title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.

ReferenceCitation: Rolfo C, de Vos-Geelen J, Isambert N, Molife LR, Schellens JHM, De Grève J, Dirix L, Grundtvig-Sørensen P, Jerusalem G, Leunen K, Mau-Sørensen M, Plummer R, Learoyd M, Bannister W, Fielding A, Ravaud A. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment. Clin Pharmacokinet. 2019 Sep;58(9):1165-1174. doi: 10.1007/s40262-019-00754-4.

lead_sponsor: AstraZeneca

location_country:
Denmark
United Kingdom
France
Belgium
Netherlands


type: Other Identifier

title: International (Pediatric) Peritoneal Biobank

summary:
Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.

An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.

3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Catar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jörres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu.2022.821681. eCollection 2022.

ReferenceCitation: Bartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. Epub 2021 Jul 8.

lead_sponsor: Heidelberg University

location_country:
Poland
Spain
Italy
Austria
Lithuania
Switzerland
Sweden
Hungary
France
United States
Malaysia
Turkey
Belgium
Germany
Czechia

location_facility: Department of Pediatrics, Medical University Vienna

location_facility: KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg

location_facility: Children's Hospital, Inselspital, Bern University Hospital and University of Bern

location_facility: Department of Medicine I (Nephrology), University of Heidelberg

location_facility: Paediatric CAPD unit, Kuala Lumpur Hospital

location_facility: Hospital Universitario Materno-Infantil Vall d' Hebron

location_facility: Krakow, Jagiellonian University Medical College

location_facility: Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant

location_facility: Pediatric Nephrology, Dialysis and Transplant Unit

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Randomized, Double Blind, Placebo Controlled, Two Parallel Group Study to Evaluate the Efficacy and Safety of Piracetam, 12 g Intravenous (IV) Infusion Within 7 Hour (h) Post Stroke Onset, Followed by 12 g/d for 4 Weeks (IV Ampoules, Oral Solution) and 4.8 g/d for 8 Weeks (Tablets) in Adult Subjects With an Acute Ischemic Middle Cerebral Artery Stroke

summary: The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral artery stroke and having received their medication within 7 h post-stroke onset.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: UCB S.A. - Pharma Sector

location_country: Poland Taiwan Spain Greece Austria Italy Argentina Sweden Hungary France Singapore Turkey Belgium Norway Germany

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

acronym: OPAL BEYOND

summary: To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

study_start_date_type: Actual

status: Completed

ReferenceCitation: de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.

ReferenceCitation: Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.

ReferenceCitation: Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.

ReferenceCitation: Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.

ReferenceCitation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.

ReferenceCitation: de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2). pii: e001609. doi: 10.1136/rmdopen-2021-001609.

ReferenceCitation: Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

ReferenceCitation: Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.

ReferenceCitation: Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

ReferenceCitation: Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Chen L, Kudlacz E, Wu J, Cappelleri JC, Hendrikx T, Hsu MA. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond. RMD Open. 2019 Jan 11;5(1):e000808. doi: 10.1136/rmdopen-2018-000808. eCollection 2019.

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.

RetractionSource: J Patient Rep Outcomes. 2019 May 28;3(1):32

ReferenceCitation: Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.

ReferenceCitation: Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.

ReferenceCitation: Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.

lead_sponsor: Pfizer

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Russian Federation
Australia
Mexico
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS

location_facility: Christus Muguerza del parque, S.A de C.V

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Hospital General de Culiacan "Dr. Bernardo J. Gastelum"

location_facility: Universitaetsklinikum Erlangen, Medizinische Klinik 3

location_facility: Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)

location_facility: SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow

location_facility: University Hospitals Case Medical Center

location_facility: State Budget Educational Institution of Highest Professional Education

location_facility: Medica Sur, S.A.B. de C.V. (For Emergencies Only)

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: Drug Shipment/Storage: Investigational Drug Services

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Centro Multidisciplinario para el Desarrollo

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Royal Prince Alfred Hospital, Rheumatology Department

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

location_facility: State Autonomic Healthcare Institution City Clinical Hospital # 7

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Centro de Investigacion Clinica Pensiones

location_facility: Radiologia Clínica de Campinas - RCC (Images only)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Erasme - Clinique Universitaire de Bruxelles

location_facility: Hospital Universitaro Y Politecnico La Fe

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: MEDMAN s.r.o. - reumatologicka ambulancia

location_facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C

location_facility: Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only

location_facility: State Institution of Healthcare of Yaroslavl Region

location_facility: Rheumatology Associates of Central Florida, PA

location_facility: St. Luke's Intermountain Research Center

location_facility: Royal United Hospitals NHS Foundation Trust

location_facility: City Neurological Centre "SibNeyroMed", LLC

location_facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: CETAC - DIAGNOSTICO POR IMAGEM (image only)

location_facility: CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Star Medica S.A. de C.V. (For Emergencies Only)

location_facility: Adriana M. Pop-Moody, M.D., Clinic, P.A.

location_facility: Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.

location_facility: Integral Rheumatology & Immunology Specialists (IRIS)

location_facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: York Hospital, York Teaching Hospital NHS Foundation Trust

location_facility: Charite Universitatsmedizin Berlin - Campus Charite Mitte

location_facility: Wojewodzki Szpital Zespolony Zaklad Radiologii

location_facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

location_facility: Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

location_facility: The Center For Rheumatology And Bone Research

status_simplified: Completed


title: APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia

acronym: APRICOT

summary:
The aims of the APRICOT study are:

To establish the incidence of severe critical events in children undergoing anesthesia in Europe.
To describe the differences in paediatric anaesthesia practice throughout Europe.
To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

ReferenceCitation: Dahmani S, Laffargue A, Dadure C, Veyckemans F; French APRICOT trial group. Description of practices and complications in the French centres that participated to APRICOT: A secondary analysis. Anaesth Crit Care Pain Med. 2019 Dec;38(6):637-645. doi: 10.1016/j.accpm.2019.06.001. Epub 2019 Jun 11.

ReferenceCitation: Virag K, Sabourdin N, Thomas M, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Epidemiology and incidence of severe respiratory critical events in ear, nose and throat surgery in children in Europe: A prospective multicentre observational study. Eur J Anaesthesiol. 2019 Mar;36(3):185-193. doi: 10.1097/EJA.0000000000000951.

ReferenceCitation: Engelhardt T, Virag K, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Airway management in paediatric anaesthesia in Europe-insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe. Br J Anaesth. 2018 Jul;121(1):66-75. doi: 10.1016/j.bja.2018.04.013. Epub 2018 May 18.

ReferenceCitation: Habre W, Disma N, Virag K, Becke K, Hansen TG, Jöhr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28. Erratum in: Lancet Respir Med. 2017 May;5(5):e19. Lancet Respir Med. 2017 Jun;5(6):e22.

lead_sponsor: European Society of Anaesthesiology

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
Belgium
Romania
Poland
Portugal
Slovenia
Austria
Russian Federation
Israel
Malta
Turkey
Norway
Gibraltar
Sweden
Slovakia
Switzerland
Germany
Kosovo
Denmark
Greece
Ireland
Estonia
Latvia
Finland
Czech Republic
France
Netherlands

location_facility: Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia

location_facility: Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse

location_facility: Gibraltar Health Authority, St. Bernard´s Hospital

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1

location_facility: Pirogov Russian National Research Medical University

location_facility: Clinical University Hospital Department of Anaesthesiology and Intensive Care

location_facility: Maastricht University Medical Center MUMC

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Schneider Children's Medical center of Israel

location_facility: Queen Silvis Childrens Hospital Sahlgrens University Hospital


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

summary:
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

ReferenceCitation: Klein P, Aboumatar S, Brandt C, Dong F, Krauss GL, Mizne S, Sanchez-Alvarez JC, Steinhoff BJ, Villanueva V. Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. Neurology. 2022 Jun 15. pii: 10.1212/WNL.0000000000200792. doi: 10.1212/WNL.0000000000200792. [Epub ahead of print]

ReferenceCitation: Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.

ReferenceCitation: Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14. Erratum in: Lancet Neurol. 2020 Mar;19(3):e3.

ReferenceCitation: Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19. Review.

lead_sponsor: SK Life Science, Inc.

location_country:
Poland
Serbia
Spain
Australia
Thailand
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Romania
Germany
Bulgaria
Czechia

location_facility: The Comprehensive Epilepsy Care Center for Children and Adults

location_facility: Kaiser Permanente, Department of Neurology

location_facility: Fundacja Epileptologii profesora Jerzego Majkowskiego

location_facility: Western Galilee Hospital, Department of Neurology

location_facility: Hôpital Central - CHU de Nancy - Service de Neurologie

location_facility: Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna

location_facility: Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah

location_facility: University of Virginia Comprehensive Epilepsy Program

location_facility: Epilepsy Research Centre, Melbourne Brain Centre

location_facility: Hospital Clinico Universitario San Carlos, Serv. Neurologia

location_facility: Lviv Regional Antiepileptic Center based on Department of Neurology of Lviv Regional Clinical Hospital and Chair of Neurology of Lviv National Medical University n.a. Danylo Galytskyy

location_facility: Clinical of Neurology, Clinical Center of Serbia

location_facility: Thomas Jefferson Comprehensive Epilepsy Center

location_facility: Fundación Jiminez Diaz-Servicio de Neurologia

location_facility: Roceanu Adina Maria Neurology Individual Medical Center

location_facility: University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases

location_facility: TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"

location_facility: MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department

location_facility: Fakultní nemocnice Ostrava, Neurologická klinika

location_facility: Hospital Universitario y Politecnico La Fe - Servicio Neurologia

location_facility: "First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic

location_facility: Fakultni nemocnice v Motole, Neurologická klinika

location_facility: University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases

location_facility: The Chaim Sheba Medical Center, Department of Neurology

location_facility: Consultants in Epilepsy & Neurology, PLLC

location_facility: Neurology of Kharkiv Medical Academy of Postgraduate Education based on Department of Neurology #3 of State Treatment and Prevention Institution "Central Clinical Hospital of Ukrzaliznytsya"

location_facility: Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"

location_facility: Institute of Neurological Sciences, Prince of Wales Hospital

location_facility: Hospital Ruber Internacional - Programa Epilepsia

location_facility: Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics

location_facility: Department #2 of Regional Clinical Center of Neurosurgery and Neurology

location_facility: Hospital Universitario San Cecilio - Servicio de Neurologia

location_facility: West Los Angeles VA Medical Center, Clinical Research Center

location_facility: M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: NOVO-MED Zielinski I Wspolnicy Spolka Jawna

intervention_type: Drug


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

summary: The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

ReferenceType: background

ReferenceCitation: McDonald CM, Henricson EK, Han JJ, Abresch RT, Nicorici A, Elfring GL, Atkinson L, Reha A, Hirawat S, Miller LL. The 6-minute walk test as a new outcome measure in Duchenne muscular dystrophy. Muscle Nerve. 2010 Apr;41(4):500-10. doi: 10.1002/mus.21544.

ReferenceCitation: Victor RG, Sweeney HL, Finkel R, McDonald CM, Byrne B, Eagle M, Goemans N, Vandenborne K, Dubrovsky AL, Topaloglu H, Miceli MC, Furlong P, Landry J, Elashoff R, Cox D; Tadalafil DMD Study Group. A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy. Neurology. 2017 Oct 24;89(17):1811-1820. doi: 10.1212/WNL.0000000000004570. Epub 2017 Sep 29.

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Argentina
Canada
Korea, Republic of
United States
France
Puerto Rico
Turkey
Belgium
Japan
Germany

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Univ of Texas Health Science Center at San Antonio

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

location_facility: University of California, Davis - Health Systems

location_facility: Pennsylvania State University College of Medicine

location_facility: University of Florida Health Science Center

location_facility: University of Puerto Rico, Medical Sciences Campus

location_facility: Ann and Robert Lurie Children's Hospital of Chicago


title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.

lead_sponsor: Novartis Pharmaceuticals

source: euctr

location_country:
Spain
Italy
Lithuania
Peru
Poland
Portugal
Russian Federation
Australia
Turkey
Singapore
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
Czech Republic
Korea, Republic of
France

summary: This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).


title: A Cross-sectional Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

summary:
No investigational drug will be administered in this study for the treatment of Fabry disease.

This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact.

The objectives of the study are:

To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease.
To provide a reference group for comparison with interventional clinical trials of Fabry disease.

The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.

primary_purpose: Basic Science

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Austria
Argentina
Canada
Finland
Hungary
United States
France
Belgium
Norway

location_facility:
Investigational Site Number 040001
Investigational Site Number 840006
Investigational Site Number 032001
Investigational Site Number 246002
Investigational Site Number 616001
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 826002
Investigational Site Number 724002
Investigational Site Number 840009
Investigational Site Number 578001
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 158001
Investigational Site Number 826004
Investigational Site Number 056001
Investigational Site Number 124001
Investigational Site Number 840002
Investigational Site Number 348001
Investigational Site Number 840003
Investigational Site Number 076001
Investigational Site Number 250001


title: A Phase 2, Randomized, Double Blind Placebo Controlled Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of Pf-04360365 (Ponezumab) In Adult Subjects With Probable Cerebral Amyloid Angiopathy

summary: Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.

location_country:
United Kingdom
Canada
United States
France
Netherlands

location_facility: Anthinoula A. Martinos Center for Biomedical Imaging

location_facility: University of Calgary/Foothills Medical Centre

intervention_type: Biological


title: An Open-Label, Multicenter, Phase 1 Study With Expansion Cohorts of Ramucirumab or Necitumumab in Combination With Osimertinib in Patients With Advanced T790M-Positive EGFR-Mutant Non-Small Cell Lung Cancer After Progression on First-Line EGFR TKI Therapy

summary: The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).

design_allocation: Non-Randomized

ReferenceCitation: Yu HA, Paz-Ares LG, Yang JC, Lee KH, Garrido P, Park K, Kim JH, Lee DH, Mao H, Wijayawardana SR, Gao L, Hozak RR, Chao BH, Planchard D. Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer. Clin Cancer Res. 2021 Feb 15;27(4):992-1002. doi: 10.1158/1078-0432.CCR-20-1690. Epub 2020 Oct 12.

location_country:
Taiwan
Spain
Korea, Republic of
United States
France


title: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

ipd_sharing: No

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Poland
Spain
Italy
Ireland
Netherlands
United Kingdom
France
Germany

location_facility: Cardio Vasculares Centrum Sankt Katharinen

location_facility: Clinical Hospital University of Medicine

intervention_type: Device


title: Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker

summary: This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

lead_sponsor: Biotronik SE & Co. KG

location_country:
Austria
Australia
Canada
Czech Republic
Switzerland
Hungary
France
Germany

location_facility: Schwarzwald Baar Klinikum Villingen Schwenningen

location_facility: CHUS - Centre hospitalier universitaire de Sherbrooke


title: Intensive Enteral Nutrition in Association With Corticosteroids in Severe Acute Alcoholic Hepatitis: a Multicenter, Randomized, Controlled Trial

summary: To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in association with corticosteroïds in patients with severe acute alcoholic hepatitis.

ReferenceCitation: Moreno C, Deltenre P, Senterre C, Louvet A, Gustot T, Bastens B, Hittelet A, Piquet MA, Laleman W, Orlent H, Lasser L, Sersté T, Starkel P, De Koninck X, Negrin Dastis S, Delwaide J, Colle I, de Galocsy C, Francque S, Langlet P, Putzeys V, Reynaert H, Degré D, Trépo E. Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids. Gastroenterology. 2016 Apr;150(4):903-10.e8. doi: 10.1053/j.gastro.2015.12.038. Epub 2016 Jan 5.

lead_sponsor: Erasme University Hospital

location_country: France Belgium

location_facility:
UZ Antwerpen
Hôpitaux Iris-Sud
Erasme University Hospital
Hôpital Ottignies
UZ Gent
Hôpital Saint-Joseph
CHU Caen
KU Leuven
ULG Sart Tilman
CHU Lille
CHR La Citadelle
CHU Saint-Pierre
Hôpital Ambroise Paré
Cliniques universitaires Saint-Luc
CHU Brugmann
AZ Brugge
CHR Saint Joseph-Warquignies
AZ VUB
Hôpital de Jolimont

intervention_type: Dietary Supplement


title: A Multi-centre Randomized, Placebo-controlled Trial of Mirabegron, a New beta3-adrenergic Receptor Agonist on Left Ventricular Mass and Diastolic Function in Patients With Structural Heart Disease

summary:
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II).

Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.

status: Active, not recruiting

ReferenceCitation: Belge C, Hammond J, Dubois-Deruy E, Manoury B, Hamelet J, Beauloye C, Markl A, Pouleur AC, Bertrand L, Esfahani H, Jnaoui K, Götz KR, Nikolaev VO, Vanderper A, Herijgers P, Lobysheva I, Iaccarino G, Hilfiker-Kleiner D, Tavernier G, Langin D, Dessy C, Balligand JL. Enhanced expression of β3-adrenoceptors in cardiac myocytes attenuates neurohormone-induced hypertrophic remodeling through nitric oxide synthase. Circulation. 2014 Jan 28;129(4):451-62. doi: 10.1161/CIRCULATIONAHA.113.004940. Epub 2013 Nov 4.

ReferenceCitation: Balligand JL. beta(3)-Adrenoceptor stimulation on top of beta(1)-adrenoceptor blockade "Stop or Encore?". J Am Coll Cardiol. 2009 Apr 28;53(17):1539-42. doi: 10.1016/j.jacc.2009.01.048.

ReferenceCitation: Dessy C, Balligand JL. Beta3-adrenergic receptors in cardiac and vascular tissues emerging concepts and therapeutic perspectives. Adv Pharmacol. 2010;59:135-63. doi: 10.1016/S1054-3589(10)59005-7. Review.

lead_sponsor: Jean-Luc Balligand

location_country:
Poland
Portugal
United Kingdom
Italy
Greece
France
Belgium
Germany

location_facility: Center for Cardiovascular Research Berlin (CCR/Charité)

location_facility: University Medical Center Göttingen (UMG-GOE)

location_facility: Association for Research and Development of the Faculty of Medicine (AIDFM)

location_facility: Department of Heart Diseases at Wroclaw Medical University (UMW)

location_facility: University of Oxford - Division of Cardiovascular Medicine (UOXF)

intervention_type: Radiation


primary_purpose: Other

acronym: Einstein Jr

title: 7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis

lead_sponsor: Bayer

ReferenceCitation: Monagle P, Lensing AWA, Thelen K, Martinelli I, Male C, Santamaría A, Samochatova E, Kumar R, Holzhauer S, Saracco P, Simioni P, Robertson J, Grangl G, Halton J, Connor P, Young G, Molinari AC, Nowak-Göttl U, Kenet G, Kapsa S, Willmann S, Pap AF, Becka M, Twomey T, Beyer-Westendorf J, Prins MH, Kubitza D; EINSTEIN-Jr Phase 2 Investigators. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. Lancet Haematol. 2019 Oct;6(10):e500-e509. doi: 10.1016/S2352-3026(19)30161-9. Epub 2019 Aug 13.

location_country: Spain Italy Austria France Israel Turkey Germany

summary: The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.


title: Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation

summary: The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.

lead_sponsor: Prof. Dr. Petra Reinke

location_country:
Spain
United Kingdom
Netherlands
France
Germany
Czechia

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Academisch Medisch Centrum bij de Universiteit van Amsterdam

location_facility: Department Nephrology and BCRT, Charité Universitätsmedizin Berlin

location_facility: Institut klinické a experimentální mediciny


title: An Open-Label, Four-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and the Anti-EGFR Antibody Panitumumab in Combination in Subjects With BRAF-mutation V600E Positive Colorectal Cancer and in Subjects With CRC With Secondary Resistance to Prior Anti-EGFR Therapy

summary: This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC. The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD for double (T+P) combination in Part 4A, and assess clinical activity of this combination in two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to anti-EGFR therapy).

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

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

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium
Japan
Netherlands


title: A Phase II Trial of Pemetrexed and Cisplatin or Carboplatin in Combination With TTFields (150 kHz) as First-line Treatment in Malignant Pleural Mesothelioma

summary: The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

ReferenceCitation: Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9. Review.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Ceresoli GL, Aerts JG, Dziadziuszko R, Ramlau R, Cedres S, van Meerbeeck JP, Mencoboni M, Planchard D, Chella A, Crinò L, Krzakowski M, Rüssel J, Maconi A, Gianoncelli L, Grosso F. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019 Dec;20(12):1702-1709. doi: 10.1016/S1470-2045(19)30532-7. Epub 2019 Oct 15. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70.

lead_sponsor: NovoCure Ltd.

location_country: Poland Spain Italy Netherlands France Belgium Germany

location_facility: Klinika Nowotworów Pluca I Klatki Piersiowej

location_facility: Goustave Roussy - Cancer Campus Grand Paris

location_facility: Antwerp University Hospital, Thoracic Oncology

location_facility: Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu

location_facility: Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron

location_facility: A.S.O. "SS Antonio e Biagio e Cesare Arrigo"


acronym: Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALK

title: A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

ReferenceCitation: Fischer M, Moreno L, Ziegler DS, Marshall LV, Zwaan CM, Irwin MS, Casanova M, Sabado C, Wulff B, Stegert M, Wang L, Hurtado FK, Branle F, Geoerger B, Schulte JH. Ceritinib in paediatric patients with anaplastic lymphoma kinase-positive malignancies: an open-label, multicentre, phase 1, dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1764-1776. doi: 10.1016/S1470-2045(21)00536-2. Epub 2021 Nov 12.

ReferenceCitation: Brivio E, Zwaan CM. ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects. Pediatr Blood Cancer. 2019 May;66(5):e27645. doi: 10.1002/pbc.27645. Epub 2019 Jan 29.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Korea, Republic of
United States
France
Germany

location_facility: St Jude s Childrens Research Hospital Dept of Oncology

location_facility: Cincinnati Children s Hospital Medical Center Dept of Oncology

location_facility: Texas Children's Hospital Dept of Oncology

location_facility: Dana Farber Cancer Institute Dept of Onc

summary: The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.


title: A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

summary:
The primary objectives of the study are:

To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country:
Poland
Italy
Netherlands
Czech Republic
Ukraine
Hungary
France
Israel
Japan
Germany
Slovakia

location_facility:
Investigational Site
Investigational site


title: A Phase Ib/II Study of the ALK Inhibitor Ceritinib in Combination With the CDK4/6 Inhibitor LEE011 in Patients With ALK-positive Non-Small Cell Lung Cancer

summary:
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.

The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients.

This trial did not progress to Phase II. Trial population terminated before reaching Phase II

ipd_sharing: Undecided

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

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

location_country:
Taiwan
Spain
Italy
Korea, Republic of
United States
France


title: Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification

acronym: FICE;NICE

summary: The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.

status: Unknown status

ReferenceCitation: Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.

lead_sponsor: Istituto Clinico Humanitas

location_country:
United Kingdom
Italy
France
Belgium
Germany

location_facility: Endoscopy Unit, Humanitas Research Hospital

location_facility: Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder

location_facility: Dept of Gastroenterology and Endoscopy, University Hospital

location_facility: Department of Medicine I, University of Erlangen-Nürnberg Medical School

location_facility: Solent Centre for Digestive Diseases , Royal Alexandra Hospital

location_facility: Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon

location_facility: Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital


title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study

acronym: VENUS

summary: The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

ReferenceCitation: Shemesh M, Asher R, Zylberberg E, Guilak F, Linder-Ganz E, Elsner JJ. Viscoelastic properties of a synthetic meniscus implant. J Mech Behav Biomed Mater. 2014 Jan;29:42-55. doi: 10.1016/j.jmbbm.2013.08.021. Epub 2013 Sep 3.

ReferenceCitation: Zur G, Linder-Ganz E, Elsner JJ, Shani J, Brenner O, Agar G, Hershman EB, Arnoczky SP, Guilak F, Shterling A. Chondroprotective effects of a polycarbonate-urethane meniscal implant: histopathological results in a sheep model. Knee Surg Sports Traumatol Arthrosc. 2011 Feb;19(2):255-63. doi: 10.1007/s00167-010-1210-5. Epub 2010 Jul 16.

ReferenceCitation: Elsner JJ, Portnoy S, Guilak F, Shterling A, Linder-Ganz E. MRI-based characterization of bone anatomy in the human knee for size matching of a medial meniscal implant. J Biomech Eng. 2010 Oct;132(10):101008. doi: 10.1115/1.4002490.

ReferenceCitation: Elsner JJ, Portnoy S, Zur G, Guilak F, Shterling A, Linder-Ganz E. Design of a free-floating polycarbonate-urethane meniscal implant using finite element modeling and experimental validation. J Biomech Eng. 2010 Sep;132(9):095001. doi: 10.1115/1.4001892.

ReferenceCitation: Linder-Ganz E, Elsner JJ, Danino A, Guilak F, Shterling A. A novel quantitative approach for evaluating contact mechanics of meniscal replacements. J Biomech Eng. 2010 Feb;132(2):024501. doi: 10.1115/1.4000407.

ReferenceCitation: Elsner JJ, Shemesh M, Shefy-Peleg A, Gabet Y, Zylberberg E, Linder-Ganz E. Quantification of in vitro wear of a synthetic meniscus implant using gravimetric and micro-CT measurements. J Mech Behav Biomed Mater. 2015 Sep;49:310-20. doi: 10.1016/j.jmbbm.2015.05.017. Epub 2015 May 28.

ReferenceType: result

ReferenceCitation: De Coninck T, Elsner JJ, Linder-Ganz E, Cromheecke M, Shemesh M, Huysse W, Verdonk R, Verstraete K, Verdonk P. In-vivo evaluation of the kinematic behavior of an artificial medial meniscus implant: A pilot study using open-MRI. Clin Biomech (Bristol, Avon). 2014 Sep;29(8):898-905. doi: 10.1016/j.clinbiomech.2014.07.001. Epub 2014 Jul 17.

lead_sponsor: Active Implants

location_country: Italy Netherlands France Israel Belgium Germany

location_facility:
Assaf Harofeh Medical Center
Ichilov Hospital
AZ Monica
Academisch Ziekenhuis Maastricht
Centre Hospitalier de Versailles
Ospedale Sacro Cuore - Don Calabria
University Hospital of Munich


type: Other Grant/Funding Number

title: European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

acronym: ESPOIR

summary:
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
No additional diagnostic or monitoring procedures shall be applied to the patients
and epidemiological methods shall be used for the analysis of collected data.

Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

ReferenceCitation: Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hübler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.

ReferenceCitation: Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5). pii: ezac219. doi: 10.1093/ejcts/ezac219.

lead_sponsor: corlife

location_country:
United Kingdom
Italy
Netherlands
Switzerland
France
Belgium
Germany
Moldova, Republic of

location_facility: Great Ormond Street Hospital for Children NHS Trust, GOSH

location_facility: Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP

location_facility: Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU

location_facility: Leids Universitair Medisch Centrum, LUMC


title: A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

summary: The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.

ReferenceCitation: Yamamura T, Weinshenker B, Yeaman MR, De Seze J, Patti F, Lobo P, von Büdingen HC, Kou X, Weber K, Greenberg B. Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar. Mult Scler Relat Disord. 2022 Oct;66:104025. doi: 10.1016/j.msard.2022.104025. Epub 2022 Jul 5.

ReferenceCitation: Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, Tsai CP, Saiz A, Yamazaki H, Kawata Y, Wright P, De Seze J. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019 Nov 28;381(22):2114-2124. doi: 10.1056/NEJMoa1901747.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Ukraine
Hungary
United States
France
Japan
Germany

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: NeuroCure Clinical Research Center (NCRC)

location_facility: Great Ormand Street Hospital For Children; Neurology

location_facility: KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR

location_facility: Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Szpital Kliniczny im. H.Swiecickiego UM im.K.Marcinkowskiego

location_facility: Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

location_facility: National Taiwan University Hospital; Neurology

location_facility: Samodzielny Publiczny Centralny Szpital Klinicznyi

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Hopital de Hautepierre CHRU de Strasbourg

location_facility: University Hospital of Wales; Dept of Neurology

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: National Cheng Kung University Hospital; Neurology

location_facility: M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM

location_facility: Tokyo Women's Medical University Hospital; Neurology

location_facility: China Medical University Hospital; Neurology - Taichung

location_facility: Fukushima Medical University Hospital; Neurology

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology

location_facility: Niigata University Medical and Dental Hospital; Neurology


title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

summary: To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

ReferenceCitation: Farnier M, Jones P, Severance R, Averna M, Steinhagen-Thiessen E, Colhoun HM, Du Y, Hanotin C, Donahue S. Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial. Atherosclerosis. 2016 Jan;244:138-46. doi: 10.1016/j.atherosclerosis.2015.11.010. Epub 2015 Nov 14.

ReferenceCitation: Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Mexico
Germany

location_facility:
(2 Locations)
(3 Locations)


title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma

summary: First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Netherlands
United States
France

location_facility:
Research Site
Greenville Hospital System


title: Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

summary:
This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

ReferenceCitation: Mariani G, Dolce A, Batorova A, Auerswald G, Schved JF, Siragusa S, Napolitano M, Knudsen JB, Ingerslev J; STER and the International Factor VII Deficiency Study Groups. Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER. Br J Haematol. 2011 Feb;152(3):340-6. doi: 10.1111/j.1365-2141.2010.08287.x. Epub 2010 Dec 16.

ReferenceCitation: Mariani G, Dolce A, Napolitano M, Ingerslev J, Giansily-Blaizot M, Di Minno MD, Auerswald G, De Saez AR, Tagliaferri A, Batorova A; STER (Seven Treatment Evaluation Registry). Invasive procedures and minor surgery in factor VII deficiency. Haemophilia. 2012 May;18(3):e63-5. doi: 10.1111/j.1365-2516.2012.02751.x. Epub 2012 Feb 22.

lead_sponsor: Novo Nordisk A/S

location_country:
Hong Kong
Serbia
Spain
Greece
Italy
Iran, Islamic Republic of
Thailand
Venezuela
United States
France
India
Israel
Turkey
Germany
Pakistan
Slovakia


title: Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

summary: PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

ReferenceCitation: De Greef Y, Dekker L, Boersma L, Murray S, Wieczorek M, Spitzer SG, Davidson N, Furniss S, Hocini M, Geller JC, Csanádi Z; PRECISION GOLD investigators. Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial. Europace. 2016 May;18(5):687-95. doi: 10.1093/europace/euv385. Epub 2016 Jan 29.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United Kingdom
Netherlands
Hungary
France
Belgium
Germany

location_facility: Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR


title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation

acronym: KONTINUE

summary: The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

ReferenceCitation: Pilewski JM, De Boeck K, Nick JA, Tian S, DeSouza C, Higgins M, Moss RB. Long-Term Ivacaftor in People Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations. Pulm Ther. 2020 Dec;6(2):303-313. doi: 10.1007/s41030-020-00129-2. Epub 2020 Sep 23.

ReferenceCitation: Moss RB, Flume PA, Elborn JS, Cooke J, Rowe SM, McColley SA, Rubenstein RC, Higgins M; VX11-770-110 (KONDUCT) Study Group. Efficacy and safety of ivacaftor in patients with cystic fibrosis who have an Arg117His-CFTR mutation: a double-blind, randomised controlled trial. Lancet Respir Med. 2015 Jul;3(7):524-33. doi: 10.1016/S2213-2600(15)00201-5. Epub 2015 Jun 9.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United States
France
United Kingdom
Belgium


title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

summary: The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

ReferenceCitation: Azaro A, Baldini C, Rodon J, Soria JC, Yuen E, Lithio A, Oakley G, Benhadji KA, Massard C. Phase 1 study of 2 high dose intensity schedules of the pan-Notch inhibitor crenigacestat (LY3039478) in combination with prednisone in patients with advanced or metastatic cancer. Invest New Drugs. 2021 Feb;39(1):193-201. doi: 10.1007/s10637-020-00944-z. Epub 2020 Sep 11.

ReferenceCitation: Mir O, Azaro A, Merchan J, Chugh R, Trent J, Rodon J, Ohnmacht U, Diener JT, Smith C, Yuen E, Oakley GJ 3rd, Le Cesne A, Soria JC, Benhadji KA, Massard C. Notch pathway inhibition with LY3039478 in soft tissue sarcoma and gastrointestinal stromal tumours. Eur J Cancer. 2018 Nov;103:88-97. doi: 10.1016/j.ejca.2018.08.012. Epub 2018 Sep 12.

ReferenceCitation: Massard C, Azaro A, Soria JC, Lassen U, Le Tourneau C, Sarker D, Smith C, Ohnmacht U, Oakley G, Patel BKR, Yuen ESM, Benhadji KA, Rodon J. First-in-human study of LY3039478, an oral Notch signaling inhibitor in advanced or metastatic cancer. Ann Oncol. 2018 Sep 1;29(9):1911-1917. doi: 10.1093/annonc/mdy244.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Spain
United Kingdom
United States
France
Germany

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


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

ReferenceCitation: Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

ReferenceCitation: Sheth S, Gao C, Mueller N, Angra N, Gupta A, Germa C, Martinez P, Soria JC. Durvalumab activity in previously treated patients who stopped durvalumab without disease progression. J Immunother Cancer. 2020 Aug;8(2). pii: e000650. doi: 10.1136/jitc-2020-000650.

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

ReferenceCitation: Zajac M, Ye J, Mukhopadhyay P, Jin X, Ben Y, Antal J, Gupta AK, Rebelatto MC, Williams JA, Walker J. Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy. PLoS One. 2020 Apr 27;15(4):e0231936. doi: 10.1371/journal.pone.0231936. eCollection 2020.

ReferenceCitation: Nordstrom BL, Oguz M, Chu BC, Ouwens M, Arkenau HT, Klein AB. Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison. J Comp Eff Res. 2020 Feb;9(3):191-199. doi: 10.2217/cer-2019-0163. Epub 2020 Jan 9.

ReferenceCitation: Antonia SJ, Balmanoukian A, Brahmer J, Ou SI, Hellmann MD, Kim SW, Ahn MJ, Kim DW, Gutierrez M, Liu SV, Schöffski P, Jäger D, Jamal R, Jerusalem G, Lutzky J, Nemunaitis J, Calabrò L, Weiss J, Gadgeel S, Bhosle J, Ascierto PA, Rebelatto MC, Narwal R, Liang M, Xiao F, Antal J, Abdullah S, Angra N, Gupta AK, Khleif SN, Segal NH. Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC. J Thorac Oncol. 2019 Oct;14(10):1794-1806. doi: 10.1016/j.jtho.2019.06.010. Epub 2019 Jun 20.

ReferenceCitation: Althammer S, Tan TH, Spitzmüller A, Rognoni L, Wiestler T, Herz T, Widmaier M, Rebelatto MC, Kaplon H, Damotte D, Alifano M, Hammond SA, Dieu-Nosjean MC, Ranade K, Schmidt G, Higgs BW, Steele KE. Automated image analysis of NSCLC biopsies to predict response to anti-PD-L1 therapy. J Immunother Cancer. 2019 May 6;7(1):121. doi: 10.1186/s40425-019-0589-x.

ReferenceCitation: Segal NH, Ou SI, Balmanoukian A, Fury MG, Massarelli E, Brahmer JR, Weiss J, Schöffski P, Antonia SJ, Massard C, Zandberg DP, Khleif SN, Xiao F, Rebelatto MC, Steele KE, Robbins PB, Angra N, Song X, Abdullah S, Butler M. Safety and efficacy of durvalumab in patients with head and neck squamous cell carcinoma: results from a phase I/II expansion cohort. Eur J Cancer. 2019 Mar;109:154-161. doi: 10.1016/j.ejca.2018.12.029. Epub 2019 Feb 4.

ReferenceCitation: Zajac M, Boothman AM, Ben Y, Gupta A, Jin X, Mistry A, Sabalos C, Nielsen A, Manriquez G, Barker C, Antal J, Wang P, Patil P, Schechter N, Rebelatto MC, Walker J. Analytical Validation and Clinical Utility of an Immunohistochemical Programmed Death Ligand-1 Diagnostic Assay and Combined Tumor and Immune Cell Scoring Algorithm for Durvalumab in Urothelial Carcinoma. Arch Pathol Lab Med. 2019 Jun;143(6):722-731. doi: 10.5858/arpa.2017-0555-OA. Epub 2018 Nov 20.

ReferenceCitation: Steele KE, Tan TH, Korn R, Dacosta K, Brown C, Kuziora M, Zimmermann J, Laffin B, Widmaier M, Rognoni L, Cardenes R, Schneider K, Boutrin A, Martin P, Zha J, Wiestler T. Measuring multiple parameters of CD8+ tumor-infiltrating lymphocytes in human cancers by image analysis. J Immunother Cancer. 2018 Mar 6;6(1):20. doi: 10.1186/s40425-018-0326-x.

ReferenceCitation: Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, Lee JL, Ong M, Sridhar SS, Vogelzang NJ, Fishman MN, Zhang J, Srinivas S, Parikh J, Antal J, Jin X, Gupta AK, Ben Y, Hahn NM. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. doi: 10.1001/jamaoncol.2017.2411. Epub 2017 Sep 14.

ReferenceCitation: Levy A, Massard C, Soria JC, Deutsch E. Concurrent irradiation with the anti-programmed cell death ligand-1 immune checkpoint blocker durvalumab: Single centre subset analysis from a phase 1/2 trial. Eur J Cancer. 2016 Nov;68:156-162. doi: 10.1016/j.ejca.2016.09.013. Epub 2016 Oct 17.

lead_sponsor: MedImmune LLC

location_country:
Taiwan
United Kingdom
Italy
Canada
Korea, Republic of
United States
France
Belgium
Germany


acronym: Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric Glaucoma

title: A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma

lead_sponsor: Allergan

location_country:
Taiwan
United Kingdom
Italy
Korea, Republic of
United States
France
Philippines

summary: The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.


primary_purpose: Prevention

acronym: OPTION

title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients

lead_sponsor: Astellas Pharma Europe Ltd.

ReferenceCitation: Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Poland
Spain
United Kingdom
France
Belgium
Germany

location_facility:
Site 40
Site 13
Site 10
Site: 60
Site 20
Site 21
Site 30
Site 50
Site 31
Site 22

summary: The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.


title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.

ReferenceCitation: Crinò L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.

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

location_facility: Massachusetts General Hospital Mass General

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Kansas Cancer Center DeptofUofKansas CancerCenter-2

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept of Oncology

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: City of Hope National Medical Center Dept of Oncology 2

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: University of California at Los Angeles Reg-5

location_facility: Stanford University Medical Center Stanford Cancer Center(2)

summary: A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator


title: BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

summary: This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

ReferenceCitation: Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN β-1b in multiple sclerosis--results of the βPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

lead_sponsor: Bayer

location_country:
Taiwan
Portugal
Jordan
Saudi Arabia
Italy
Spain
Iran, Islamic Republic of
Lebanon
Netherlands
Czech Republic
Korea, Republic of
France
Israel
Turkey
Germany


title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

acronym: VANTAGE

summary: The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

ReferenceCitation: Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brücke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Vérin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Italy
Austria
United Kingdom
France
Germany

location_facility:
CHU de Rennes-Pontchaillou
Hospital Central de Asturias
Allgemeines Krankenhaus AKH
IRCCS Istituto Ortopedico Galeazzi
Uniklinik Köln
Southmead Hospital Bristol
Frenchay Hospital


title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

acronym: eMESH 1

summary: Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

lead_sponsor: Kips Bay Medical, Inc.

location_country:
United Kingdom
Italy
Czech Republic
Switzerland
United States
France
Netherlands

location_facility: Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research


title: A Randomised Double-blind Study to Compare the Analgesic Efficacy and Safety Profiles of M6G and Morphine, as a Loading Dose Followed by PCA, in Patients Suffering Moderate to Severe Post-operative Pain Requiring PCA for at Least 24 Hours

summary: To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

lead_sponsor: Paion UK Ltd.

location_country:
Poland
United Kingdom
Netherlands
Czech Republic
France
Germany

location_facility: Intensive Care Unit, Level 5, Western Infirmary,

location_facility: Anaesthetisia - Resuscitation Department, Tenon Hospital

location_facility: Teaching Hospital Bulovka, Department of Urology

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik f. Anaesthesiologie

location_facility: Department of Anaesthesiology, Leiden University Medical Centre


title: Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

ReferenceCitation: Cristy M, Eckerman KF. 1987. Specific absorbed fractions of energy at various ages from internal sources: I. methods. Prepared by the Oak Ridge National Laboratory, Oak Ridge, Tenn.

ReferenceCitation: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55.

ReferenceCitation: Vermorken JB, Licitra L, Stöhlmacher-Williams J, Dietz A, Lopez-Picazo JM, Hamid O, Hossain AM, Chang SC, Gauler TC. Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Sep;49(13):2877-83. doi: 10.1016/j.ejca.2013.05.002. Epub 2013 May 30.

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

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


title: A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

summary: The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

ReferenceCitation: Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

lead_sponsor: Aeris Therapeutics

location_country: Austria Germany France Israel

location_facility: Otto Wagner Spital Wien Interne Lungenabteilung

location_facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

location_facility: Medizinische Klinik und Poliklinik Klinikum Großhadern

location_facility: Rabin Medical Center, Beilinson Hospital


title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) in the Treatment of Infants 0 to <12 Months of Age With Confirmed Influenza Infection

ReferenceCitation: Rath BA, Brzostek J, Guillén S, Niranjan V, Chappey C, Rayner CR, Clinch B. Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multicentre clinical trial. Antivir Ther. 2015;20(8):815-25. doi: 10.3851/IMP2967. Epub 2015 May 27.

location_country: Poland Spain Italy France Belgium Germany

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Hospital Universitario de Getafe; Servicio de Pediatria

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: CAMPUS VIRCHOW-KLINIKUM CharitéCentrum 17 Klinik f.Pädiatrie Abt.Pneumologie u.Immunologie

location_facility: Zespol Opieki Zdrowotnej Debica; Oddzial Dzieciecy

location_facility: Onkologische Schwerpunktpraxis Dr. Med. O. Burkhard & B. Reimann

location_facility: Samodzielny Publiczny Zakład Opieki; Wcześniaków I Intensywnej Terapii

location_facility: Hôpital Femme Mère Enfant; Service de rhumatologie pédiatrique

summary: This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.


title: CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

summary:
The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.

As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

ReferenceCitation: Kuzman I, Bezlepko A, Kondova Topuzovska I, Rókusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.

location_country: Macedonia, The Former Yugoslav Republic of


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)

acronym: FUSCIA

summary:
Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

lead_sponsor: Sanofi

location_country:
Poland
Italy
Austria
Canada
United States
France
Germany

location_facility:
Investigational Site Number 616008
Investigational Site Number 840071
Investigational Site Number 250003
Investigational Site Number 840059
Investigational Site Number 840001
Investigational Site Number 840048
Investigational Site Number 840019
Investigational Site Number 040003
Investigational Site Number 840070
Investigational Site Number 616002
Investigational Site Number 840008
Investigational Site Number 840061
Investigational Site Number 840088
Investigational Site Number 380006
Investigational Site Number 616001
Investigational Site Number 380003
Investigational Site Number 840051
Investigational Site Number 840034
Investigational Site Number 840053
Investigational Site Number 276007
Investigational Site Number 840060
Investigational Site Number 250006
Investigational Site Number 840038
Investigational Site Number 276005
Investigational Site Number 840064
Investigational Site Number 616004
Investigational Site Number 616005
Investigational Site Number 616006
Investigational Site Number 840074
Investigational Site Number 840024
Investigational Site Number 840068
Investigational Site Number 840089
Investigational Site Number 616007
Investigational Site Number 840045
Investigational Site Number 840046
Investigational Site Number 840065
Investigational Site Number 124002
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840078


acronym: DIONE

title: A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Spain
Ireland
United Kingdom
Ukraine
United States
France

summary: The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to <18 years and weighing at least 40 kg.


title: An Open-label, Multicenter, Single-arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects With Epilepsy Switching From Levetiracetam to Brivaracetam Due to Nonpsychotic Behavioral Side Effects Phase 3b

summary: Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

ReferenceCitation: Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D'Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015 Nov;52(Pt A):165-8. doi: 10.1016/j.yebeh.2015.09.005. Epub 2015 Sep 29.

lead_sponsor: UCB Pharma SA

location_country:
United Kingdom
Spain
United States
France
Germany


title: A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

summary: This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

ReferenceCitation: Lüscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Münzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

ReferenceCitation: Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Münzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Lüscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6.

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Italy
Austria
Netherlands
Switzerland
France
Germany