

location_facility: George Washington University Medical Faculty Associates

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Isala Klinleken, Hospital De Weezenlanden

location_facility: University of Oklahoma Health Science Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Klinik der Universitat Munchen-Grobhadern

location_facility: Klinikum Schwalmstadt der Schwalm-Eder-Kliniken

location_facility: Universitatsklinikum Hamburg - Eppendorf

location_facility: Sunnybrook and Women's College Health Sciences Centre

location_facility: Center Hospitalier Universitaire Jean-Minjoz

location_facility: Amarillo Heart Clinical Research Institute Inc

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

intervention_type: Procedure


title: A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023

summary: The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

enrollment_type: Anticipated

ReferenceCitation: Adams DH, Zhang L, Millen BA, Kinon BJ, Gomez JC. Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison. Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 Mar 19.

name: Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA

family: Adams

full_name: David H. Adams

given: David H.

family: Zhang

full_name: Lu Zhang

given: Lu

family: Millen

full_name: Brian A. Millen

given: Brian A.

family: Kinon

full_name: Bruce J. Kinon

given: Bruce J.

family: Gomez

full_name: Juan-Carlos Gomez

given: Juan-Carlos

currency_apc_doaj: USD

journal_name: Schizophrenia Research and Treatment

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

lead_sponsor: Eli Lilly and Company

location_country:
Austria
Sweden
Germany
France
Poland
Romania
Belgium
Puerto Rico
Spain
United States

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


title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

acronym: FAST

summary:
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.

The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.

ReferenceCitation: Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

family: Hsia

full_name: Cyrus C. Hsia

given: Cyrus C.

family: Chin-Yee

full_name: Ian H. Chin-Yee

given: Ian H.

family: McAlister

full_name: Vivian C. McAlister

given: Vivian C.

journal_name: Annals of Surgery

title: Use of Recombinant Activated Factor VII in Patients Without Hemophilia

ReferenceCitation: Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534.

family: Mayer

full_name: Stephan A. Mayer

given: Stephan A.

family: Brun

full_name: Nikolai C. Brun

given: Nikolai C.

family: Begtrup

full_name: Kamilla Begtrup

given: Kamilla

family: Broderick

full_name: Joseph Broderick

given: Joseph

family: Davis

full_name: Stephen Davis

given: Stephen

family: Diringer

full_name: Michael N. Diringer

given: Michael N.

family: Skolnick

full_name: Brett E. Skolnick

given: Brett E.

family: Steiner

full_name: Thorsten Steiner

given: Thorsten

oa_host_type: repository

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

title: Efficacy and Safety of Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
Croatia
France
Thailand
Norway
Canada
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
China
Germany
United States
Italy
Austria
Brazil
Israel
Spain


title: A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse

summary:
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.

ReferenceCitation: Giles F, Vey N, DeAngelo D, Seiter K, Stock W, Stuart R, Boskovic D, Pigneux A, Tallman M, Brandwein J, Kell J, Robak T, Staib P, Thomas X, Cahill A, Albitar M, O'Brien S. Phase 3 randomized, placebo-controlled, double-blind study of high-dose continuous infusion cytarabine alone or with laromustine (VNP40101M) in patients with acute myeloid leukemia in first relapse. Blood. 2009 Nov 5;114(19):4027-33. doi: 10.1182/blood-2009-06-229351. Epub 2009 Aug 26.

name: Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center, San Antonio;

family: Giles

full_name: Francis Giles

given: Francis

name: Institut Paoli Calmettes, Marseille, France;

family: Vey

full_name: Norbert Vey

given: Norbert

name: Dana-Farber Cancer Institute, Boston, MA;

family: DeAngelo

full_name: Daniel DeAngelo

given: Daniel

family: Seiter

full_name: Karen Seiter

given: Karen

family: Stock

full_name: Wendy Stock

given: Wendy

name: Medical University of South Carolina (MUSC) Hollings Cancer Center, Charleston;

family: Stuart

full_name: Robert Stuart

given: Robert

name: Clinical Center of Serbia, Belgrade, Serbia;

family: Boskovic

full_name: Darinka Boskovic

given: Darinka

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

name: Robert H. Lurie Comprehensive Cancer Center, Chicago, IL;

family: Tallman

full_name: Martin Tallman

given: Martin

name: Princess Margaret Hospital, Toronto, ON;

family: Brandwein

full_name: Joseph Brandwein

name: University Hospital of Wales, Cardiff, United Kingdom;

family: Kell

full_name: Jonathan Kell

given: Jonathan

name: Medical University of Lodz, Lodz, Poland;

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

name: Klinikum der Universität Köln, Köln, Germany;

family: Staib

full_name: Peter Staib

given: Peter

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Cahill

full_name: Ann Cahill

given: Ann

name: Quest Diagnostics Nichols Institute, San Juan Capistrano, CA; and

family: Albitar

full_name: Maher Albitar

given: Maher

name: University of Texas (UT) M. D. Anderson Cancer Center, Houston

family: O'Brien

full_name: Susan O'Brien

given: Susan

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Giles FJ, Stock W, Vey N, et al.: A double blind placebo-controlled randomized phase III study of high dose continuous infusion cytosine arabinoside (araC) with or without cloretazine in patients with first relapse of acute myeloid leukemia (AML). [Abstract] Blood 108 (11): A-1970, 2006.

lead_sponsor: Vion Pharmaceuticals

location_country:
United States
Serbia
Netherlands
Germany
France
Poland
Greece
Belgium
Canada
United Kingdom

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Hollings Cancer Center at Medical University of South Carolina

location_facility: American Health Network - North Meridian

location_facility: Jonsson Comprehensive Cancer Center at UCLA

location_facility: Penn State Cancer Institute at Milton S. Hershey Medical Center

location_facility: USC/Norris Comprehensive Cancer Center and Hospital

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Riverside Methodist Hospital Cancer Care

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

location_facility: Vancouver Hospital and Health Science Center

location_facility: Veterans Affairs Medical Center - Tampa (Haley)

location_facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University

location_facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

location_facility: Brody School of Medicine at East Carolina University

location_facility: Institute of Haematology and Blood Transfusion

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

location_facility: Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

location_facility: University of Chicago Cancer Research Center

location_facility: Greenebaum Cancer Center at University of Maryland Medical Center

location_facility: Capital District Health Authority Center for Clinical Research

location_facility: Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

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

intervention_type: Other


title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women

summary: The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.

ReferenceCitation: Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol. 2009 Jun 1;27(16):2630-7. doi: 10.1200/JCO.2008.18.8391. Epub 2009 Apr 20.

name: From the Vall d'Hebron University Hospital, Barcelona; Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain; NN Petrov Research Institute of Oncology; and City Oncological Dispensary, St Petersburg, Russian Federation; Onc Centrum St Augustinus, Wilrijk, Belgium; Centre Rene Gauducheau, Nantes, France; Department of Special Gynecology, Medical University of Vienna/Austria; University Hospital, Salzburg, Austria; Istituto Nazionale Tumori, Milan, Italy; Novartis Pharma AG, Basel, Switzerland;...

family: Baselga

full_name: José Baselga

given: José

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

family: van Dam

full_name: Peter van Dam

family: Manikhas

full_name: Alexey Manikhas

given: Alexey

family: Bellet

full_name: Meritxell Bellet

given: Meritxell

family: Mayordomo

full_name: José Mayordomo

family: Campone

full_name: Mario Campone

given: Mario

family: Kubista

full_name: Ernst Kubista

given: Ernst

family: Greil

full_name: Richard Greil

given: Richard

family: Bianchi

full_name: Giulia Bianchi

given: Giulia

family: Steinseifer

full_name: Jutta Steinseifer

given: Jutta

family: Molloy

full_name: Betty Molloy

given: Betty

family: Tokaji

full_name: Erika Tokaji

given: Erika

family: Gardner

full_name: Humphrey Gardner

given: Humphrey

family: Phillips

full_name: Penny Phillips

given: Penny

family: Stumm

full_name: Michael Stumm

given: Michael

family: Lane

full_name: Heidi A. Lane

given: Heidi A.

family: Dixon

full_name: J. Michael Dixon

given: J. Michael

family: Jonat

full_name: Walter Jonat

given: Walter

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II Randomized Study of Neoadjuvant Everolimus Plus Letrozole Compared With Placebo Plus Letrozole in Patients With Estrogen Receptor–Positive Breast Cancer

location_country:
Italy
Austria
United States
Germany
France
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Investigative Clinical Research of Indiana


title: A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium

summary: The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Sweden
Switzerland
Philippines
France
Thailand
Greece
Singapore
Australia
Spain
Indonesia
Canada
Korea, Republic of

location_facility:
Local Insitution
Local Institution


title: Irbesartan Versus Placebo in Combination With Standard Cardiovascular Protection ACE-I Therapy With Ramipril for the Treatment of Albuminuria in Hypertensive Subjects at Elevated Cardiovascular Risk

summary: Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.

ReferenceCitation: Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. Epub 2007 Aug 1.

location_country:
Italy
United States
United Kingdom
Mexico
Netherlands
Germany
France
Lithuania
Israel
Australia
Russian Federation
Spain
Canada
Latvia


title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

summary: The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Italy
United States
Spain
France
Poland
Israel
Argentina
Australia
Puerto Rico
Russian Federation
Canada
United Kingdom

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: City Hospital of Infectious Diseases #10

location_facility: Liver Unit, Royal Infirmary of Edinburgh

location_facility: Hopital Saint Joseph Service d'Hépato-gastroentérologie

location_facility: Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej

location_facility: Department of infectious diseases, Russian Military Academy

location_facility: University of Massachusetts Memorial Medical Center

location_facility: CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie

location_facility: Saint Louis University School of Medicine

location_facility: Az. Osp. Universitaria Policlinico "Paolo Giaccone"

location_facility: Malattie Infettive, Azienda Ospedaliera di Busto Arsizio

location_facility: Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM

location_facility: City Hospital of Infectious Diseases #30

location_facility: Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: University of California Davis Medical Center

location_facility: Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology

location_facility: University of Colorado Health Sciences Center

location_facility: Hospital General Universitario de Valencia

location_facility: Head of Liver Unit, Holy family Hospital

location_facility: Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista

location_facility: Keck School of Medicine, University of Southern California

location_facility: Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza

location_facility: Liver and Hepatobiliary Unit, Queen Elizabeth Hospital

location_facility: C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie

location_facility: Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie

location_facility: Louisiana State University Memorial Hospital

location_facility: Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie


title: Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-centre Study to Assess ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)

summary: This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).

ReferenceCitation: James ND, Caty A, Borre M, Zonnenberg BA, Beuzeboc P, Morris T, Phung D, Dawson NA. Safety and efficacy of the specific endothelin-A receptor antagonist ZD4054 in patients with hormone-resistant prostate cancer and bone metastases who were pain free or mildly symptomatic: a double-blind, placebo-controlled, randomised, phase 2 trial. Eur Urol. 2009 May;55(5):1112-23. doi: 10.1016/j.eururo.2008.11.002. Epub 2008 Nov 29.

family: James

full_name: Nicholas D. James

given: Nicholas D.

family: Caty

full_name: Armelle Caty

given: Armelle

family: Borre

full_name: Michael Borre

family: Zonnenberg

full_name: Bernard A. Zonnenberg

given: Bernard A.

family: Beuzeboc

full_name: Philippe Beuzeboc

given: Philippe

family: Morris

full_name: Thomas Morris

given: Thomas

family: Phung

full_name: De Phung

given: De

family: Dawson

full_name: Nancy A. Dawson

given: Nancy A.

journal_name: European Urology

title: Safety and Efficacy of the Specific Endothelin-A Receptor Antagonist ZD4054 in Patients with Hormone-Resistant Prostate Cancer and Bone Metastases Who Were Pain Free or Mildly Symptomatic: A Double-Blind, Placebo-Controlled, Randomised, Phase 2 Trial

lead_sponsor: AstraZeneca

location_country:
United States
Sweden
Switzerland
Netherlands
Finland
Indonesia
France
Poland
Norway
Belgium
Australia
Denmark
Canada
United Kingdom

location_facility:
Research site
Research Site


title: A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

acronym: SABRE

summary: The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

location_country:
South Africa
Netherlands
France
Greece
Spain
United States
United Kingdom
Canada


title: A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

summary: This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.

lead_sponsor: Pfizer

location_country:
Belgium
United States
Australia
France


title: A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

summary: The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

location_country:
Italy
Austria
Peru
Mexico
Spain
Germany
France
Greece
Argentina
Australia
Belgium
Puerto Rico
United States
Colombia


title: An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer

summary: The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
France
Poland
Lithuania
Thailand
Canada
South Africa
Switzerland
Netherlands
Philippines
Singapore
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Israel
New Zealand
Spain
Turkey
Latvia


title: See Detailed Description

summary: A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

ReferenceCitation: EFFICACY AND SAFETY OF A ONCE DAILY FIXED-DOSE COMBINATION OF ABACAVIR/LAMIVUDINE (ABC/3TC) [FDC ] VERSUS ABC TWICE DAILY AND 3TC ONCE DAILY AS SEPARATE ENTITIES [SE] IN ART-EXPERIENCED HIV-1 INFECTED SUBJECTS (CAL30001): 48 WEEK DATA. Clumeck, N., LaMarca, A., Fu, K., Gordon, D., Craig, C., Zhao, H. , Paes, D., and Scott, T. (WePe6.3C13), 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro; Brazil, 7/24/2005

ReferenceCitation: C Craig, C Stone, T Bonny, K Fu. Similar virology findings in ABC/3TC fixed dose combination (FDC) OAD compared with standard dosing in experienced subjects (CAL30001, ALTO). 7th ICDTHI, Glasgow, UK, 14-18 November 2004. Abstract 98

ReferenceCitation: Clumeck N, Lamarca A, Fu K, Gordon D, Craig C, Zhao H, Paes D, Scott T. Safety and efficacy of a once daily (OAD) Fixed-Dose Combination (FDC) of ABC/3TC [FDC arm] versus ABC twice daily (BID) and 3TC OAD as separate entities [SE arm] in ART-Experienced HIV-1 Infected Patients. 44th ICAAC, Washington, DC, 30 October-2 November 2004. Abstr. H-558

lead_sponsor: ViiV Healthcare

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


title: A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

summary: Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

ReferenceCitation: Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. Epub 2006 Aug 14.

ReferenceCitation: Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4.

lead_sponsor: Bayer

location_country:
Italy
France
Israel
Belgium
United States


title: A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)

summary: This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

location_country:
Italy
Brazil
Chile
Peru
Mexico
Netherlands
Spain
France
Belgium
Argentina
Australia
Puerto Rico
United States
United Kingdom
Canada

location_facility: Univ of South Carolina School of Medicine

location_facility: Hospital de Clinicas da Universidade Federal do Parana

location_facility: North Texas Center for AIDS & Clinical Research

location_facility: Montreal Gen Hosp / Div of Clin Immuno and Allergy

location_facility: Hosp de Basurto / Enfermedades Infecciosas

location_facility: Department of Infection & Tropical Medicine

location_facility: Infectious Diseases Associates of Houston

location_facility: San Francisco Veterans Administration Med Ctr

location_facility: North Jersey Community Research Initiative

location_facility: Infectious Disease Specialists of Atlanta


title: A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 With Efavirenz; Each in Combination With Fixed Dose Zidovudine-Lamivudine

summary: The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).

location_country:
Peru
Guatemala
Malaysia
Belgium
Russian Federation
Costa Rica
France
Panama
Thailand
Canada
South Africa
Chile
Switzerland
Hungary
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
Venezuela
Israel
Spain

location_facility: Univ of Alberta/Division of Inf Dis/Dept of Med

location_facility: Hosp Roosevelt Chief Infectious Diseases Unit

location_facility: Servicio de Dermatologia-Hosp del Salvador

location_facility: Saint Josephs Comprehensive Research Institute

location_facility: Rheinische Friedrich Wilhelms Universitaet Medizinische

location_facility: North Broward Hosp District / HIV Clinical Research

location_facility: Univ of Michigan Hospitals and Health Ctrs

location_facility: Hosp Clinico de La Pontificia Universidad Catolica de Chile

location_facility: Tarrant County Infectious Diseases Associates

location_facility: Duke Univ Med Ctr / Infectious Disease Clinic


title: The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy

summary: The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

location_country:
Italy
Brazil
South Africa
Mexico
Spain
France
Thailand
Israel
Belgium
Argentina
Australia
Portugal
Puerto Rico
Russian Federation
United States
Canada

location_facility: Federal University of Minas, Dept. of Pediatrics

location_facility: Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab

location_facility: Instituto Nacional de Enfermedades Respiratorias


title: Phase II Trial With ISIS 3521/CGP 64128A in Patients With Malignant Melanoma and Non Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ISIS 3521 in treating patients who have advanced, unresectable, or metastatic non-small cell lung cancer or unresectable or metastatic melanoma.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Austria
Switzerland
Netherlands
France
Norway
Belgium
Denmark
Germany
United Kingdom

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Ludwig Institute for Cancer Research-Brussels Branch

location_facility: Universitaetsklinik und Strahlenklinik - Essen

intervention_type: Biological


title: Phase I Study of KRN7000 in Patients With Solid Tumor Treated With a Weekly Intravenous Administration Schedule

summary:
RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment.

status: Withdrawn


title: Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes

summary:
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have primary myelodysplastic syndrome.


title: Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every Week for 3 Consecutive Weeks, Followed by One Week's Rest

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors.


title: Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of E7070 in treating patients who have solid tumors.


title: Phase I and Pharmacokinetics Study to Determine the Safety of BIBX 1382 in Patients With a Solid Tumor on a Continuous Daily Oral Administration Schedule and After Single Oral and Intravenous Doses

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BIBX 1382 in treating patients who have solid tumors.

status: Suspended


title: Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks


title: TENDyne European expeRience Registry

acronym: TENDER

summary: TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: LMU Klinikum

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

location_facility:
UKE Hamburg
Universitaetsklinikum Koeln
Universitätsmedizin Mainz
University hospital Oslo
Herz- und Diabeteszentrum NRW
Universitaetsklinikum Bonn
University Hospital of Vigo
Hospital Clinico Valladolid
CHU de Bordeaux
Clinique Pasteur
University Hospital of Pisa
UZ Leuven
Inselspital Bern
Universitaetsklinikum Tuebingen
Deutsches Herzzentrum Berlin
CHU de Lille
University hospital Madrid
Herzentrum Leipzig
Robert-Bosch-Krankenhaus Stuttgart
Puerto de Hierro Madrid
ICH - Istituto Clinico Humanitas
Universitätsklinikum Frankfurt
Universitaetsklinikum Wien
DHZ München
Universitaetsspital Basel
Royal Brompton London
Universitaetsklinikum Linz
CHU Rennes
Karolinska University Stockholm
Universitaetsklinikum Regensburg

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.

summary: The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

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:
Italy
United States
Switzerland
France
Japan
Belgium
Spain
Turkey
Germany
United Kingdom


title: An Open-Label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of RO7227166 (a CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Belgium
Australia
Spain
Denmark
United Kingdom

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

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia


ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Italy
Netherlands
France
Czechia
Ireland
Belgium
Germany
United Kingdom

acronym: PETITE

title: A Multicenter, Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Neonates With Repeated Electroencephalographic Seizures

summary: The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the optimal BRV dose (Exploratory Cohort) for the treatment of subjects enrolled into the Confirmatory Cohorts of this study.


title: Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury - (NOSTRA Phase III Trial): A Confirmatory, Placebo-controlled, Randomised, Double Blind, Multi-centre Study

acronym: NOSTRA-III

summary: This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome in patients with moderate and severe traumatic brain injury. Half of the participants will receive Ronopterin (VAS203), while the other half will receive placebo.

ReferenceType: background

ReferenceCitation: Stover JF, Belli A, Boret H, Bulters D, Sahuquillo J, Schmutzhard E, Zavala E, Ungerstedt U, Schinzel R, Tegtmeier F; NOSTRA Investigators. Nitric oxide synthase inhibition with the antipterin VAS203 improves outcome in moderate and severe traumatic brain injury: a placebo-controlled randomized Phase IIa trial (NOSTRA). J Neurotrauma. 2014 Oct 1;31(19):1599-606. doi: 10.1089/neu.2014.3344. Epub 2014 Jul 28.

name: University Hospital Zuerich, Zuerich, Switzerland.

family: Stover

full_name: John F. Stover

given: John F.

name: University Hospital Southampton, Southampton, United Kingdom.

family: Belli

full_name: Antonio Belli

given: Antonio

family: Boret

full_name: Henry Boret

given: Henry

family: Bulters

full_name: Diederik Bulters

given: Diederik

name: Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.

family: Sahuquillo

full_name: Juan Sahuquillo

given: Juan

family: Schmutzhard

full_name: Erich Schmutzhard

given: Erich

name: Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain.

family: Zavala

full_name: Elisabeth Zavala

given: Elisabeth

name: Karolinska Institutet, Stockholm, Sweden.

family: Ungerstedt

full_name: Urban Ungerstedt

given: Urban

family: Schinzel

full_name: Reinhard Schinzel

given: Reinhard

family: Tegtmeier

full_name: Frank Tegtmeier

given: Frank

journal_name: Journal of Neurotrauma

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Nitric Oxide Synthase Inhibition with the Antipterin VAS203 Improves Outcome in Moderate and Severe Traumatic Brain Injury: A Placebo-Controlled Randomized Phase IIa Trial (NOSTRA)

ReferenceCitation: Tegtmeier F, Schinzel R, Beer R, Bulters D, LeFrant JY, Sahuquillo J, Unterberg A, Andrews P, Belli A, Ibanez J, Lagares A, Mokry M, Willschke H, Flüh C, Schmutzhard E; NOSTRA Investigators. Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study. Trials. 2020 Jan 14;21(1):80. doi: 10.1186/s13063-019-3965-4. Erratum in: Trials. 2020 Feb 12;21(1):172.

family: Beer

full_name: Ronny Beer

given: Ronny

family: LeFrant

full_name: Jean-Yves LeFrant

given: Jean-Yves

full_name: Joan Sahuquillo

given: Joan

family: Unterberg

full_name: Andreas Unterberg

given: Andreas

family: Andrews

full_name: Peter Andrews

given: Peter

family: Ibanez

full_name: Javier Ibanez

given: Javier

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

location_country:
Austria
France
Spain
Germany
United Kingdom

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Neurochirurgie

location_facility: Universitätsklinikum Jena Klinik und Poliklinik für Neurochirurgie

location_facility: Berufsgenossenschaftliche Kliniken Bergmannsheil Klinik für Neurochirurgie

location_facility: Southampton University Hospital Division of Clinical Neurosciences

location_facility: Klinik für Allgemeine Anästhesie und Intensivmedizin AKH Wien

location_facility: Allgemeines Krankenhaus Celle Neurotraumatologie

location_facility: Vall d'Hebron University Hospital Department of Neurosurgery

location_facility: Hôpital Pellegrin Service de réanimation traumatologique et chirurgicale

location_facility: Neurologie und Neurochirurgie Medizinische Universität Innsbruck

location_facility: Universitätsklinikum Göttingen Klinik für Neurochirurgie

location_facility: Universitätsklinikum Düsseldorf Neurochirurgische Klinik

location_facility: Universitätsklinikum Schleswig-Holstein Klinik für Neurochirurgie

location_facility: Klinik für Neurochirurgie Universität Frankfurt

location_facility: Berufsgenossenschaftliche Kliniken Bergmannstrost Halle Klinik für Neurochirurgie

location_facility: Medizinische Hochschule Hannover Klinik für Neurochirurgie

location_facility: Universitätsklinikum Leipzig Klinik und Poliklinik für Neurochirurgie

location_facility: Pôle Anesthésie Réanimation Douleur Urgence


title: A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome

summary: The aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with Down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.

location_country:
United States
France
Spain

location_facility: CHU de Bordeaux Hopital Pellegrin; Service de Genetique Medicale

location_facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social

location_facility: CHU de Saint Etienne; Service de Génétique

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

location_facility: IMIM, Human Pharmacology and Clinical Neurosciences,


title: Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries

summary: The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

lead_sponsor: Stryker Neurovascular

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust

location_facility: Karolinska University Hospital in Solna, Department of Neuroradiology


title: SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

acronym: SPECTAlung

summary: SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

location_country:
Italy
Switzerland
United Kingdom
France
Poland
Belgium
Spain
Slovenia

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Royal Marsden Hospital - Kingston Hospital

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Royal Marsden Hospital - Chelsea, London

intervention_type: Genetic


title: Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

summary:
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.

This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

time_perspective: Retrospective

lead_sponsor: SuperSonic Imagine

location_country:
Italy
Hong Kong
France
Greece
Romania
Belgium
China
Denmark
Germany

location_facility: Chinese University of Hong Kong - Prince of Wales Hospital


title: A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors

summary: This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.

primary_purpose: Other

location_country:
United Kingdom
Belgium
France


ReferenceCitation: Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcón S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.

ReferenceCitation: Amoroso L, Castel V, Bisogno G, Casanova M, Marquez-Vega C, Chisholm JC, Doz F, Moreno L, Ruggiero A, Gerber NU, Fagioli F, Hingorani P, Melcón SG, Slepetis R, Chen N, le Bruchec Y, Simcock M, Vassal G. Phase II results from a phase I/II study to assess the safety and efficacy of weekly nab-paclitaxel in paediatric patients with recurrent or refractory solid tumours: A collaboration with the European Innovative Therapies for Children with Cancer Network. Eur J Cancer. 2020 Aug;135:89-97. doi: 10.1016/j.ejca.2020.04.031. Epub 2020 Jun 15.

family: Amoroso

full_name: Loredana Amoroso

given: Loredana

family: Castel

full_name: Victoria Castel

given: Victoria

family: Bisogno

full_name: Gianni Bisogno

given: Gianni

family: Casanova

full_name: Michela Casanova

given: Michela

family: Marquez-Vega

full_name: Catalina Marquez-Vega

given: Catalina

family: Chisholm

full_name: Julia C. Chisholm

given: Julia C.

family: Doz

full_name: François Doz

given: François

family: Moreno

full_name: Lucas Moreno

given: Lucas

family: Ruggiero

full_name: Antonio Ruggiero

family: Gerber

full_name: Nicolas U. Gerber

given: Nicolas U.

family: Fagioli

full_name: Franca Fagioli

given: Franca

family: Hingorani

full_name: Pooja Hingorani

given: Pooja

family: Melcón

full_name: Soledad G. Melcón

given: Soledad G.

family: Slepetis

full_name: Ruta Slepetis

given: Ruta

family: Chen

full_name: Nianhang Chen

given: Nianhang

family: le Bruchec

full_name: Yvan le Bruchec

given: Yvan

family: Simcock

full_name: Mathew Simcock

given: Mathew

family: Vassal

full_name: Gilles Vassal

given: Gilles

journal_name: European Journal of Cancer

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

location_country:
Italy
Switzerland
France
Spain
United States
United Kingdom
Canada

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

location_facility: Unidad de Oncologia Pediatrica, Hospital Universitario la Fe

location_facility: l'Azienda Ospedaliera Regina Margherita - Sant Anna

title: A Phase 1/2, Multicenter, Open-label, Dose-finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors.

summary: The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumors.


title: Non-Interventional Study Among Users Of LoFric Origo

summary:
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale

Secondary objectives:

To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale
To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale
To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes.

Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users.

Medical Device: LoFric Origo

Study Variable(s):

Primary variable: Use or No use of LoFric Origo after 8 weeks.
Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.

lead_sponsor: Wellspect HealthCare

location_country:
Switzerland
Netherlands
France
Norway
Belgium
United Kingdom

location_facility: Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman

location_facility: Hôpital Henry Gabrielle, Unité A1 - Service de Rééducation Périnéale et Sexologique

location_facility: Akershus Universitetssykehus HF Urologisk poliklinikk

location_facility: Stavanger Universitetssjukehus, Urologisk poliklinikk

location_facility: University Hospitals Coventry and Warwickshire NHS Trust Walsgrave Hospital

location_facility: National Hospital for Neurology and Neurosurgery Queens Square

location_facility: Centre de Traumatologie et de Readaptation

location_facility: Oslo Universitetssykehus HF - Rikshospitalet Urologisk poliklinikk

location_facility: Hôpital Raymond Poincaré, Service de Neuro-Urologie, Urologie et Sexologie

location_facility: Groupe Urologique de la Clinique Saint Augustin, Cabinet de Neuro-Urologie

location_facility: Hôpital Tenon, Service de Neuro-Urologie et Explorations Périnéales

location_facility: Sunnaas Sykehus HF Urodynamisk laboratorium


title: A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)

acronym: TOSCA

summary: Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

primary_purpose: Basic Science

ReferenceCitation: Stüve O, Cataldi F, Pradhan V, Gorelick KJ. Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post-lumbar puncture headache. J Neuroimmunol. 2017 Sep 15;310:69-71. doi: 10.1016/j.jneuroim.2017.06.011. Epub 2017 Jun 30.

family: Stüve

full_name: Olaf Stüve

given: Olaf

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Pradhan

full_name: Vivek Pradhan

given: Vivek

family: Gorelick

full_name: Kenneth J. Gorelick

given: Kenneth J.

journal_name: Journal of Neuroimmunology

title: Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post–lumbar puncture headache

lead_sponsor: Shire

location_country: Austria Netherlands France Belgium Germany

location_facility: Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und

location_facility: Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum,


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)

summary: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Italy
United States
Serbia
Germany
France
Czechia
Bulgaria
Israel
Poland
Hungary
Australia
Spain
Canada
Ukraine

location_facility:
Coral Springs, Florida
Columbus, Ohio
Zaporiizhzhya
Kirkland, Washington
Cleveland, Ohio
Berlin
Las Vegas, Nevada
Cassino
Saint Louis, Missouri
Ottawa, Ontario
Rychnov nad Kněžnou
Stadtroda
Kogarah, New South Wales
Muenchen
Las Vegas, Nevada,
Creteil,
Hallandale Beach, Florida
Englewood, Colorado
Boulevard Pinel, Bron
Lublin
Toronto, Ontario
Lexington, Kentucky
Madrid
Elche
Kharkiv
Atlantis, Florida
Ancona
San Sebastián
Fountain Valley, California
Winter Park, Florida
Gyor,
Scarborough, Maine
Muenster
Kiev
Spokane, Washington
Kansas
Chocen
Asheville, North Carolina
Prague 5, Czech Republic
Strasbourg
Petah Tiqva
Los Angeles, California
Round Rock, Texas
Budapest
Zaporozhya
Vinnitsa
Belgrade,
Siemianowice Slaskie
Terrassa
Erina, New South Wales
Bochum
Gera
Pisa
Nîmes cedex
Frenso, California
Georgetown, Texas
Toledo, Ohio
Valencia
Port Charlotte, Florida
Warsaw
Torino
Haag in Oberbayern
Szeged
Elk Grove Village, Illinois
West Bloomfield, Michigan
Ocala, Florida
Nantes CEDEX 1
Lubbock, Texas
Tel Aviv
Denver, Colorado
Memphis, Tennessee
Prague
Chicago, Illinois
Krakow
Richmond, Virginia
Katowice
Lodz
Long beach, California
Farmington Hills, Mitchigan
Shoham
Syracuse, New York
Duesseldorf,
Adventura, Florida
Augusta, Georgia
Belgrade
Woolloongabba, Queensland
Pheonix, Arizona
Kragujevac
Ashkelon
Pamplona
Dayton, Ohio
Haifa
Houston, Texas
Jerusalem
Cincinnati, Ohio
Barcelona
Maitland, Florida
Virginia Beach, Virginia
Dnipro
Tampa, Florida
Sofia
Parkville, Victoria
Milano
Rome
Little Rock, Arkansas
Pasadena, California
Boca Raton, Florida
Reseda, California
Sevilla
Rozzano Milano
Kraków
Burlington, Vermont
Pecs
Clayton VIC
Lviv