title: Evaluation de l'intérêt d'une préparation de l'intestin Grèle par polyéthylèneglycol pour l'exploration par vidéocapsule endoscopique des saignements digestifs inexpliqués

acronym: PREPINTEST

lead_sponsor: CHRU de BREST


title:
CrYSTobs  A cohort of patients with cystinosis : compliance to cysteamine and neurological complications
 An auxiliary study to Raptor RP103 03 and RP103 04

acronym: CrYSTobs

source: euctr

lead_sponsor: HOSPICES CIVILS DE LYON

study_type: Interventional

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title: A multicentre phase II trial to determine the efficacy of RAD 001 (everolimus, Afinitor®) as second line therapy in patients with transitional cell carcinoma (TCC) of the urothelium which failed or progressed after first line chemotherapy.

acronym: AFINIVEST

lead_sponsor: Hôpital FOCH

status: Completed

status_simplified: Completed


title: EXPAND ID. Analyse de la réponse immunitaire à la vaccination anti-grippe chez les sujets âgés de 65 ans et plus.

acronym: EXPAND ID

lead_sponsor: Hospices Civils de Lyon


title: Pharmacocinétique de population des anti-infectieux (Ceftazidime, Ciprofloxacine et Voriconazole) chez l’enfant âgé de 1 mois à 5 ans.

acronym: PHARM-A

lead_sponsor: CHU de BORDEAUX

status_simplified: Unknown


title: Dyva-AAGG: Dysfonction vasculaire micro et macro vasculaire induite par les traitements anti-angiogéniques : Identification de nouveaux marqueurs pronostics

acronym: DYVA-AAGG

lead_sponsor: CHU Angers


title:
Population pharmacokinetics of levofloxacin in intensive care patients with severe community-acquired pneumonia

 Pharmacocinétique de population de la lévofloxacine chez des patients de réanimation présentant une pneumopathie communautaire

acronym: Lévo-Pharm

lead_sponsor: CHU de Toulouse


title:
Efficacy and safety of acebutolol versus propranolol in the proliferative phase of infantile hemangiomas

 Efficacité et tolérance de l'acébutolol versus propranolol sur la phase proliférative des  hémangiomes infantiles

lead_sponsor: UH Montpellier

lead_sponsor_type: industriel


title:
Patient pREference and satisFaction for pErindopril oRodispersible vs convENtional tablets in daily Clinical practicE
 PREFERENCE
 Étude clinique interventionnelle, menée en ouvert et en consultation de médecine générale

lead_sponsor: Servier International / Les Laboratoires Servier


title: Evaluation de l’efficacité et de la tolérance de deux vasopresseurs dans le traitement des hypotensions artérielles per-opératoires en chirurgie carotidienne : étude prospective randomisée contrôlée monocentrique.

acronym: VP-hTA-XCar

lead_sponsor: CHU de Clermont-Ferrand


title:
Evaluation of the effectiveness of intradiscal injection of corticosteroids in the Modic I discopathies

 Evaluation de l'efficacité d'une injection intradiscale de corticoïdes dans les discopathies Modic I


title:
MEOPA (equimolar mixture of oxygen and protoxide of nitrogen) versus local anesthetic for analgesia during the biopsy of trophoblast.

 MEOPA (mélange équimolaire d'oxygène et de protoxyde d'azote) versus anesthésie locale pour l'analgésie lors de la biopsie de trophoblaste.

acronym:
MELIBIO

 MELIBIO

lead_sponsor: HOPITAL SAINT JOSEPH


title:
Randomized prospective clinical study evaluating the usefulness of fibrin glue (TISSEEL) to prevent gastric fistula, intra abdominal haemorrhage and intra abdominal loco regional collections after Laparoscopic sleeve Gastrectomy

 Etude prospective, randomisée, évaluant l’intérêt de l’utilisation de colle biologique (TISSEEL) dans la prévention des complications après gastrectomie longitudinale

acronym:
tisseel

 tisseel

lead_sponsor: CHU AMIENS


title: Secured access to vemurafenib for patients with tumors harboring BRAF genomic alterations.

acronym: AcSé Vemurafenib

lead_sponsor: UNICANCER


title: Non-randomised Open Label Pilot Study of Sirolimus Therapy for Segmental Overgrowth Due to PIK3CA- Related Overgrowth

acronym: PROMISE

lead_sponsor: CHU de DIJON


title:
N/A

 Etude pilote, comparative, monocentrique, randomisée, en cross over, en double aveugle, contre placebo, testant l'efficacité de l'huile de triheptanoïne dans les Hémiplégies Alternantes de l'Enfant

acronym: HEMIHEP

lead_sponsor: Inserm


title:
Sampling Antibiotics in Renal Replacement Therapy: the AZUREA contribution

 Taux plasmatiques d’antibiotiques pendant un traitement de suppléance rénale chez les patients de réanimation: la contribution du groupe AZUREA

acronym: SMARRT

lead_sponsor: CHU de NIMES

status: Prematurely Ended


title:
Efficacy and safety assessment of intracameral T2380 (Fixed combination of lidocaïne, phenylephrine and tropicamide) to obtain mydriasis in patients with small pupils for cataract surgery by phacoemulsification
 Phase II pilot open study, monocentric, with 40 patients

lead_sponsor: Laboratoires Théa


title:
Study of the effect of oxytocin on emotion regulation in adolescents with insecure attachment

 Etude de l'effet de l'ocytocine sur la régulation émotionnelle chez des adolescents à l’attachement insécure

acronym:
ELOREA

 ELOREA

lead_sponsor: Centre Hospitalier Régional Universitaire de Besancon


title:
EPAG 2015 : A phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with acute myeloid leukemia receiving induction chemotherapy

 EPAG 2015 "Etude de phase II randomisée versus placebo de l'impact sur le devenir de l'administration d'Eltrombopag à des patients agés atteints d'une Leucemie Aigue Myeloblastique qui recoivent une chimiotherapie d'induction."

lead_sponsor: GOELAMS


title:
Safety profile evaluation of TICagrelor Alone compared to a combination of lysine acetylsalicylate - Clopidogrel in the context of Transcatheter Aortic Valve Implantation (TAVI)

 Evaluation du profil de sécurité du TICagrelor utilisé seul en comparaison avec une association acétylsalicylate de lysine-clopidogrel dans le contexte de l’implantation de valve aortique percutanée  (TAVI)

acronym:
TICTAVI

 TICTAVI

lead_sponsor: CHU de Bordeaux


title: Effectiveness of nebulization by high nasal flow during acute respiratory decompensations of chronic respiratory insufficiency.

lead_sponsor: CHU DE POITIERS


title:
The efficacy of traumatic memory modification using a memory reconsolidation procedure under propranolol among adolescents with post-traumatic stress disorder (PROPRADO)

 Impact d’une procédure de reconsolidation de la mémoire sous PROPRanolol sur la mémoire traumatique des ADOlescents atteints du syndrome de stress post-traumatique (PROPRADO)

acronym:
PROPRADO

 PROPRADO

lead_sponsor: Rennes University Hospital


title:
The NIPA study: A randomized double-blind control clinical trial Naloxegol administration to prevent opioids induced gastrointestinal motility disturbance in brain Injured PAtients.

 Etude NIPA : Essai contrôlé randomisé en double aveugle évaluant l’administration prophylactique de Naloxegol pour prévenir les troubles de la motilité gastro-intestinale induits par les opioïdes chez les patients cérébrolésés.

acronym:
NIPA

 NIPA

lead_sponsor: CHRU de Brest


title: Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Hospitalized Subjects With Pneumonia Requiring Mechanical Ventilation

summary: The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. doi: 10.1164/ajrccm.153.5.8630626. No abstract available.

ReferenceCitation: Bauernfeind A, Jungwirth R. In Vitro Activity of SM 7338 and Imipenem. 28th ICAAC, Los Angeles, October 1988. Abstract 599

ReferenceCitation: Calandra GB, Hesney M, Brown KR. Imipenem/cilastatin therapy of serious infections: a U.S. multicenter noncomparative trial. Clin Ther. 1985;7(2):225-38.

ReferenceCitation: Clarke AM, Zemcov SJV. SM 7338 (ICI 194,660), A New DHP-1 Stable Carbapenem; In Vitro Activity Against a Wide Range of Canadian Clinical Isolates. 28th ICAAC, Los Angeles, October 1988. Abstract 598.

ReferenceCitation: Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284.

ReferenceCitation: Craig WA. The pharmacology of meropenem, a new carbapenem antibiotic. Clin Infect Dis. 1997 Feb;24 Suppl 2:S266-75. doi: 10.1093/clinids/24.supplement_2.s266.

ReferenceCitation: Dandekar PK, Maglio D, Sutherland CA, Nightingale CH, Nicolau DP. Pharmacokinetics of meropenem 0.5 and 2 g every 8 hours as a 3-hour infusion. Pharmacotherapy. 2003 Aug;23(8):988-91. doi: 10.1592/phco.23.8.988.32878.

ReferenceCitation: Data on file. Drug Development Department, AstraZeneca Pharmaceuticals, Wilmington,DE 19897.

ReferenceCitation: Drusano GL. Prevention of resistance: a goal for dose selection for antimicrobial agents. Clin Infect Dis. 2003 Jan 15;36(Suppl 1):S42-50. doi: 10.1086/344653.

ReferenceCitation: Drusano GL, Liu W, Fregeau C, Kulawy R, Louie A. Differing effects of combination chemotherapy with meropenem and tobramycin on cell kill and suppression of resistance of wild-type Pseudomonas aeruginosa PAO1 and its isogenic MexAB efflux pump-overexpressed mutant. Antimicrob Agents Chemother. 2009 Jun;53(6):2266-73. doi: 10.1128/AAC.01680-08. Epub 2009 Mar 16.

ReferenceCitation: Edwards JR, Wannop C. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against Imipenem-Resistant Ps. aeruginosa. 27th ICAAC, New York October 1987, Abstract 754.

ReferenceCitation: Edwards JR, Turner PJ, Withnell ES, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against Bacterial Strains of Clinical Origins. 27th ICAAC, New York, October 1987, Abstract 755.

ReferenceCitation: Edwards JR, Turner PJ, Wannop C, Withnell ES, Grindey AJ, Nairn K. In vitro antibacterial activity of SM-7338, a carbapenem antibiotic with stability to dehydropeptidase I. Antimicrob Agents Chemother. 1989 Feb;33(2):215-22. doi: 10.1128/AAC.33.2.215.

ReferenceCitation: Fagon JY, Chastre J, Novara A, Medioni P, Gibert C. Characterization of intensive care unit patients using a model based on the presence or absence of organ dysfunctions and/or infection: the ODIN model. Intensive Care Med. 1993;19(3):137-44. doi: 10.1007/BF01720528.

ReferenceCitation: Fink MP, Snydman DR, Niederman MS, Leeper KV Jr, Johnson RH, Heard SO, Wunderink RG, Caldwell JW, Schentag JJ, Siami GA, et al. Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group. Antimicrob Agents Chemother. 1994 Mar;38(3):547-57. doi: 10.1128/AAC.38.3.547.

ReferenceCitation: Fukasawa M, Sumita Y, Tada E, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against 1607 Clinical Strains of Gram-Positive and Gram-Negative Pathogens. 27th ICAAC, New York, October 1987, Abstract 753.

ReferenceCitation: Fukasawa M, Tada E, Nouda H, et al. Induction and Inhibition of b-Lactamases by SM 7338; A Novel Carbapenem Antibacterial. 28th ICAAC, Los Angeles, October 1988. Abstract 606.

ReferenceCitation: Hamacher J, Vogel F, Lichey J, Kohl FV, Diwok K, Wendel H, Lode H. Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease in hospitalised patients--a comparison of meropenem and imipenem/cilastatin. COPD Study Group. J Antimicrob Chemother. 1995 Jul;36 Suppl A:121-33. doi: 10.1093/jac/36.suppl_a.121.

ReferenceCitation: Heyland DK, Cook DJ, Griffith L, Keenan SP, Brun-Buisson C. The attributable morbidity and mortality of ventilator-associated pneumonia in the critically ill patient. The Canadian Critical Trials Group. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1249-56. doi: 10.1164/ajrccm.159.4.9807050.

ReferenceCitation: Investigational Brochure, Drug Development Department, AstraZeneca Pharmaceuticals, Wilmington, Delaware 19897.

ReferenceCitation: Jones RN, Barry AL, et al. Antimicrobial Activity of SM 7338, A New DHP-1 Stable Carbapenem. 28th ICAAC, Los Angeles, October 1988. Abstract 597.

ReferenceCitation: Kayser FH, Morenzoni G. Activity of SM 7338, A New Carbapenem Antibacterial Against Gram-Positive Bacteria. 28th ICAAC, Los Angeles, October 1988. Abstract 603.

ReferenceCitation: Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74. doi: 10.1378/chest.115.2.462.

ReferenceCitation: Kollef MH, Silver P, Murphy DM, Trovillion E. The effect of late-onset ventilator-associated pneumonia in determining patient mortality. Chest. 1995 Dec;108(6):1655-62. doi: 10.1378/chest.108.6.1655.

ReferenceCitation: Lancero MG, Young LS. In Vitro Studies with SM 7338; A Novel Carbapenem with Broad Bactericidal Activity. 28th ICAAC, Los Angeles, October 1988. Abstract 602.

ReferenceCitation: Lode H, Hamacher J, Eller J, Schaberg T. Changing role of carbapenems in the treatment of lower respiratory tract infections. Scand J Infect Dis Suppl. 1995;96:17-23.

ReferenceCitation: Luna CM, Vujacich P, Niederman MS, Vay C, Gherardi C, Matera J, Jolly EC. Impact of BAL data on the therapy and outcome of ventilator-associated pneumonia. Chest. 1997 Mar;111(3):676-85. doi: 10.1378/chest.111.3.676.

ReferenceCitation: McEachern R, Campbell GD Jr. Hospital-acquired pneumonia: epidemiology, etiology, and treatment. Infect Dis Clin North Am. 1998 Sep;12(3):761-79, x. doi: 10.1016/s0891-5520(05)70209-9.

ReferenceCitation: Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. doi: 10.1378/chest.102.5_supplement_1.557s. No abstract available.

ReferenceCitation: Moellering RC Jr, Eliopoulos GM, Sentochnik DE. The carbapenems: new broad spectrum beta-lactam antibiotics. J Antimicrob Chemother. 1989 Sep;24 Suppl A:1-7. doi: 10.1093/jac/24.suppl_a.1.

ReferenceCitation: Neu HG, Saha G, Chin NX. In Vitro Activity of SM 7338; A New Carbapenem, Compared with Other Antibacterials Against Multiply Resistant Bacteria. 28th ICAAC, Los Angeles, October 1988. Abstract 601.

ReferenceCitation: Nord CE, Lindmark A, Persson I. Susceptibility of Anaerobic Bacteria to SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 596.

ReferenceCitation: Okuda T, Fukasawa M, Tanio T, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro and In Vivo Antibacterial Activities. 27th ICAAC, New York, October 1987. Abstract 757.

ReferenceCitation: Quinn JP, Studemeister AE, DiVincenzo CA, Lerner SA. Resistance to imipenem in Pseudomonas aeruginosa: clinical experience and biochemical mechanisms. Rev Infect Dis. 1988 Jul-Aug;10(4):892-8. doi: 10.1093/clinids/10.4.892.

ReferenceCitation: Sanford Guide to Antimicrobial Therapy. Thirty-third Edition, 2003. Gilbert DN, Moellering RC, Sande MA.

ReferenceCitation: Scheld WM, Mandell GL. Nosocomial pneumonia: pathogenesis and recent advances in diagnosis and therapy. Rev Infect Dis. 1991 Jul-Aug;13 Suppl 9:S743-51. doi: 10.1093/clinids/13.supplement_9.s743.

ReferenceCitation: Slaney L, Chubb H, Mohammed Z, et al. In Vitro Activity of SM 7338 Against Neisseria gonorrhoeae (Gc), Haemophilus ducreyi (Hd) and Haemophilus influenzae. 28th ICAAC, Los Angeles, October 1988. Abstract 604.

ReferenceCitation: Strasbaugh LJ. Nosocomial repiratory infections. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and practice of infectious disease. Philadelphia: Churchill Livingstone, 2000: 3021-3026.

ReferenceCitation: Sumita Y, Fukasawa M, Okunda T. SM 7338, A New Carbapenem Antibacterial: Affinities for PBP's and Morphological Changes. 27th ICAAC, New York, October 1987. Abstract 756.

ReferenceCitation: Sumita Y, Inoue M, Mitsuhashi S. In Vitro Antibacterial Activity of SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 600.

ReferenceCitation: Sunagawa M, Matsumura H, Inoue T, et al. SM 7338, A New Carbapenem Antibacterial: Structure-Activity Relations and Physiochemical Properties. 27th ICAAC, New York, October 1987. Abstract 752.

ReferenceCitation: TALKE H, SCHUBERT GE. [ENZYMATIC UREA DETERMINATION IN THE BLOOD AND SERUM IN THE WARBURG OPTICAL TEST]. Klin Wochenschr. 1965 Feb 1;43:174-5. doi: 10.1007/BF01484513. No abstract available. German.

ReferenceCitation: Torres A, Aznar R, Gatell JM, Jimenez P, Gonzalez J, Ferrer A, Celis R, Rodriguez-Roisin R. Incidence, risk, and prognosis factors of nosocomial pneumonia in mechanically ventilated patients. Am Rev Respir Dis. 1990 Sep;142(3):523-8. doi: 10.1164/ajrccm/142.3.523.

ReferenceCitation: Torres A, Bauer TT, Leon-Gil C, Castillo F, Alvarez-Lerma F, Martinez-Pellus A, Leal-Noval SR, Nadal P, Palomar M, Blanquer J, Ros F. Treatment of severe nosocomial pneumonia: a prospective randomised comparison of intravenous ciprofloxacin with imipenem/cilastatin. Thorax. 2000 Dec;55(12):1033-9. doi: 10.1136/thorax.55.12.1033.

ReferenceCitation: Trouillet JL, Chastre J, Vuagnat A, Joly-Guillou ML, Combaux D, Dombret MC, Gibert C. Ventilator-associated pneumonia caused by potentially drug-resistant bacteria. Am J Respir Crit Care Med. 1998 Feb;157(2):531-9. doi: 10.1164/ajrccm.157.2.9705064.

ReferenceCitation: Vetter N. The Use of Meropenem ('Merrem'/'Meronen') in the Therapy of Hospital-acquired Lower Respiratory Infections: a Review of Clinical Experience. 18th International Congress of Chemotherapy, Stockholm, Sweden, 27 June-2 July, 1993. Abstract 70.

ReferenceCitation: Wise R, Andrews JM, Ashby JP. The Bactericidal Activity of the Carbapenem, SM 7338, Alone and in Combination. 28th ICAAC, Los Angeles, October 1988. Abstract 605.

ReferenceCitation: World Health Organization. Draft Global Strategy for the Containment of Antimicrobial Resistance. Available on the Internet at http://www.who.int/emc/amr.htm

ReferenceType: derived

ReferenceCitation: Drusano GL, Corrado ML, Girardi G, Ellis-Grosse EJ, Wunderink RG, Donnelly H, Leeper KV, Brown M, Malek T, Hite RD, Ferrari M, Djureinovic D, Kollef MH, Mayfield L, Doyle A, Chastre J, Combes A, Walsh TJ, Dorizas K, Alnuaimat H, Morgan BE, Rello J, Mazo CA, Jones RN, Flamm RK, Woosley L, Ambrose PG, Bhavnani S, Rubino CM, Bulik CC, Louie A, Vicchiarelli M, Berman C. Dilution Factor of Quantitative Bacterial Cultures Obtained by Bronchoalveolar Lavage in Patients with Ventilator-Associated Bacterial Pneumonia. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01323-17. doi: 10.1128/AAC.01323-17. Print 2018 Jan. Erratum In: Antimicrob Agents Chemother. 2018 Mar 27;62(4):

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology

ipd_sharing: No

lead_sponsor: University of Florida

location_country:
United States
Spain
Germany
France

location_facility: UFL Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

location_facility: Institut de Cardiologie, Groupe Hospitalier Pitie-Salpetriere

location_facility: Cleveland Clinic Lerner College of Medicine

location_facility: Washington University in St. Louis School of Medicine

location_facility: Weill Cornell Medical Center of Cornell University

intervention_type: Drug


title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

summary: This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

ReferenceType: result

ReferenceCitation: Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl. 2005 Aug;11(8):973-9. doi: 10.1002/lt.20470.

ReferenceCitation: Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
United Kingdom
Australia
Sweden
Spain
Canada
France


title: International Retrospective Study of Pipeline Embolization Device

acronym: IntrePED

summary:
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals.

Data collection will be initiated starting March 2012 and continue until approximately April 2017.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Park MS, Kilburg C, Taussky P, Albuquerque FC, Kallmes DF, Levy EI, Jabbour P, Szikora I, Boccardi E, Hanel RA, Bonafe A, McDougall CG. Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry. AJNR Am J Neuroradiol. 2016 Jun;37(6):1127-31. doi: 10.3174/ajnr.A4678. Epub 2016 Jan 14.

oa_colors: green hybrid

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Neuroradiology (ASNR)

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Italy
Hungary
Argentina
United States
Canada
France

location_facility: Fort Sanders Regional Medical Center, Neurovascular Research

location_facility: University of Buffalo Neurosurgery, Buffalo General Hospital


title: A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis

summary:
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months.

Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

study_start_date_type: Actual

ReferenceCitation: Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.

oa_host_type: repository

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: Erasmus University Rotterdam - EUR Research Repository

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
India
Hong Kong
Australia
Sweden
Netherlands
Austria
Belgium
Canada
France

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Policlinico Universitario Agostino Gemelli

intervention_type: Device


title: A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

summary: The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Zimmer Biomet

location_country:
Germany
Italy
United Kingdom
Denmark
Belgium
United States
Spain
France

location_facility: OrthoVirginia West End Orthopedic Clinic

location_facility: Klinik fur Endoprothetik und gelenkchirurgie

location_facility: Azienda Ospedaliero Universitaria Pisana


type: Other Identifier

title: WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol

summary: This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

ReferenceCitation: Juliao P, Wurst K, Pimenta JM, Gemzoe K, Landy H, Moody MA, Tilson H, Covington D, Moore T, Marino R, Gilbride J, Liu A, Meizlik P, Petri M. Belimumab use during pregnancy: Interim results of the belimumab pregnancy registry. Birth Defects Res. 2023 Jan 15;115(2):188-204. doi: 10.1002/bdr2.2091. Epub 2022 Sep 30.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators: GlaxoSmithKline PPD

location_country:
Germany
Italy
Portugal
Israel
Argentina
Sweden
Switzerland
Austria
Belgium
United States
Spain
Canada
France


title: An Observational Study of the Clinical Characteristics and Disease Progression of Patients With Lysosomal Acid Lipase Deficiency/Cholesteryl Ester Storage Disease Phenotype

summary: This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).

ReferenceCitation: Burton BK, Silliman N, Marulkar S. Progression of liver disease in children and adults with lysosomal acid lipase deficiency. Curr Med Res Opin. 2017 Jul;33(7):1211-1214. doi: 10.1080/03007995.2017.1309371. Epub 2017 Apr 3.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

ReferenceCitation: Burton BK, Deegan PB, Enns GM, Guardamagna O, Horslen S, Hovingh GK, Lobritto SJ, Malinova V, McLin VA, Raiman J, Di Rocco M, Santra S, Sharma R, Sykut-Cegielska J, Whitley CB, Eckert S, Valayannopoulos V, Quinn AG. Clinical Features of Lysosomal Acid Lipase Deficiency. J Pediatr Gastroenterol Nutr. 2015 Dec;61(6):619-25. doi: 10.1097/MPG.0000000000000935.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Italy
Poland
United Kingdom
Switzerland
United States
Canada
Czech Republic
France

location_facility: 1st Faculty of Medicine Charles University

location_facility: Morgan Stanley Children's Hospital of New York-Presbyterian


type: EudraCT Number

title: A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS

summary: The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

primary_purpose: Other

ReferenceCitation: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Springer-Nature

ipd_sharing: Yes

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

lead_sponsor: Pfizer

location_country:
Italy
India
Slovakia
Hungary
Norway
Romania
Australia
Japan
Belgium
United States
China
Spain
South Africa
Czechia
France

location_facility: Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika

location_facility: Barwon Health - University Hospital Geelong

location_facility: Cliniques Universitaires Saint-Luc, Gastroenterologie

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie

location_facility: West China Hospital of Sichuan University

location_facility: IEO Istituto Europeo di Oncologia, IRCCS


title: A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Poland
Hungary
United Kingdom
Denmark
Australia
Netherlands
Mexico
United States
China
Spain
Canada
Czech Republic


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Long Lesion Sub-trial

acronym: PLATINUM LL

summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be longer than average-sized.

ReferenceCitation: Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

publisher_dissemination: Wiley

ipd_sharing: Undecided

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

location_country:
New Zealand
Australia
Japan
Belgium
United States
Latvia
France

location_facility: Ohio Health Research and Innovation Institute

location_facility: Providence Health & Services - Washington

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

location_facility: MediQuest Research Group Inc. at Munroe Regional Medical Center

location_facility: Oklahoma Foundation for Cardiovascular Research


title: A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

summary: The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

ReferenceCitation: Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.

oa_host_type: publisher

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

ReferenceCitation: Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.

oa_colors: green gold

ReferenceCitation: Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.

ReferenceCitation: Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.

ReferenceCitation: Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.

publisher_dissemination: Oxford University Press

ReferenceCitation: Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.

ReferenceCitation: Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Czechia
France
Hong Kong
United States
Ukraine
Romania
Belgium
China
Peru
Philippines
Italy
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Cobitolimod as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients

acronym: COLLECT

summary: The purpose of this study is to determine if cobitolimod (former called Kappaproct®) is effective in the treatment of chronic active ulcerative colitis patients not responding to available therapy.

ReferenceCitation: Atreya R, Reinisch W, Peyrin-Biroulet L, Scaldaferri F, Admyre C, Knittel T, Kowalski J, Neurath MF, Hawkey C. Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis. Dig Liver Dis. 2018 Oct;50(10):1019-1029. doi: 10.1016/j.dld.2018.06.010. Epub 2018 Jun 22.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

version: acceptedVersion

repositories_concat: Zenodo

lead_sponsor: InDex Pharmaceuticals

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Czechia
France

location_facility:
Site 409
Site 101
Site 204
Site 605
Site 203
Site 503
Site 510
Site 207
Site 403
Site 205
Site 302
Site 603
Site 104
Site 607
Site 606
Site 402
Site 407
Site 501
Site 504
Site 508
Site 509
Site 602
Site 406
Site 702
Site 514
Site 202
Site 511
Site 304
Site 502
Site 103
Site 404
Site 102
Site 405
Site 513
Site 601
Site 507
Site 604


title: Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®

acronym: CogniPlus

summary: Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

lead_sponsor: Bayer

location_country:
Germany
Albania
Portugal
Hungary
Argentina
Algeria
Israel
Netherlands
Tunisia
Belgium
Saudi Arabia
Kazakhstan
Greece
Turkey
Czechia
Egypt
France


title: A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose

summary: The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

ReferenceCitation: Gupta SK, McComsey GA, Lombaard J, Echevarria J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12.

repository_institution: Indiana University - IUScholarWorks

version: submittedVersion

lead_sponsor: Bristol-Myers Squibb

location_country:
Colombia
Hungary
Argentina
Australia
Mexico
United States
Spain
Thailand
South Africa
Chile
Peru
Canada
France

location_facility: North Texas Infectious Disease Consultants

location_facility: Tarrant County Infectious Disease Associates

location_facility: Clinic 42 And International Travel Clinic


title: An Open Label Multicenter Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 in Adult Subjects With Liver Dysfunction Due to Lysosomal Acid Lipase Deficiency Who Previously Received Treatment in Study LAL-CL01

summary: This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysfunction due to lysosomal acid lipase (LAL) deficiency.

ReferenceCitation: Balwani M, Breen C, Enns GM, Deegan PB, Honzik T, Jones S, Kane JP, Malinova V, Sharma R, Stock EO, Valayannopoulos V, Wraith JE, Burg J, Eckert S, Schneider E, Quinn AG. Clinical effect and safety profile of recombinant human lysosomal acid lipase in patients with cholesteryl ester storage disease. Hepatology. 2013 Sep;58(3):950-7. doi: 10.1002/hep.26289. Epub 2013 Mar 28.

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Malinova V, Balwani M, Sharma R, Arnoux JB, Kane J, Whitley CB, Marulkar S, Abel F. Sebelipase alfa for lysosomal acid lipase deficiency: 5-year treatment experience from a phase 2 open-label extension study. Liver Int. 2020 Sep;40(9):2203-2214. doi: 10.1111/liv.14603. Epub 2020 Aug 9.

location_country:
United Kingdom
United States
Czechia
Canada
France


title: Long-Term Open-Label Safety Study of Pomaglumetad Methionil in Patients With Schizophrenia

summary: The purpose of this study is to evaluate the long-term safety of pomaglumetad methionil in participants with schizophrenia.

lead_sponsor: Eli Lilly and Company

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

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


title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

summary: This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

design_allocation: Non-Randomized

location_country:
Poland
New Zealand
Slovakia
Australia
United States
Canada
France


title: A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

acronym: POISE

summary: The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.

ReferenceCitation: Nevens F, Andreone P, Mazzella G, Strasser SI, Bowlus C, Invernizzi P, Drenth JP, Pockros PJ, Regula J, Beuers U, Trauner M, Jones DE, Floreani A, Hohenester S, Luketic V, Shiffman M, van Erpecum KJ, Vargas V, Vincent C, Hirschfield GM, Shah H, Hansen B, Lindor KD, Marschall HU, Kowdley KV, Hooshmand-Rad R, Marmon T, Sheeron S, Pencek R, MacConell L, Pruzanski M, Shapiro D; POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med. 2016 Aug 18;375(7):631-43. doi: 10.1056/NEJMoa1509840.

evidence: open (via free article)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
Pure (Denmark)
UCL Discovery
dspace.library.uu.nl

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Trauner M, Nevens F, Shiffman ML, Drenth JPH, Bowlus CL, Vargas V, Andreone P, Hirschfield GM, Pencek R, Malecha ES, MacConell L, Shapiro D. Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):445-453. doi: 10.1016/S2468-1253(19)30094-9. Epub 2019 Mar 26.

ReferenceCitation: Harms MH, Hirschfield GM, Floreani A, Mayo MJ, Pares A, Liberman A, Malecha ES, Pencek R, MacConell L, Hansen BE. Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis. JHEP Rep. 2020 Sep 29;3(1):100191. doi: 10.1016/j.jhepr.2020.100191. eCollection 2021 Feb.

repositories_concat: PubMed Central;pure.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Bowlus CL, Pockros PJ, Kremer AE, Pares A, Forman LM, Drenth JPH, Ryder SD, Terracciano L, Jin Y, Liberman A, Pencek R, Iloeje U, MacConell L, Bedossa P. Long-Term Obeticholic Acid Therapy Improves Histological Endpoints in Patients With Primary Biliary Cholangitis. Clin Gastroenterol Hepatol. 2020 May;18(5):1170-1178.e6. doi: 10.1016/j.cgh.2019.09.050. Epub 2019 Oct 10.

ReferenceCitation: Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29.

repositories_institution: California Digital Library - eScholarship

lead_sponsor: Intercept Pharmaceuticals

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Dip. Medicina Clinica- Università di Bologna

location_facility: Klinika Gastroenterologii i Hepatologii SP CSK im. prof. K. Gibinskiego SUM

location_facility: Virginia Commonwealth University/McGuire DVAMC

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Dip. Medicina Clinica - Università di Bologna

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "SONOMED"

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Azienda Ospedaliera di Padova - Gastroenterologia

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii

location_facility: Gastroenterologische Gemeinschaftspraxis, Dres. Felten / Hartmann / Hüppe

location_facility: Klinikum der Johann-Wolfgang Goethe Universität Frankfurt am Main

location_facility: University of Texas Southwestern Medical Center

location_facility: Nottingham University Hospitals NHS Trust


title: A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy

summary: The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.

location_country:
Germany
Belgium
United States
Spain
France

location_facility:
Medical And Surgical Specialists, Llc
Carolina Biooncology Institute
Quincy Medical Group
Montgomery Cancer Center
Blue Ridge Cancer Care
Meritus Center For Clinical Research
Local Institution
Marin Specialty Care, Inc.

intervention_type: Biological


title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.

summary: Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).

ReferenceCitation: Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

lead_sponsor: UCB BIOSCIENCES GmbH

sponsor_collaborators:
UCB BIOSCIENCES GmbH
Eden Sarl

location_country:
Finland
Germany
Poland
Australia
Japan
Thailand
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Sweden


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

summary: This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.

ReferenceCitation: Germain DP, Hughes DA, Nicholls K, Bichet DG, Giugliani R, Wilcox WR, Feliciani C, Shankar SP, Ezgu F, Amartino H, Bratkovic D, Feldt-Rasmussen U, Nedd K, Sharaf El Din U, Lourenco CM, Banikazemi M, Charrow J, Dasouki M, Finegold D, Giraldo P, Goker-Alpan O, Longo N, Scott CR, Torra R, Tuffaha A, Jovanovic A, Waldek S, Packman S, Ludington E, Viereck C, Kirk J, Yu J, Benjamin ER, Johnson F, Lockhart DJ, Skuban N, Castelli J, Barth J, Barlow C, Schiffmann R. Treatment of Fabry's Disease with the Pharmacologic Chaperone Migalastat. N Engl J Med. 2016 Aug 11;375(6):545-55. doi: 10.1056/NEJMoa1510198.

repositories_concat: UCL Discovery

repositories_institution: University College London - UCL Discovery

lead_sponsor: Amicus Therapeutics

location_country:
Italy
United Kingdom
Argentina
Denmark
Australia
Brazil
Belgium
United States
Spain
Turkey
Canada
Egypt
France


title: A Multicentre Randomized Controlled Trial of the Use of Extended Peri-Operative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colorectal Cancer

summary:
The human body has a natural stress response to surgery, including the formation of blood clots. This response to surgery has been shown to increase metastases (the spread of cancer cells to other organs in the body). These metastases cannot be seen at the time of surgery but when they grow into new tumors, the cancer has recurred (come back). A blood thinner called "low molecular weight heparin" (LMWH) can suppress the development of metastases after surgery in animal experiments. The investigators want to see if giving patients with colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance of their cancer spreading to other organs (metastases) and coming back (recurrence).

The investigators need 1075 patients to answer our scientific question. Patients who give informed consent will be randomly put into one of two groups, the experimental group and the control group. The patients in the control group will be treated with LMWH starting a few hours after surgery and every day until they leave the hospital. This is how most patients are treated after colon cancer surgery (standard care). The patients in the experimental group will be treated with LMWH for a longer period of time, starting on the day they agree to have surgery and continuing for two months after surgery. All the patients will be followed for at least three years after surgery to find out if their cancer has recurred (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in patients with colorectal cancer, it would improve the health and quality of life for these patients.

primary_purpose: Prevention

ReferenceCitation: Auer RC, Ott M, Karanicolas P, Brackstone MR, Ashamalla S, Weaver J, Tagalakis V, Boutros M, Stotland P, Marulanda AC, Moloo H, Jayaraman S, Patel S, Le Gal G, Spadafora S, MacLellan S, Trottier D, Jonker D, Asmis T, Mallick R, Pecarskie A, Ramsay T, Carrier M; PERIOP-01 investigators. Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial. BMJ. 2022 Sep 13;378:e071375. doi: 10.1136/bmj-2022-071375.

evidence: open (via page says license)

publisher_dissemination: British Medical Journal

lead_sponsor: Ottawa Hospital Research Institute

location_country: Canada Belgium France

location_facility:
London Health Research Institute
Health Sciences North
CHRU Brest
Ghent University Hospital
Hamilton Health Sciences Corporation
Kingston General Hospital
St. Joseph's Health Centre
Montfort Hospital
Humber River Hospital
Jewish General Hospital
The Ottawa Hospital
Queensway Carleton Hospital
North York General Hospital
Sunnybrook Health Science Centre
Sault Area Hospital
Mount Sinai Hospital


title: A Multicenter Prospective Cohort Management Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound

acronym: SSPE

summary:
Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological test called computed tomography (CT scan). As technology advances, the CT scans are able to detect smaller and smaller blood clots. Over time, the frequency of blood clots in the pulmonary arteries has increased significantly (CT scan are now detecting very small blood clots that the investigators could not see before). As a result, more and more people are on blood thinners to treat these small blood clots but their true clinical significance is unknown.

The management of blood thinners is costly and also utilizes scarce healthcare resources. These blood thinners need to be monitored with frequent blood work. Furthermore, every year, approximately 3 percent of patients on blood thinners will have a major bleeding event requiring medical attention.

The investigators don't think that treating these small blood clots in the pulmonary arteries detected on CT scan is worth the risk of bleeding from the blood thinners.

The main goal of this study is to find out if it is safe to not treat very small blood clots in the pulmonary arteries.

The investigators plan to follow 300 patients with small blood clots in their lungs for 90 days. These patients will not be treated with blood thinners but will be followed closely with other non-invasive tests to avoid progression or recurrence of blood clots.

ReferenceCitation: Le Gal G, Kovacs MJ, Bertoletti L, Couturaud F, Dennie C, Hirsch AM, Huisman MV, Klok FA, Kraaijpoel N, Mallick R, Pecarskie A, Pena E, Phillips P, Pichon I, Ramsay T, Righini M, Rodger MA, Roy PM, Sanchez O, Schmidt J, Schulman S, Shivakumar S, Trinh-Duc A, Verdet R, Vinsonneau U, Wells P, Wu C, Yeo E, Carrier M; SSPE Investigators. Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation : A Multicenter Prospective Cohort Study. Ann Intern Med. 2022 Jan;175(1):29-35. doi: 10.7326/M21-2981. Epub 2021 Nov 23.

publisher_dissemination: American College of Physicians

sponsor_collaborators:
Ottawa Hospital Research Institute
University Hospital, Brest

location_country: Canada Switzerland France

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Sir Mortimer B. Davis Jewish General Hospital


title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

acronym: ASPIRE

summary: The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A.

ReferenceCitation: Nolan B, Mahlangu J, Pabinger I, Young G, Konkle BA, Barnes C, Nogami K, Santagostino E, Pasi KJ, Khoo L, Winding B, Yuan H, Fruebis J, Rudin D, Oldenburg J. Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study. Haemophilia. 2020 May;26(3):494-502. doi: 10.1111/hae.13953. Epub 2020 Mar 30.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Nolan B, Mahlangu J, Perry D, Young G, Liesner R, Konkle B, Rangarajan S, Brown S, Hanabusa H, Pasi KJ, Pabinger I, Jackson S, Cristiano LM, Li X, Pierce GF, Allen G. Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A. Haemophilia. 2016 Jan;22(1):72-80. doi: 10.1111/hae.12766. Epub 2015 Jul 27.

lead_sponsor: Bioverativ Therapeutics Inc.

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Canada
France
Hong Kong
Switzerland
United States
India
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
South Africa
Israel

location_facility:
Research site
Research Site
Sir Yue Kong Pao Center for Cancer
Children Cancer Centre


title: A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

summary: This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.

lead_sponsor: Array BioPharma

location_country:
Italy
United Kingdom
Australia
Switzerland
United States
Spain
France

location_facility: University of Texas/MD Anderson Cancer Center Dept. of Onc.

location_facility: H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC

location_facility: Memorial Sloan Kettering Cancer Center Onc. Dept

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

location_facility: University of California San Diego - Moores Cancer Center Dept Onc


title: A Phase 2, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Inhaled Iloprost on Endurance Time During Cardiopulmonary Exercise Testing in Patients With Pulmonary Hypertension Secondary to Chronic Obstructive Pulmonary Disease

summary: This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.

lead_sponsor: Actelion

location_country:
United States
Spain
France

location_facility: Los Angeles Biomedical Research Institute

location_facility: University of Oklahoma Health Sciences Center


title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

summary: This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

ReferenceCitation: Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Jun;17(6):811-821. doi: 10.1016/S1470-2045(16)00106-6. Epub 2016 May 4.

lead_sponsor: Genentech, Inc.

location_country:
Germany
New Zealand
Argentina
Australia
Thailand
Chile
Canada
France
Czech Republic
Hong Kong
Denmark
United States
Belgium
Malaysia
Peru
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


title: A Long-Term Study for Extended BMN 701 Treatment of Patients With Pompe Disease Who Have Participated in a BMN 701 Study

summary: This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion every 2 weeks (qow) to patients with late-onset Pompe disease.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
New Zealand
United Kingdom
Australia
United States
France

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Villa Metabolica, ZKJM MC University Mainz

location_facility: Auckland City and Starship Children's Hospital

location_facility: University of Florida College of Medicine

location_facility: Univ of California San Diego School of Medicine


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

ReferenceCitation: Bailey DB Jr, Berry-Kravis E, Wheeler A, Raspa M, Merrien F, Ricart J, Koumaras B, Rosenkranz G, Tomlinson M, von Raison F, Apostol G. Mavoglurant in adolescents with fragile X syndrome: analysis of Clinical Global Impression-Improvement source data from a double-blind therapeutic study followed by an open-label, long-term extension study. J Neurodev Disord. 2016;8:1. doi: 10.1186/s11689-015-9134-5. Epub 2015 Dec 15.

title: An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients With Fragile X Syndrome

location_country:
Germany
Italy
Israel
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
France


title: An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B

acronym: B-YOND

summary:
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B.

The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

ReferenceCitation: Shapiro AD, Pasi KJ, Ozelo MC, Kulkarni R, Barnowski C, Winding B, Szamosi J, Lethagen S. Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B. Res Pract Thromb Haemost. 2018 Nov 29;3(1):109-113. doi: 10.1002/rth2.12163. eCollection 2019 Jan.

repositories_concat: PubMed Central;qmro.qmul.ac.uk

repositories_institution: Queen Mary University of London - Queen Mary Research Online

location_country:
Germany
Ireland
Italy
Poland
India
United Kingdom
Hong Kong
Australia
Brazil
Japan
Netherlands
Belgium
Sweden
United States
China
South Africa
Canada
France

location_facility:
Research site
Research Site


lead_sponsor: Amgen

summary: This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.

title: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

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

location_country:
Poland
Argentina
Japan
Brazil
Czechia
France
Lithuania
Hungary
Latvia
Ukraine
Belgium
Peru
Italy
Austria
Spain
Panama
South Africa
Russian Federation
Israel


title: Randomised, Openlabel Study Evaluating Efficacy and Safety of Maraviroc as a Switch for Either NRTI or PI/r in HIV-1 Infected Individuals With Stable, Well-Controlled Plasma HIV-RNA While Taking Their First N(t)RTI + PI/r Regimen of cART

acronym: MARCH

summary:
MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r.

The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.

ReferenceCitation: Pett SL, Amin J, Horban A, Andrade-Villanueva J, Losso M, Porteiro N, Sierra Madero J, Belloso W, Tu E, Silk D, Kelleher A, Harrigan R, Clark A, Sugiura W, Wolff M, Gill J, Gatell J, Fisher M, Clarke A, Ruxrungtham K, Prazuck T, Kaiser R, Woolley I, Arnaiz JA, Cooper D, Rockstroh JK, Mallon P, Emery S; Maraviroc Switch (MARCH) Study Group. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016 Jul 1;63(1):122-32. doi: 10.1093/cid/ciw207. Epub 2016 Apr 5.

ReferenceCitation: Tu E, Swenson LC, Land S, Pett S, Emery S, Marks K, Kelleher AD, Kaye S, Kaiser R, Schuelter E, Harrigan R; MARCH Laboratory Group and the MARCH Study Group. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013 Jul;51(7):2063-71. doi: 10.1128/JCM.00510-13. Epub 2013 Apr 17.

lead_sponsor: Kirby Institute

collaborators:
ViiV Healthcare
Pfizer

sponsor_collaborators:
Kirby Institute
ViiV Healthcare
Pfizer

location_country:
Germany
Ireland
Poland
United Kingdom
Argentina
Australia
Japan
Mexico
Spain
Thailand
Chile
Canada
France

location_facility: Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE

location_facility: University Health Network/Toronto General Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Nacional Prof Alejandro Posadas

location_facility: Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS

location_facility: Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb

location_facility: University of Bonn, Med J. Immunologische Siudienzenirale

location_facility: Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover

location_facility: Coventry and Warwickshire Partnership Trust

location_facility: Brisbane Sexual Health and HIV Service (formerly AMU)

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)

location_facility: Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER

location_facility: Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)


title: An Open-Label, Multi-Center, International Study to Investigate Drug-Drug Interactions Between AT2220 and Alglucosidase Alfa in Patients With Pompe Disease

summary: This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

location_country:
United States
United Kingdom
Canada
France


title: A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)

summary: A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).

lead_sponsor: Catalyst Pharmaceuticals, Inc.

location_country:
Germany
Poland
Hungary
United States
Spain
Serbia
Russian Federation
France


type: U.S. NIH Grant/Contract

title: Natural History and Biospecimen Repository for Dystonia; Comprehensive Rating Tools for Cervical Dystonia; Validity & Reliability of Diagnostic Methods & Measures of Spasmodic Dysphonia

acronym: DCP

summary: Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.

time_perspective: Other

ReferenceCitation: Patel N, Hanfelt J, Marsh L, Jankovic J; members of the Dystonia Coalition. Alleviating manoeuvres (sensory tricks) in cervical dystonia. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):882-4. doi: 10.1136/jnnp-2013-307316. Epub 2014 May 14.

ipd_sharing_description: Data is available to researchers with appropriate ethics board approvals. Researchers may contact the Dystonia Coalition PI or coordinator at Emory University or the RDCRN Data Management and Coordination Center for more information.

lead_sponsor: Emory University

collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

location_country:
Germany
Italy
United Kingdom
Australia
United States
Canada
France

location_facility: University College London Institute of Neurology

location_facility: Houston Methodist Neurological Institute

location_facility: University of Pennsylvania, Parkinson's Disease and Movement Disorders Center

location_facility: Parkinson's and Movement Disorders Center of Maryland

location_facility: University Hospital of Schleswig-Holstein

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Parkinson's and Movement Disorders Institute


title: A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Patients With Advanced Solid Tumors

summary:
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or oxaliplatin, leucovorin, 5-fluorouracil (5-FU) (mFOLFOX6 chemotherapy) (Arm B), or paclitaxel (Arm C), in participants with advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. Arm D will assess the safety, tolerability, and pharmacokinetics of ipatasertib administered in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer (CRPC). There will be two stages within each arm of this study: a dose-escalation stage (Stage 1) and a cohort-expansion stage (Stage 2). In Stage 1, approximately 3 to 6 cohorts in Arms A and B and 1 to 2 cohorts in Arms C and D will be evaluated to determine the maximum tolerated dose (MTD) of ipatasertib in a given combination. Additional participants will be enrolled in Stage 2 (cohort expansion), to further characterize the safety and tolerability of ipatasertib in these combinations and to confirm a potential recommended Phase II dose of ipatasertib for each regimen.

NOTE: Arms A, B, and C are closed.

ReferenceCitation: Isakoff SJ, Tabernero J, Molife LR, Soria JC, Cervantes A, Vogelzang NJ, Patel MR, Hussain M, Baron A, Argiles G, Conkling PR, Sampath D, Maslyar D, Patel P, Chan W, Gendreau S, Musib L, Xu N, Ma H, Lin K, Bendell J. Antitumor activity of ipatasertib combined with chemotherapy: results from a phase Ib study in solid tumors. Ann Oncol. 2020 May;31(5):626-633. doi: 10.1016/j.annonc.2020.02.007. Epub 2020 Feb 20.

location_country:
United States
Spain
United Kingdom
France

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale


title: An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

summary: The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

primary_purpose: Basic Science

ReferenceCitation: Ross-Macdonald P, Walsh AM, Chasalow SD, Ammar R, Papillon-Cavanagh S, Szabo PM, Choueiri TK, Sznol M, Wind-Rotolo M. Molecular correlates of response to nivolumab at baseline and on treatment in patients with RCC. J Immunother Cancer. 2021 Mar;9(3):e001506. doi: 10.1136/jitc-2020-001506.

ReferenceCitation: Zhou Q, Qi Y, Wang Z, Zeng H, Zhang H, Liu Z, Huang Q, Xiong Y, Wang J, Chang Y, Bai Q, Xia Y, Wang Y, Liu L, Xu L, Dai B, Guo J, Zhu Y, Zhang W, Xu J. CCR5 blockade inflames antitumor immunity in BAP1-mutant clear cell renal cell carcinoma. J Immunother Cancer. 2020 Apr;8(1):e000228. doi: 10.1136/jitc-2019-000228.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharma USA Inc

location_facility: University Of Wisconsin Carbone Cancer Center

location_facility: The Bunting-Blaustein Cancer Research Building

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center


title: A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype

summary: This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Italy
United Kingdom
United States
Canada
France

location_facility: North Shore Long Island Jewish Medical Center

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Instituto Giannina Gaslini- Ospedale Pediatrico IRCCS


title: A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies

summary: The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

ReferenceCitation: Thijssen R, Ter Burg J, Garrick B, van Bochove GG, Brown JR, Fernandes SM, Rodriguez MS, Michot JM, Hallek M, Eichhorst B, Reinhardt HC, Bendell J, Derks IA, van Kampen RJ, Hege K, Kersten MJ, Trowe T, Filvaroff EH, Eldering E, Kater AP. Dual TORK/DNA-PK inhibition blocks critical signaling pathways in chronic lymphocytic leukemia. Blood. 2016 Jul 28;128(4):574-83. doi: 10.1182/blood-2016-02-700328. Epub 2016 May 27.

ReferenceCitation: Munster P, Mita M, Mahipal A, Nemunaitis J, Massard C, Mikkelsen T, Cruz C, Paz-Ares L, Hidalgo M, Rathkopf D, Blumenschein G Jr, Smith DC, Eichhorst B, Cloughesy T, Filvaroff EH, Li S, Raymon H, de Haan H, Hege K, Bendell JC. First-In-Human Phase I Study Of A Dual mTOR Kinase And DNA-PK Inhibitor (CC-115) In Advanced Malignancy. Cancer Manag Res. 2019 Dec 13;11:10463-10476. doi: 10.2147/CMAR.S208720. eCollection 2019.

lead_sponsor: Celgene

location_country:
United States
Spain
Germany
France

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute

location_facility: Henry Ford Medical Center - New Center One

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute Drug Development Unit


title: A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands

summary: The primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies that have progressed despite standard therapy or for which no effective standard therapy exists

status: Active, not recruiting

ReferenceCitation: Rodon J, Argiles G, Connolly RM, Vaishampayan U, de Jonge M, Garralda E, Giannakis M, Smith DC, Dobson JR, McLaughlin ME, Seroutou A, Ji Y, Morawiak J, Moody SE, Janku F. Phase 1 study of single-agent WNT974, a first-in-class Porcupine inhibitor, in patients with advanced solid tumours. Br J Cancer. 2021 Jul;125(1):28-37. doi: 10.1038/s41416-021-01389-8. Epub 2021 May 3.

location_country:
Germany
Italy
Netherlands
United States
Spain
Canada
France

location_facility: University of Michigan Comprehensive Cancer Center Onc Dept.

location_facility: University of Texas/MD Anderson Cancer Center MD Anderson 2

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins


title: Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe: Predicting Postoperative Pulmonary Complications in Europe: a 7-day Data Collection, Prospective, Observational Study

acronym: PERISCOPE

summary: Prospective Evaluation of a RIsk Score for postoperative pulmonary COmPlications in Europe (PERISCOPE) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.

ReferenceCitation: Canet J, Hardman J, Sabate S, Langeron O, Abreu MG, Gallart L, Belda J, Markstaller K, Pelosi P, Mazo V. PERISCOPE study: predicting post-operative pulmonary complications in Europe. Eur J Anaesthesiol. 2011 Jun;28(6):459-61. doi: 10.1097/EJA.0b013e328344be2d. No abstract available.

ReferenceCitation: Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

ReferenceCitation: Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.

ReferenceCitation: Russotto V, Sabate S, Canet J; PERISCOPE group; of the European Society of Anaesthesiology (ESA) Clinical Trial Network. Development of a prediction model for postoperative pneumonia: A multicentre prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):93-104. doi: 10.1097/EJA.0000000000000921.

lead_sponsor: European Society of Anaesthesiology

location_country:
Germany
Poland
Bosnia and Herzegovina
Luxembourg
Turkey
Croatia
Czechia
France
Lithuania
Portugal
Hungary
Switzerland
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
Albania
Spain
Russian Federation

location_facility: University of Milano, Ospedale San Paolo Dpt Of Anaesthesia and Intensive Care

location_facility: ZithaKlinik, Anaesthesiology and Intensive Care

location_facility: Hospital Universitario de Móstoles, anestesiología y Reanimación

location_facility: European Institute of Oncology,Anaesthesia and Intensive Care

location_facility: Emergency Clinical Hospital of Constanta, Department of Anaesthesiology and Intensive Care

location_facility: Centro Hospitalar de Lisboa Ocidental, Serviço de Anestesia

location_facility: Hospital Universitari Germans Trias i Pujol, Anaesthesiology

location_facility: University Hospital Bonn, Anesthesiology

location_facility: MISEK Kft., Anaesthesiology and Intensive Care Unit

location_facility: Clinica Universidad de Navarra, Anaesthesia

location_facility: Medical Faculty of Istanbul, Istanbul University, Anaesthesiology

location_facility: Faculty Hospital Brno, department of Anaesthesiology and Intensive Care Medicine

location_facility: Masaryks hospital Usti nad labem, Dept. of Anesthesia and intensive medicine

location_facility: Hospital of Lithuanian University of Health Sciences, Clinic of Anaesthesiology

location_facility: Instituto Português de Oncologia, Departement of Anesthesiology

location_facility: General Hospital "Prim.dr Abdulah Nakas" Departement of Anaesthesia and intensive care

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Tartu University Hospital Clinic of Anaesthesiology and Intensive Care

location_facility: Hospital Arnau de Vilanova Departement of Anesthesiology

location_facility: Azienda USL n. 5 di Pisa Ospedale F. Lotti Anestesia e Rianimazione

location_facility: Azienda Ospedaliera Padova, Anesthesia and Intensive Care Clinic, Department of Pharmacology and Anesthesiology

location_facility: St.Katherine Hospital of Cardiology Anesthesiology & Pain Treatment

location_facility: Hospital Santa Maria, Departement of Anesthesiology

location_facility: Vall d'Hebron University Hospital, Anaesthesiology

location_facility: University Hospital Rijeka Anaesthesiology and Intensive care

location_facility: Corporació Sanitària Parc Taulí, Anaesthesiology

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy, Anaesthesiology and Intensive Care

location_facility: Emergency County Hospital Clinic of Anesthesia and Intensive Care, Intensive Care and Anesthesiology

location_facility: Hospital del Tajo Anaesthesia and Reanimation

location_facility: Klinikum Darmstadt GmbH Anesthesiology, Intensive Care and pain medicin

location_facility: Virgen del Rocio General Universitary Hospital;Anaesthesiology

location_facility: Hôpital Pitié-Salpêtrière, Anesthesiology and Critical Care

location_facility: Krasnoyarsk State Medical University,Anesthesiology and Intensive Care

location_facility: Hospital de Denia,Anesthesia and Intensive Care

location_facility: University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy

location_facility: University Hospital centre "Mother Theresa" Anesthesia & critical Care

location_facility: Hospitais da Universidade de Coimbra, EPE. Departement of Anesthesiology

location_facility: Hospital Universitario Rio Hortgea, Anaesthesia and Surgical Critical Care

location_facility: Hospital Universitario de La Princesa, Anesthesiology

location_facility: Hospital Clínic Universitari de València, Anestesiología y Reanimación

location_facility: Universitätsmedizin Mainz, Departement of Anesthesiology

location_facility: Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

location_facility: Hospital General de La Palma, Anestesiología y Reanimación

location_facility: Hospital General Universitario Alicante, Anaesthesiology

location_facility: Vilnius University Hospital Santariskiu Clinics, Center of Anesthesiology, Intensive Care and Pain Treatment

location_facility: P Stradins Clinical University hospital, Departement of Anesthesiology

location_facility: Consorcio Hospital General Universitario, Anesthesiology, Critical Care and Pain Relief Unit

location_facility: Emergency Institute of Cardiovascular Diseases Prof Dr C. C. Iliescu, Cardiac Anesthesia and Intensive Care

location_facility: Azienda Ospedaliera S. Croce e Carle, Anesthesia


type: Registry Identifier

title: An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Formulation of MLN9708 Administered Weekly in Adult Patients With Relapsed or Refractory Light-Chain (AL) Amyloidosis Who Require Further Treatment

summary: This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.

ReferenceCitation: Sanchorawala V, Comenzo R, Zonder J, Kukreti V, Cohen A, Dispenzieri A, et al. MLN9708, an investigational oral proteasome inhibitor (PI), in relapsed or refractory lightchain (AL) amyloidosis. Clinical Lymphoma Myeloma and Leukemia 2013;13(suppl 1):S153-4; abstr P-229.

ReferenceCitation: Sanchorawala V, Zonder J, Comenzo R, Schönland S, Dispenzieri A, Berg D, et al. Poster Presentation: Phase 1 study of MLN9708, a novel, investigational oral proteasome inhibitor, in patients with relapsed or refractory light-chain amyloidosis. XIII International Symposium on Amyloidosis, Groningen, The Netherlands 2012.

ReferenceCitation: Merlini G, Sanchorawala V, Zonder J, Kukreti V, Schonland S, Jaccard A, et al. MLN9708, a novel, investigational oral proteasome inhibitor, in patients with relapsed or refractory light-chain amyloidosis (AL): results of a phase 1 study. In: 54th ASH Annual Meeting and Exposition; 2012 8-11 December; Atlanta, GA; p. abstr 731.

ReferenceCitation: Sanchorawala V, Palladini G, Kukreti V, Zonder JA, Cohen AD, Seldin DC, Dispenzieri A, Jaccard A, Schonland SO, Berg D, Yang H, Gupta N, Hui AM, Comenzo RL, Merlini G. A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis. Blood. 2017 Aug 3;130(5):597-605. doi: 10.1182/blood-2017-03-771220. Epub 2017 May 26. Erratum In: Blood. 2020 Mar 26;135(13):1071.

publisher_dissemination: American Society of Hematology

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Germany
Italy
United States
Canada
France

location_facility: Amyloidosis Research & Treatment Center, Fondazione IRCCS Policlinico San Matteo

location_facility: CHU Limoges, Department of Hematology and Cell Therapy, Reference Center for AL amyloidosis

location_facility: Universitatsklinikum Heidelberg Innere Medizin V; Hamatologie, Onkologie und Rheumatologie


title: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

acronym: PRIMUS

summary: Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.

lead_sponsor: HiberCell, Inc.

location_country:
United States
Germany
Puerto Rico
France

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care

location_facility: Ellis Fischel Cancer Center at University of Missouri- Columbia

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Toledo Community Oncology Program- Toledo Community Hospital

location_facility: Medizinisches Versorgungszentrum Ãrzteforum Seestrabe

location_facility: Ãrzteforum Henningsdorf Darmzentrum Oberhavel

location_facility: Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin

location_facility: University of Louisville/James Brown Cancer Center

location_facility: Hematology and Oncology Associates of Central NY

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie

location_facility: Texas Oncology - Dallas Presbyterian Hospital


title: A PHASE 1 STUDY OF PF-05082566 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED CANCER, AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA (NHL)

summary: A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).

ReferenceCitation: Gopal AK, Levy R, Houot R, Patel SP, Popplewell L, Jacobson C, Mu XJ, Deng S, Ching KA, Chen Y, Davis CB, Huang B, Fly KD, Thall A, Woolfson A, Bartlett NL. First-in-Human Study of Utomilumab, a 4-1BB/CD137 Agonist, in Combination with Rituximab in Patients with Follicular and Other CD20+ Non-Hodgkin Lymphomas. Clin Cancer Res. 2020 Jun 1;26(11):2524-2534. doi: 10.1158/1078-0432.CCR-19-2973. Epub 2020 Mar 6.

evidence: oa repository (via page says license)

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Segal NH, He AR, Doi T, Levy R, Bhatia S, Pishvaian MJ, Cesari R, Chen Y, Davis CB, Huang B, Thall AD, Gopal AK. Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer. Clin Cancer Res. 2018 Apr 15;24(8):1816-1823. doi: 10.1158/1078-0432.CCR-17-1922. Epub 2018 Mar 16.

lead_sponsor: Pfizer

location_country:
Italy
Australia
Japan
United States
France

location_facility: Az. Ospedaliera-Univer. di Bologna Policlinico S. Orsola Malpighi

location_facility: Research Administration Office: Clinical Research Unit

location_facility: Santa Monica UCLA Hematology & Oncology Clinic

location_facility: UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)

location_facility: The University of Texas - M.D. Anderson Cancer Center

location_facility: Georgetown University Medical Center Department of Pharmacy, Research

location_facility: Washington University School of Medicine

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: UC San Diego Moores Cancer Center-Investigational Drug Services

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: Washington University Infusion Center Pharmacy


title: A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma

summary: This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.

location_country:
United States
Germany
France

location_facility: Washington University School of Medicine Dept. of WUSTL

location_facility: H. Lee Moffitt Cancer Center & Research Institute SC - 3

location_facility: Fred Hutchinson Cancer Research Center Fred Hutchinson

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Hackensack University Medical Center Multiple Myeloma Division