type: U.S. NIH Grant/Contract

title: A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

summary: This randomized phase III trial studies how well gemcitabine hydrochloride and docetaxel followed by doxorubicin hydrochloride work compared to observation in treating patients with high-risk uterine leiomyosarcoma previously removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination therapy after surgery is an effective treatment for uterine leiomyosarcoma.

lead_sponsor: Gynecologic Oncology Group

sponsor_collaborators:
Gynecologic Oncology Group
National Cancer Institute (NCI)

location_country:
Norway
United Kingdom
Venezuela
Netherlands
Belgium
United States
Spain
France

location_facility: Sutter Solano Medical Center/Cancer Center

location_facility: Medical Oncology and Hematology Associates-Des Moines

location_facility: Saint Luke's Mountain States Tumor Institute - Nampa

location_facility: Harrison HealthPartners Hematology and Oncology-Bremerton

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Lake Norman Hematology Oncology Specialists-Mooresville

location_facility: Columbus NCI Community Oncology Research Program

location_facility: Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

location_facility: Greenville Health System Cancer Institute-Easley

location_facility: Franciscan Saint Anthony Health-Michigan City

location_facility: Southwest Gynecologic Oncology Associates Inc

location_facility: Saint James Community Hospital and Cancer Treatment Center

location_facility: Northwest NCI Community Oncology Research Program

location_facility: Medical Oncology and Hematology Associates-West Des Moines

location_facility: Geisinger Wyoming Valley/Henry Cancer Center

location_facility: University of Iowa/Holden Comprehensive Cancer Center

location_facility: Kaiser Permanente Medical Center-Vacaville

location_facility: Tacoma/Valley Radiation Oncology Centers-Gig Harbor

location_facility: Medical Oncology and Hematology Associates-Laurel

location_facility: MD Anderson Cancer Center at Cooper-Voorhees

location_facility: Pulmonary Medicine Center of Chattanooga-Hixson

location_facility: Wichita NCI Community Oncology Research Program

location_facility: Providence Regional Cancer System-Aberdeen

location_facility: Central Illinois Hematology Oncology Center

location_facility: The Toledo Hospital/Toledo Children's Hospital

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Saint Luke's University Hospital-Bethlehem Campus

location_facility: California Pacific Medical Center-Pacific Campus

location_facility: Kaiser Permanente-Deer Valley Medical Center

location_facility: Kansas City NCI Community Oncology Research Program

location_facility: CHI Saint Vincent Cancer Center Hot Springs

location_facility: Alegent Health Bergan Mercy Medical Center

location_facility: Providence Oncology and Hematology Care Southeast

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: Memorial Sloan Kettering Rockville Centre

location_facility: Swedish Cancer Institute-Eastside Oncology Hematology

location_facility: Providence Saint Joseph Medical Center/Disney Family Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Medical Oncology Hematology Consultants PA

location_facility: Novant Health Cancer Specialists-Matthews

location_facility: Palo Alto Medical Foundation Health Care

location_facility: Sutter Cancer Centers Radiation Oncology Services-Auburn

location_facility: Saint Luke's Mountain States Tumor Institute - Meridian

location_facility: UPMC Cancer Centers - Arnold Palmer Pavilion

location_facility: Rocky Mountain Cancer Centers-Greenwood Village

location_facility: Jewish Hospital Medical Center Northeast

location_facility: Southern Illinois University School of Medicine

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: Harrison HealthPartners Hematology and Oncology-Poulsbo

location_facility: Toledo Clinic Cancer Centers-Bowling Green

location_facility: UH Seidman Cancer Center at Lake Health Mentor Campus

location_facility: Florida Hospital Cancer Institute Winter Park

location_facility: Toledo Community Hospital Oncology Program CCOP

location_facility: New York-Presbyterian/Brooklyn Methodist Hospital

location_facility: Sutter Cancer Centers Radiation Oncology Services-Vacaville

location_facility: UPMC Washington Hospital Radiation Oncology

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Jackson Hall

location_facility: Wilcox Memorial Hospital and Kauai Medical Clinic

location_facility: Virginia Mason Federal Way Medical Center

location_facility: Northeast Georgia Medical Center-Gainesville

location_facility: Sutter Cancer Centers Radiation Oncology Services-Cameron Park

location_facility: Florida Hospital Cancer Institute Altamonte

location_facility: Western Illinois Cancer Treatment Center

location_facility: Geisinger Medical Center-Cancer Center Hazleton

location_facility: Cancer Center of Kansas-Wichita Medical Arts Tower

location_facility: University of Maryland/Greenebaum Cancer Center

location_facility: UPMC Uniontown Hospital Radiation Oncology

location_facility: Greenville Health System Cancer Institute-Eastside

location_facility: Providence Regional Cancer System-Shelton

location_facility: Oklahoma Cancer Specialists and Research Institute-Tulsa

location_facility: Saint Luke's Mountain States Tumor Institute - Fruitland

location_facility: Legacy Good Samaritan Hospital and Medical Center

location_facility: University of Cincinnati/Barrett Cancer Center

location_facility: Providence Regional Cancer System-Centralia

location_facility: Kapiolani Medical Center for Women and Children

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: UT Southwestern/Simmons Cancer Center-Dallas

location_facility: Christiana Care Health System-Wilmington Hospital

location_facility: State University of New York Upstate Medical University

location_facility: UPMC-Heritage Valley Health System Beaver

location_facility: Anchorage Associates in Radiation Medicine

location_facility: University Hospitals Sharon Health Center

location_facility: Delaware Health Center-Grady Cancer Center

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: Saint Vincent Hospital and Health Care Center

location_facility: Saint Joseph Radiation Oncology Resource Center

location_facility: Mercy Clinic-Rolla-Cancer and Hematology

location_facility: Zuckerberg San Francisco General Hospital

location_facility: Tacoma/Valley Radiation Oncology Centers-Saint Joe's

location_facility: Dayton NCI Community Oncology Research Program

location_facility: Greenville Health System Cancer Institute-Greer

location_facility: Armstrong Center for Medicine and Health

location_facility: Missouri Baptist Outpatient Center-Sunset Hills

location_facility: Sudarshan K Sharma MD Limited-Gynecologic Oncology

location_facility: Dayton Physicians LLC-Miami Valley South

location_facility: Palo Alto Medical Foundation-Gynecologic Oncology

location_facility: Greenville Health System Cancer Institute-Seneca

location_facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

location_facility: Presbyterian - Saint Lukes Medical Center - Health One

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: UPMC-Coraopolis/Heritage Valley Radiation Oncology

location_facility: Saint Luke's Mountain States Tumor Institute

location_facility: Providence Willamette Falls Medical Center

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: Delaware Clinical and Laboratory Physicians PA

location_facility: Memorial Health University Medical Center

location_facility: Saint Patrick Hospital - Community Hospital

location_facility: Rockwood Cancer Treatment Center-DHEC-Downtown

location_facility: Saint Louis Cancer and Breast Institute-South City

location_facility: Columbus Oncology and Hematology Associates Inc

location_facility: UC Comprehensive Cancer Center at Silver Cross

location_facility: Saint Luke's Mountain States Tumor Institute-Twin Falls

location_facility: Rockwood Clinic Cancer Treatment Center-Valley

location_facility: Summa Akron City Hospital/Cooper Cancer Center

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: Kansas Institute of Medicine Cancer and Blood Center

location_facility: Wayne State University/Karmanos Cancer Institute

location_facility: Cancer Care Specialists of Illinois - Decatur

location_facility: Dayton Physician LLC-Miami Valley Hospital North

location_facility: Franciscan Research Center-Northwest Medical Plaza

location_facility: UPMC-Johnstown/John P. Murtha Regional Cancer Center

location_facility: OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

location_facility: UH Seidman Cancer Center at Landerbrook Health Center

location_facility: Maine Medical Center- Scarborough Campus

location_facility: Cancer Care Specialists of Illinois-Swansea

location_facility: Sainte Genevieve County Memorial Hospital

location_facility: Memorial Regional Cancer Center Day Road

location_facility: Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

location_facility: Providence Saint Mary Regional Cancer Center

location_facility: Olive View-University of California Los Angeles Medical Center

location_facility: Palo Alto Medical Foundation-Camino Division

location_facility: Lake Norman Hematology Oncology Specialists-Huntersville

location_facility: Novant Health Presbyterian Medical Center

location_facility: Walter Reed National Military Medical Center

location_facility: Greenville Health System Cancer Institute-Andrews

location_facility: Benefis Healthcare- Sletten Cancer Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: Greenville Health System Cancer Institute-Butternut

location_facility: UPMC Jefferson Regional Radiation Oncology

location_facility: OSF Saint Francis Radiation Oncology at Peoria Cancer Center

location_facility: Cooper Hospital University Medical Center

location_facility: Alta Bates Summit Medical Center-Herrick Campus

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: Comprehensive Cancer Care and Research Institute of Colorado LLC

location_facility: Heartland Hematology and Oncology Associates Incorporated

location_facility: Genesis Healthcare System Cancer Care Center

location_facility: Greenville Health System Cancer Institute-Faris

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Greenville Health System Cancer Institute-Spartanburg

location_facility: McFarland Clinic PC-Trinity Cancer Center

location_facility: Atrium Medical Center-Middletown Regional Hospital

location_facility: Iowa-Wide Oncology Research Coalition NCORP

location_facility: Virginia Mason Bainbridge Island Medical Center

location_facility: Tacoma/Valley Radiation Oncology Centers-Puyallup

location_facility: Sutter Cancer Centers Radiation Oncology Services-Roseville

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Cone Health Cancer Center at Alamance Regional


title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Genentech, Inc.

location_country:
Germany
France
Italy
United Kingdom
Argentina
United States
Latvia
Spain
Israel

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

summary:
Primary Objective:

- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

To assess the effect of the 2 lixisenatide regimens on:

The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
Fasting Plasma Glucose (FPG)
7-point Self-Monitored Plasma Glucose (SMPG) profiles
Body weight
To assess the safety and tolerability of the 2 lixisenatide regimens

ReferenceType: result

ReferenceCitation: Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Sanofi

location_country:
Germany
Poland
Romania
United States
Spain
Canada
Ukraine
Czech Republic
Russian Federation
France

location_facility:
Investigational Site Number 124113
Investigational Site Number 804105
Investigational Site Number 724101
Investigational Site Number 724105
Investigational Site Number 724102
Investigational Site Number 616102
Investigational Site Number 642104
Investigational Site Number 840113
Investigational Site Number 840101
Investigational Site Number 203103
Investigational Site Number 643104
Investigational Site Number 724106
Investigational Site Number 203105
Investigational Site Number 124102
Investigational Site Number 616101
Investigational Site Number 643102
Investigational Site Number 276105
Investigational Site Number 276102
Investigational Site Number 124110
Investigational Site Number 616107
Investigational Site Number 203102
Investigational Site Number 643108
Investigational Site Number 804106
Investigational Site Number 840120
Investigational Site Number 616104
Investigational Site Number 124105
Investigational Site Number 203106
Investigational Site Number 250102
Investigational Site Number 276108
Investigational Site Number 616103
Investigational Site Number 643105
Investigational Site Number 840115
Investigational Site Number 840122
Investigational Site Number 203101
Investigational Site Number 724107
Investigational Site Number 124106
Investigational Site Number 840103
Investigational Site Number 840110
Investigational Site Number 643110
Investigational Site Number 840118
Investigational Site Number 643107
Investigational Site Number 840119
Investigational Site Number 840114
Investigational Site Number 276101
Investigational Site Number 804103
Investigational Site Number 840105
Investigational Site Number 250105
Investigational Site Number 643101
Investigational Site Number 124103
Investigational Site Number 616106
Investigational Site Number 250103
Investigational Site Number 804108
Investigational Site Number 642103
Investigational Site Number 804101
Investigational Site Number 203104
Investigational Site Number 276103
Investigational Site Number 840112
Investigational Site Number 642101
Investigational Site Number 840111
Investigational Site Number 124104
Investigational Site Number 643103
Investigational Site Number 840102
Investigational Site Number 724103
Investigational Site Number 840104
Investigational Site Number 250108
Investigational Site Number 276104
Investigational Site Number 804104
Investigational Site Number 724108
Investigational Site Number 642102
Investigational Site Number 124111
Investigational Site Number 724104
Investigational Site Number 840107
Investigational Site Number 276107
Investigational Site Number 616105
Investigational Site Number 840116
Investigational Site Number 124108
Investigational Site Number 124112
Investigational Site Number 124101
Investigational Site Number 643106
Investigational Site Number 642105
Investigational Site Number 804102
Investigational Site Number 616108


title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

summary: The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

ReferenceType: derived

ReferenceCitation: Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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 pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.

oa_colors: green diamond

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: scielo

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
PubMed Central
pdfs.semanticscholar.org
scielo

publisher_dissemination: EDITORA SCIENTIFIC

ReferenceCitation: Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z.

oa_host_type: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.

ReferenceCitation: Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
China
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden


title: Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection

acronym: INSIGHT

summary: The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

ReferenceCitation: Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, Gonzalez-Garcia J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

lead_sponsor: Janssen-Cilag International NV

location_country:
Poland
United Kingdom
Australia
Brazil
Sweden
Spain
Russian Federation
France


title: A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)

acronym: BEGIN™

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.

ReferenceCitation: Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: green

publisher_dissemination: Hindawi

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Finland
Italy
North Macedonia
United Kingdom
Japan
Netherlands
United States
South Africa
Bulgaria
Russian Federation
France


title: Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

summary: This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

ReferenceCitation: Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

publisher_dissemination: American Diabetes Association

location_country:
Germany
Poland
United Kingdom
Denmark
Australia
Austria
Czech Republic
France


title: Evaluation of the Long Term Safety of the Use of Dabigatran Etexilate in Patients With a Bileaflet Mechanical Heart Valve

summary: To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Prevention

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.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Boehringer Ingelheim

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

location_facility: 1160.138.11007 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49010 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.11011 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.33002 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.49003 Boehringer Ingelheim Investigational Site

location_facility: 1160.138.48004 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

acronym: ATLAS

summary: The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

lead_sponsor: Biogen

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
France
Colombia
Portugal
Hungary
Hong Kong
United States
Belgium
Malaysia
Peru
Philippines
Italy
Mexico
Korea, Republic of
Spain
Russian Federation


title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

location_country:
Germany
France
Italy
United Kingdom
Argentina
Mexico
United States
Latvia
Spain
Malaysia
Taiwan
Philippines
Israel


title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

summary: This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.

ReferenceCitation: Santagostino E, Martinowitz U, Lissitchkov T, Pan-Petesch B, Hanabusa H, Oldenburg J, Boggio L, Negrier C, Pabinger I, von Depka Prondzinski M, Altisent C, Castaman G, Yamamoto K, Alvarez-Roman MT, Voigt C, Blackman N, Jacobs I; PROLONG-9FP Investigators Study Group. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016 Apr 7;127(14):1761-9. doi: 10.1182/blood-2015-09-669234. Epub 2016 Jan 11.

oa_colors: green other

publisher_dissemination: American Society of Hematology

lead_sponsor: CSL Behring

location_country:
Germany
Italy
Israel
Japan
Austria
United States
Spain
Bulgaria
Russian Federation
France

location_facility: Nara Medical University Hospital [PEDIATRICS]

location_facility: University of Occupational and Environmental Health

location_facility: Centre Hospitalier Universitaire de Brest/CHU Morvan

location_facility: Indiana Hemophilia and Thrombosis Center, Inc.

location_facility: FGU "Kirov Research Institute of Haemotology and Blood Trans

location_facility: IRCCS Ospedale Maggiore[Centro emofilia e Trombosi]

location_facility: Hospital of the University of Pennsylvania

location_facility: A.O.U. di Parma [Centro di Rif. Reg. per la cura dell'Emofil

location_facility: CHU de Lyon - Hôpital Edouard Herriot [Hemophilie]

location_facility: Universitätsklinikum Hamburg-Eppendorf, Abt für Pädiatr. Hämatologie

location_facility: SHAT "Joan Pavel" OOD [Hemorrhagic Diathesis and Anemia]

location_facility: Instit. für Experimentelle - Hämato & Transfusionsmedizin

location_facility: The Hospital of Hyogo College of Medicine

location_facility: St. Marianna University, School of Medicine, Yokohama Seibu

location_facility: Osp. S.Bortolo ULSS N.6 [Terapie Cell. ed Ematologia]

intervention_type: Biological


title: 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This study will assess the efficacy and safety of modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

ReferenceCitation: Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.

publisher_dissemination: Wiley

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Slovakia
Hungary
Switzerland
Austria
United States
Spain
Canada
France


title: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

summary: This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.

ReferenceCitation: Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.

oa_colors: green hybrid

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

location_country:
Germany
Australia
Brazil
Japan
Turkey
Croatia
France
Hungary
Denmark
Switzerland
United States
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
Taiwan
Bulgaria
Israel


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients with high-risk smoldering multiple myeloma (SMM).

ReferenceCitation: Brighton TA, Khot A, Harrison SJ, Ghez D, Weiss BM, Kirsch A, Magen H, Gironella M, Oriol A, Streetly M, Kranenburg B, Qin X, Bandekar R, Hu P, Guilfoyle M, Qi M, Nemat S, Goldschmidt H. Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Siltuximab in High-Risk Smoldering Multiple Myeloma. Clin Cancer Res. 2019 Jul 1;25(13):3772-3775. doi: 10.1158/1078-0432.CCR-18-3470. Epub 2019 Mar 19.

publisher_dissemination: American Association for Cancer Research

title: A Phase 2, Randomized, Blinded, Placebo-controlled, Multicenter Study of Siltuximab (Anti IL 6 Monoclonal Antibody) in Subjects With High-risk Smoldering Multiple Myeloma

source: euctr

location_country:
Germany
Israel
United Kingdom
Australia
Sweden
Belgium
United States
Korea, Republic of
Spain
Greece
France


title: A Multi-national Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Patients With Haemophilia A

summary: This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

ReferenceCitation: Giangrande P, Chowdary P, Enhrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WHO, Oldenburg J and on behalf of for the pathfinder™2 Investigators. Clinical evaluation of novel recombinant glycopegylated FVIII (turoctocog alfa pegol, N8-GP): efficacy and safety in previously treated patients with severe hemophilia A - results of pathfinder™2 international trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR212]

ReferenceCitation: Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jonsson PG, Oldenburg J; Pathfinder2 Investigators. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost. 2017 Jan 26;117(2):252-261. doi: 10.1160/TH16-06-0444. Epub 2016 Dec 1. Erratum In: Thromb Haemost. 2017 Jun;117(6):1163.

publisher_dissemination: Georg Thieme

ReferenceCitation: Giangrande P, Abdul Karim F, Nemes L, You CW, Landorph A, Geybels MS, Curry N. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. J Thromb Haemost. 2020 Sep;18 Suppl 1(Suppl 1):5-14. doi: 10.1111/jth.14959.

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

location_country:
Germany
Australia
Brazil
Japan
Turkey
Croatia
France
Hungary
Denmark
Switzerland
United States
Malaysia
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)

summary: The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

ReferenceCitation: Andersohn F, Claes AK, Kulp W, Mahlich J, Rockstroh JK. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016 Jan 11;16:10. doi: 10.1186/s12879-015-1311-3.

license: cc-by

license_normalized: cc-by

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: PubMed Central;refubium.fu-berlin.de

ReferenceCitation: Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

evidence: open (via page says license)

ReferenceCitation: Dieterich D, Rockstroh JK, Orkin C, Gutierrez F, Klein MB, Reynes J, Shukla U, Jenkins A, Lenz O, Ouwerkerk-Mahadevan S, Peeters M, De La Rosa G, Tambuyzer L, Jessner W. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014 Dec 1;59(11):1579-87. doi: 10.1093/cid/ciu675. Epub 2014 Sep 5.

lead_sponsor: Janssen R&D Ireland

location_country:
Germany
Portugal
United Kingdom
United States
Spain
Canada
Puerto Rico
France


title: PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment

acronym: PRESENT

summary:
Purpose of this trial:

To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF).
To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.

ReferenceCitation: Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.

ReferenceCitation: Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.

ReferenceCitation: Mittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29.

lead_sponsor: Galena Biopharma, Inc.

location_country:
Germany
Poland
Hungary
Israel
Romania
United Kingdom
United States
Ukraine
Bulgaria
Canada
Czech Republic
Russian Federation
France

location_facility: University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy

location_facility: Oncology Center "Sf. Nectarie", Department of Medical Oncology

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology

location_facility: Samara Regional Clinical Oncology Center

location_facility: Florida Cancer Research Institute (Florida Cancer Care)

location_facility: California Cancer Associates For Research and Excellence

location_facility: Kirovohrad Regional Oncology Center, Department of Mammology

location_facility: Multicare Health System-Research Institute

location_facility: Plymouth Oncology Centre, Derriford Hospital

location_facility: Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

location_facility: Polish Red Cross Marine Hospital, Department of Chemotherapy

location_facility: Medisprof SRL, Department of Medical Oncology

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

location_facility: Greater Poland Cancer Center, Department of Chemotherapy

location_facility: Interventional Spine and Pain Management

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Center of Cancer and Blood Disorders (VEEDA network)

location_facility: Petz Aladar County Teaching Hospital, Center for Oncoradiology

location_facility: Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration

location_facility: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

location_facility: Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center

location_facility: Oncomed SRL, Department of Medical Oncology

location_facility: Moores UC San Diego Cancer Center (UCSD)

location_facility: St. Alexius Medical Center, Mid Dakota Clinic, PC

location_facility: Hetenyi Geza Hospital, Department of Oncology

location_facility: Odesa Regional Clinical Hospital, Center for Mastology

location_facility: Coltea Clinical Hospital, Oncology Department

location_facility: Mariupol City Interdistrict Oncology Center, Surgery Department #2

location_facility: Chernivtsi Regional Clinical Oncology Center, Day Care Unit

location_facility: East Valley Hematology and Oncology Medical Group

location_facility: Nizhny Novgorod Regional Oncology Center

location_facility: Donetsk Regional Antitumor Center, Oncosurgery Department #2

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker

location_facility: Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council

location_facility: Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic

location_facility: Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center

location_facility: University Hospital Olomouc, Clinic of Oncology

location_facility: Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie

location_facility: Lahey Clinic Department of Hematology and Oncology

location_facility: University Hospital of North Staffordshire

location_facility: St. Jude Medical Center, Virginia K. Crosson Cancer Center

location_facility: Institut de Cancérologie de l'Ouest/René Gauducheau

location_facility: Dr. Constantin Opris County Emergency Hospital, Department of Oncology

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Non-Public Health Care Facility MAGODENT

location_facility: Stamford Hospital, Bennett Cancer Center

location_facility: UT Southwestern Medical Center / Simmons Comprehensive Cancer Center

location_facility: Western Connecticut Health Network, Danbury Hospital

location_facility: Semmelweis University, Department of Diagnostic Radiology and Oncotherapy

location_facility: Kyiv City Clinical Oncology Center, Department of Chemotherapy

location_facility: Vinnytsia Regional Clinical Oncology Center

location_facility: Kaposi Mor County Teaching Hospital, Center for Clinical Oncology

location_facility: N.N. Blokhin Russian Cancer Reserach Center

location_facility: Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum

location_facility: Cancer Specialists of North Florida (ICON)

location_facility: Rotkreuzklinikum München gGmbH, Frauenklinik

location_facility: University of Colorado Cancer Center, Anschutz Medical Campus

location_facility: Mechnikov North-Western State Medical University

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Conemaugh Memorial Hospital-Memorial Medical Center

location_facility: Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council

location_facility: Institut de Cancérologie de l'Ouest Siet Paul Papin

location_facility: Szent Margit Hospital, V. Department of Internal Medicine, Oncology

location_facility: University of Pittsburgh Medical Center (UPMC) Cancer Center

location_facility: University of Southern California/Norris Cancer Hospital

location_facility: Brustzentrum Klinikum Bremen-Mitte gGmbH

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center

location_facility: Iasi Regional Oncology Institute, Department of Medical Oncology

location_facility: Filantropia Clinical Hospital, Obstetrics and Gynaecology Department

location_facility: South Orange County Surgical Medical Group

location_facility: The West Clinic Comprehensive Breast Center

location_facility: Bucharest Universtiy Emergency Hosptial, Oncology Department

location_facility: Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Academic Unit of Oncology, Nottingham University Hospital-City Campus

location_facility: Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy

location_facility: Krasnoyarsk Kryzhanovsky Regional Oncology Center

location_facility: James Graham Brown Cancer Center, University of Louisville

location_facility: Leeds Teaching Hospitals Trust, St. James University Hospital

location_facility: Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum

location_facility: Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration

location_facility: State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine

location_facility: General University Hospital in Prague, Clinic of Oncology

location_facility: H.Lee Moffitt Cancer Center and Research Institute

location_facility: University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Kharkiv Regional Clinical Oncology Center, Day Care Unit

location_facility: Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: "Gavril Curteanu" Municipal Clinical Hospital

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: Physicians Pain Specialists of Alabama, P.C.

location_facility: Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik

location_facility: Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology

location_facility: Tambov Regional Clinical Oncology Center


title: A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy

acronym: PACE

summary: The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

ReferenceCitation: Vinik AI, Perrot S, Vinik EJ, Pazdera L, Jacobs H, Stoker M, Long SK, Snijder RJ, van der Stoep M, Ortega E, Katz N. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016 Dec 6;16(1):251. doi: 10.1186/s12883-016-0752-7.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Belgium
Spain
Ukraine
Czech Republic
Russian Federation
France

location_facility:
Site: 903
Site: 801
Site: 505
Site: 202
Site: 911
Site: 713
Site: 965
Site: 957
Site: 961
Site: 304
Site: 401
Site: 303
Site: 805
Site: 951
Site: 711
Site: 404
Site: 810
Site: 507
Site: 807
Site: 806
Site: 512
Site: 514
Site: 901
Site: 802
Site: 815
Site: 305
Site: 709
Site: 506
Site: 813
Site: 101
Site: 601
Site: 501
Site: 651
Site: 207
Site: 954
Site: 808
Site: 904
Site: 812
Site: 714
Site: 201
Site: 909
Site: 960
Site: 708
Site: 704
Site: 103
Site: 902
Site: 703
Site: 803
Site: 104
Site: 509
Site: 508
Site: 206
Site: 953
Site: 966
Site: 706
Site: 964
Site: 102
Site: 502
Site: 716
Site: 910
Site: 959
Site: 958
Site: 906
Site: 908


title: Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing

summary: The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
India
Hungary
Romania
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Greece
Croatia
Turkey
France

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: An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

summary: The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

ReferenceCitation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

ReferenceCitation: Gokbuget N, Kantarjian HM, Bruggemann M, Stein AS, Bargou RC, Dombret H, Fielding AK, Heffner L, Rigal-Huguet F, Litzow M, O'Brien S, Zugmaier G, Gao S, Nagorsen D, Forman SJ, Topp MS. Molecular response with blinatumomab in relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Blood Adv. 2019 Oct 22;3(20):3033-3037. doi: 10.1182/bloodadvances.2019000457.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
UCL Discovery
escholarship.org

ReferenceCitation: Zhu M, Kratzer A, Johnson J, Holland C, Brandl C, Singh I, Wolf A, Doshi S. Blinatumomab Pharmacodynamics and Exposure-Response Relationships in Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Pharmacol. 2018 Feb;58(2):168-179. doi: 10.1002/jcph.1006. Epub 2017 Sep 18.

ReferenceCitation: Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

ReferenceCitation: Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

ReferenceCitation: Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foa R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Bruggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158.

lead_sponsor: Amgen Research (Munich) GmbH

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II

location_facility: Klinikum der Goethe Universität, Medizinische Klinik II

location_facility: Washington University School of Medicine

location_facility: Winship Cancer Institute of Emory University


title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

acronym: IMAGINE 3

summary:
The purpose of this study is:

To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

ReferenceCitation: Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

publisher_dissemination: SAGE Publications

ReferenceCitation: Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

location_country:
Ireland
Poland
New Zealand
Australia
Brazil
Croatia
Canada
France
Lithuania
Slovakia
Denmark
United States
Belgium
United Kingdom
Sweden
Netherlands
Spain
Greece
South Africa
Israel


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.

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.

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

location_facility: 1160.113.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49010 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11007 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32007 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11006 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49008 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32005 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.46003 Skånes Universitetssjukhus Lund

location_facility: 1160.113.33001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49002 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11011 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33004 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.49003 Boehringer Ingelheim Investigational Site

location_facility: 1160.113.33002 Boehringer Ingelheim Investigational Site


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

ReferenceCitation: Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601. Erratum In: J Clin Oncol. 2019 Dec 1;37(34):3327.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: University Of Texas, M. D. Anderson Cancer Center

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C.

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Signal Point Clinical Research Center, Llc

location_facility: Presence Medical Group Hematology Oncology

location_facility: St. Francis Medical Group Oncology And Hematology Specialist

location_facility: Regional Cancer Care Associates, LLC/Cherry Hill Division

title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
China
Peru
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

summary: This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

ReferenceCitation: Hendriksz CJ, Parini R, AlSayed MD, Raiman J, Giugliani R, Mitchell JJ, Burton BK, Guelbert N, Stewart FJ, Hughes DA, Matousek R, Hawley SM, Decker C, Harmatz PR. Impact of long-term elosulfase alfa on activities of daily living in patients with Morquio A syndrome in an open-label, multi-center, phase 3 extension study. Mol Genet Metab. 2018 Feb;123(2):127-134. doi: 10.1016/j.ymgme.2017.11.015. Epub 2017 Dec 5.

repository_institution: University of Pretoria - UpSpace Institutional Repository

repositories_concat: UCL Discovery;repository.up.ac.za

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Hughes D, Giugliani R, Guffon N, Jones SA, Mengel KE, Parini R, Matousek R, Hawley SM, Quartel A. Clinical outcomes in a subpopulation of adults with Morquio A syndrome: results from a long-term extension study of elosulfase alfa. Orphanet J Rare Dis. 2017 May 23;12(1):98. doi: 10.1186/s13023-017-0634-0.

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repository_institution: AECID Library - Americanae

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery
americanae.aecid.es

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery;americanae.aecid.es

ReferenceCitation: Long B, Tompkins T, Decker C, Jesaitis L, Khan S, Slasor P, Harmatz P, O'Neill CA, Schweighardt B. Long-term Immunogenicity of Elosulfase Alfa in the Treatment of Morquio A Syndrome: Results From MOR-005, a Phase III Extension Study. Clin Ther. 2017 Jan;39(1):118-129.e3. doi: 10.1016/j.clinthera.2016.11.017. Epub 2016 Dec 10.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Argentina
Japan
Brazil
Turkey
Canada
France
Colombia
Portugal
Denmark
Qatar
United States
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Saudi Arabia
Spain
Taiwan


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.

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

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

location_facility: Memorial Sloan Kettering Cancer Center MSK 2

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

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

location_facility: Hackensack University Medical Center Hackensack (SC)


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.

repository_institution: Monash University - Monash University Research Portal

repository_institution: Erasmus University Rotterdam - EUR Research Repository

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals, Inc.

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


acronym: PERIWINKLE

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

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.

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.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Katedra i Klinika Neurologii Wieku Rozwojowego

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: General Childrens Hospital of Athens P & A Kyriakou

location_facility: Cliniques Universitaires de Bruxelles Hôpital Erasme

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

location_facility: Centre Hospitalier Neurologique William Lennox

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

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

location_facility: Center for Neurodiagnostic and Therapeutic Services

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

location_facility: University of Kentucky Hospital Epilepsy Monitoring Unit

location_facility: University of Kentucky Hospital Pharmacy, UK Chandler Hosptial

location_facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly

location_facility: Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak

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

location_facility: Spitalul clinic de copii Dr. Victor Gomoiu

location_facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital

location_facility: Center for Clinical and Translational Science

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: Dr. Kenessey Albert Korhaz es Rendelointezet

location_facility: Duke Children's Hospital and Health Center

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

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

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

location_facility: Institute for Child and Youth Healthcare of Vojvodina

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

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

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

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

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

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: Fakultni nemocnice Brno - Detska nemocnice

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

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

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

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia

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

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

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

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

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.

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

ipd_sharing: Yes


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)

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.

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


title: A 4 Week, Dose-Ranging, Multi-Center, Randomized, Double-Masked, Parallel Study Comparing The Efficacy, Safety, And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma Aand Ocular Hypertension

summary: The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.

ReferenceCitation: Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 mug/mL to latanoprost 50 mug/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.

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

location_country:
Portugal
United Kingdom
Australia
Thailand
Greece
Pakistan
Czechia
France

location_facility: Akadimos Ophthalmology Center of Northern Greece

location_facility: Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital

location_facility: Specializovana Glaukomova Poradna, Blanicka 25

location_facility: Institute of Aviation Medicine, Generalal Piky 1


title: An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

summary: This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Netherlands
United States
Spain
Canada
France


title: A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

acronym: PERSIST

summary: This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
France
Poland
Slovakia
Hungary
Argentina
Australia
Japan
United States
Croatia
Chile
Bulgaria
Serbia
Russian Federation
Czech Republic

location_facility: Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: Mental Health Research Institute of Rams

location_facility: State Healthcare and Forensic Psychiatric Expertise Institution

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique

location_facility: University Multiprofiled Hospital for Active Treatment "Sveti Georgi"

location_facility: CHRU de Nimes, Service de Psychiatrie adulte

location_facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

location_facility: Psychiatric Clinic Clinical Center Kragujevac

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria

location_facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

location_facility: Prywatny Gabinet Lekarski Jaroslaw Strzelec

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: St.Petersburg State Healthcare Institution (SPSHI)

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria

location_facility: Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava

location_facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

location_facility: Psychiatric Clinic, Military Medical Academy

location_facility: St Petersburg State Government Healthcare Institution

location_facility: Clinic Hospital Centre Rijeka Clinic for Psychiatry

location_facility: Nagano Prefectural Mental Wellness Center-Komagane

location_facility: Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy

location_facility: Clinical Hospital Centre Dragisa Misovic

location_facility: Centro de Atencion E Invest. Clinica (CAICI)

location_facility: Multprofiled Hospital for Active Treatment "Sveta Marina"

location_facility: St. Petersburg State Healthcare Institution (SPSHI)

location_facility: Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu

location_facility: IPEM-Instituto de Prevención de las Enfermedades Mentales.

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"

location_facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz


title: A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

acronym: ATTAIN

summary: The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.

ReferenceCitation: Arnold DL, Shang S, Dong Q, Meergans M, Naylor ML. Peginterferon beta-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418795085. doi: 10.1177/1756286418795085. eCollection 2018.

ReferenceCitation: Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA. Single-use autoinjector for peginterferon-beta1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 10.1517/17425247.2014.944159. Epub 2014 Jul 29.

location_country:
Germany
Poland
New Zealand
Croatia
Chile
Canada
Serbia
France
Czech Republic
Colombia
United States
Latvia
Ukraine
India
Romania
Belgium
Peru
Estonia
United Kingdom
Netherlands
Mexico
Spain
Greece
Bulgaria
Georgia
Russian Federation


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.

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.

lead_sponsor: Denovo Biopharma LLC

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

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: A Phase III, Open-Label, Single Arm, Rollover Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.

summary: The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

ReferenceCitation: Gane EJ, DeJesus E, Janczewska E, George J, Diago M, Da Silva MH, Reesink H, Nikitin I, Hinrichsen H, Bourgeois S, Ferenci P, Shukla U, Kalmeijer R, Lenz O, Fevery B, Corbett C, Beumont M, Jessner W. Simeprevir with peginterferon alpha-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study. BMC Infect Dis. 2017 Jun 2;17(1):389. doi: 10.1186/s12879-017-2444-3.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Canada
France
Portugal
United States
Ukraine
Romania
Belgium
Puerto Rico
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation
Israel


title: A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD

summary: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.

ReferenceCitation: Maleki-Yazdi MR, Singh D, Anzueto A, Tombs L, Fahy WA, Naya I. Assessing Short-term Deterioration in Maintenance-naive Patients with COPD Receiving Umeclidinium/Vilanterol and Tiotropium: A Pooled Analysis of Three Randomized Trials. Adv Ther. 2017 Jan;33(12):2188-2199. doi: 10.1007/s12325-016-0430-6. Epub 2016 Oct 28.

ReferenceCitation: Decramer M, Anzueto A, Kerwin E, Kaelin T, Richard N, Crater G, Tabberer M, Harris S, Church A. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014 Jun;2(6):472-86. doi: 10.1016/S2213-2600(14)70065-7. Epub 2014 May 14.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
Romania
Mexico
United States
Peru
Ukraine
Russian Federation
France


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis Who Have Not Been Previously Treated With Disease-modifying Antirheumatic Drugs

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

ReferenceCitation: Mease PJ, Kavanaugh A, Ogdie A, Wells AF, Bergman M, Gladman DD, Richter S, Teng L, Jardon S, Smolen JS. Baseline Disease Activity Predicts Achievement of cDAPSA Treatment Targets With Apremilast: Phase III Results in DMARD-naive Patients With Psoriatic Arthritis. J Rheumatol. 2022 Jul;49(7):694-699. doi: 10.3899/jrheum.210906. Epub 2022 Apr 15.

ReferenceCitation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Guerette B, Delev N, Paris M, Teng L, Aelion JA. Apremilast monotherapy for long-term treatment of active psoriatic arthritis in DMARD-naive patients. Rheumatology (Oxford). 2022 Mar 2;61(3):1035-1043. doi: 10.1093/rheumatology/keab449.

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

ReferenceCitation: Wells AF, Edwards CJ, Kivitz AJ, Bird P, Nguyen D, Paris M, Teng L, Aelion JA. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford). 2018 Jul 1;57(7):1253-1263. doi: 10.1093/rheumatology/key032.

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

lead_sponsor: Amgen

location_country:
Italy
Lithuania
Bulgaria
Poland
New Zealand
Hungary
United Kingdom
Romania
Australia
Belgium
United States
Korea, Republic of
Taiwan
Czechia
Canada
Estonia
Russian Federation
France

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Menzies Centre for Population Health Research

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

location_facility: Atlanta Dermatology, Vein and Research Center, PC

location_facility: Veterans of Wars Regional Clinical Hospital

location_facility: Research Institute of Clinical Immunology

location_facility: AOU della II Universita degli Studi di Napoli

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Bytomskie Centrum Medyczne Silesiana Sp. z o.o.

location_facility: Multiprofile Hospital for Active Treatment Trimontsium

location_facility: Clinical Research Center of Reading, LLP

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej REUMED

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Honvéd Kórház - Állami Egészségügyi Központ

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: Unifour Medical Research Associatets LLC

location_facility: St. Clare's Health Care Corporation of St. John's

location_facility: Kemerovo State Medical Academy of Roszdrav

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: 17 Diagnostic and Consulting Centre Sofia EOOD


title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).

location_country:
United States
France

location_facility: The Center For Pharmaceutical Research. Pc

location_facility: Comprehensive Clinical Development, Inc.